June 14, 2008Sentinel System to Monitor Medical Product Safety Sentinel System to Monitor Medical Product Safety
FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Requests Recall of Xiadafil VIP Tabs FDA Requests Recall of Xiadafil VIP Tabs
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA: Florida, Mexico suspects in tomato outbreak - Baltimore Sun FDA: Florida, Mexico suspects in tomato outbreak - Baltimore Sun
WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.baltimoresun.com Salmonella Sickens Fla. Man - The Ledger A Southwest Florida man is the state's first victim of the salmonella outbreak tied to raw tomatoes. State Health Department officials say the unidentified man got sick after eating tomatoes during a visit to New York. Health Department spokeswoman Source: www.theledger.com Tomatoes Not Chopped From This Menu - NPR News Preliminary data suggest that raw, red tomatoes are the cause of a salmonella outbreak that has infected at least 145 people nationwide since mid-April, according to the Food and Drug Administration. Source: www.npr.org Food Safety Plan by U.S. FDA Lacks Costs, Timeline (Update2) - Bloomberg June 12 (Bloomberg) -- The U.S. Food and Drug Administration has failed to provide costs or deadlines for a plan to improve food safety even as tainted tomatoes have sickened Americans, according to a report to Congress. The agency oversees the Source: www.bloomberg.com Why it takes so long to trace a bad tomato - Los Angeles Times WASHINGTON -- Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.latimes.com U.S. restaurant chain linked to 9 cases of tomato-borne salmonella - Xinhua News Agency LOS ANGELES, June 14 (Xinhua) -- Two outlets of a restaurant chain might be linked with the sickening of nine people by a salmonella outbreak, a newspaper report said on Saturday. The sick ate fresh tomatoes tained by salmonella at two restaurants Source: news.xinhuanet.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com US salmonella scare halts Mexican tomato exports, floods local markets - International Herald Tribune MEXICO CITY : Export-quality tomatoes labeled "Ready to Eat" in English flooded Mexico City markets on Thursday after a salmonella scare in the U.S. trapped them south of the border. The U.S. Food and Drug Administration has warned consumers against Source: www.iht.com FDA Backs NYC In Calories-On-Menu Debate - CBS 2 NEW YORK (AP) ― The Food and Drug Administration believes the city has a right to force chain restaurants to post calorie counts on menu boards, a government lawyer told a federal appeals court on Thursday, but the court did not immediately decide Source: wcbstv.com Controlling Cholesterol with Statins Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30)
Fresca Italia of Brisbane, CA is recalling Burrata because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. FDA diligently pursuing source of tainted tomatoes - Houston Chronicle FDA diligently pursuing source of tainted tomatoes - Houston Chronicle
WASHINGTON — Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.chron.com Salmonella Sickens Fla. Man - The Ledger A Southwest Florida man is the state's first victim of the salmonella outbreak tied to raw tomatoes. State Health Department officials say the unidentified man got sick after eating tomatoes during a visit to New York. Health Department spokeswoman Source: www.theledger.com Congressional Report Criticizes FDA for Food Safety - Forbes THURSDAY, June 12 (HealthDay News) -- With the ongoing outbreak of salmonella-contaminated tomatoes as a backdrop, Congressional investigators said Thursday that the U.S. Food and Drug Administration has failed to meet its own stated goals of Source: www.forbes.com US drug agency issues precautionary note on silver dental fillings - International Herald Tribune WASHINGTON : Silver dental fillings contain mercury, and the U.S. government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web Source: www.iht.com Teva wins tentative FDA approval for drug - Forbes Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. said Thursday the U.S. Food and Drug Administration tentatively approved the company's application to market a generic version of hypertension drug Diovan. The company said the FDA Source: www.forbes.com Restaurant chain linked to 9 cases of tomato-borne salmonella - Chicago Tribune Nine people sickened by a salmonella outbreak linked to fresh tomatoes ate at two restaurants from the same chain, federal officials confirmed Friday. The chain's name and restaurant location are confidential, said David Acheson, the associate Source: www.chicagotribune.com Food Safety Plan by U.S. FDA Lacks Costs, Timeline (Update2) - Bloomberg June 12 (Bloomberg) -- The U.S. Food and Drug Administration has failed to provide costs or deadlines for a plan to improve food safety even as tainted tomatoes have sickened Americans, according to a report to Congress. The agency oversees the Source: www.bloomberg.com US mulls private drug checks despite device lessons - Guardian Unlimited On Monday, U.S. Food and Drug Administration Commissioner Andrew von Eschenbach requested an extra $275 million for the agency's 2009 budget, in part to allow quicker entry for imports certified by private parties. Source: www.guardian.co.uk Michelle Smith: U.S. Food and Drug Administration - Thepacker.com Michelle Smith: U.S. Food and Drug Administration - Thepacker.com
Web Editor’s note: This q&a is a significantly extended version of the piece that appears in The Packer’s June 2 print and digital editions. (June 3) From the U.S. Food and Drug Administration’s Good Agricultural Practices guidance issued in Source: thepacker.com Salmonella Sickens Fla. Man - The Ledger A Southwest Florida man is the state's first victim of the salmonella outbreak tied to raw tomatoes. State Health Department officials say the unidentified man got sick after eating tomatoes during a visit to New York. Health Department spokeswoman Source: www.theledger.com Human memory, tomato-sale method hinder investigation - Houston Chronicle WASHINGTON — Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.chron.com Lawmakers approve subpoenas over food testing - Newsday WASHINGTON - Lawmakers voted to subpoena nine companies responsible for analyzing the most dangerous food entering the country as part of an investigation that gained more urgency with an outbreak of salmonella from tomatoes. For months, a House Source: www.newsday.com FDA backs new tests to monitor drug safety - San Francisco Gate del.icio.us Drug regulators in the United States and Europe are encouraging pharmaceutical companies to use a set of sensitive new tests that can pick up early signs that an experimental medicine might cause kidney damage. The joint endorsement Source: www.sfgate.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com Why it takes so long to trace a bad tomato - Washington Post Resize Text WASHINGTON -- Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one Source: www.washingtonpost.com Chipotle Mexican Grill Incorporated - Chicago Tribune Restaurants, fast-food chains and supermarkets across Southern California removed fresh red Roma, plum and red round tomatoes from their shelves and took them off their menus this weekend as the U.S. government warned of a widening outbreak of Source: www.chicagotribune.com FDA Backs NYC In Calories-On-Menu Debate - WJZ NEW YORK (AP) ― The Food and Drug Administration believes the city has a right to force chain restaurants to post calorie counts on menu boards, a government lawyer told a federal appeals court on Thursday, but the court did not immediately decide Source: wjz.com Outback Steakhouse Incorporated - Chicago Tribune O'Charley's, a casual dining chain based in Nashville, Tenn., plans to open its first restaurant in the Orlando market, according to a news release. The chain said its franchisee – a division of Covelli Enterprises -- has signed a 10-year lease for Source: www.chicagotribune.com FDA: Florida, Mexico suspects in tomato outbreak - Newsday FDA: Florida, Mexico suspects in tomato outbreak - Newsday
WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.newsday.com FDA backs new tests to monitor drug safety - San Francisco Gate Drug regulators in the United States and Europe are encouraging pharmaceutical companies to use a set of sensitive new tests that can pick up early signs that an experimental medicine might cause kidney damage. The joint endorsement Friday of the Source: www.sfgate.com Why it takes so long to trace a bad tomato - Washington Post Resize Text WASHINGTON -- Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one Source: www.washingtonpost.com FDA Considers Additional Test Results When Assessing New Drug Safety - eMaxHealth.com In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven Source: www.emaxhealth.com FDA diligently pursuing source of tainted tomatoes - Houston Chronicle WASHINGTON — Food and Drug Administration detectives had a hot lead, narrowing down on a grower who just might have supplied salmonella-tainted tomatoes. Then the patient changed her story: She'd eaten a round tomato, not a Roma one after all. "We Source: www.chron.com J&J’s Psoriasis Drug Promising, But May Boost Cancer Risk - The Money Times Johnson & Johnson’s new experimental psoriasis drug, Ustekinumab, appears effective at treating the severe skin disease, but extended use may raise the risk of cancer, the U.S. Food and Drug Administration said on Friday. "Long-term use of Source: www.themoneytimes.com U.S. tomato scare has Mexico frightened about lost profits - Chicago Sun-Times MEXICO CITY -- Export-quality tomatoes labeled ''Ready to Eat'' in English flooded Mexico City markets on Thursday after a salmonella scare in the U.S. trapped them south of the border. The U.S. Food and Drug Administration has warned consumers Source: www.suntimes.com Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA investigating TNF blockers and cancer risk in children and young adults. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Recalls and Safety Alerts: Neupro Patches Recalled Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th... FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. FDA generic drug reviews delayed, report finds - Reuters UK FDA generic drug reviews delayed, report finds - Reuters UK
WASHINGTON (Reuters) - The U.S. Food and Drug Administration failed to review on time nearly half the applications from generic drug makers seeking approval to sell cheaper versions of brand-name pharmaceuticals, according to a government report Source: uk.reuters.com FDA: Florida, Mexico suspects in tomato outbreak - Newsday WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.newsday.com FDA: Fla., Mexico suspects in tomato outbreak - Chicago Sun-Times WASHINGTON---- Parts of Florida and Mexico were supplying ''the vast majority'' of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed Source: www.suntimes.com Tomato outbreak just a wake-up call, says national food expert - Macomb Daily The U.S. Food and Drug Administration is scrambling to trace the source of 144 reported cases of salmonella Saintpaul poisoning -- including two in Michigan -- linked to certain tomatoes. Meanwhile, consumers are being encouraged to avoid raw red Source: www.macombdaily.com Fixing our food - Los Angeles Times Salmonella-contaminated tomatoes -- the latest evidence that all is not well with our food -- have not only sickened at least 228 people but unnecessarily tainted the reputation of an entire agricultural sector. As consumers recoil from all tomatoes Source: www.latimes.com FDA sees possible J&J psoriasis drug risks - Reuters UK WASHINGTON (Reuters) - An experimental psoriasis drug from Johnson & Johnson is effective at relieving symptoms but extended use may raise the risk of cancer, U.S. drug reviewers said in documents released on Friday. "Long-term use of ustekinumab may Source: uk.reuters.com Pharmavite Prepared for U.S. Food and Drug Administration's Dietary - Forbes More than 150 million Americans take dietary supplements annually, helping create a $24.1 billion industry.(1) On June 25, 2008, the U.S. Food and Drug Administration will begin enforcing Good Manufacturing Practices (GMPs) regulation for dietary Source: www.forbes.com Ahead of the Bell: FDA food safety program - Boston Globe WASHINGTON— House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Administration Source: www.boston.com FDA declares Michigan tomatoes safe to eat - Detroit News LANSING -- The government says Michigan-grown tomatoes are safe to eat. The U.S. Food and Drug Administration has determined that the state's tomatoes aren't associated with the recent outbreak of salmonella. Michigan Department of Agriculture Source: www.detnews.com 228 People in 22 States Sickened in Ongoing Salmonella-Tomato Outbreak - Atlanta Journal Constitution 228 People in 22 States Sickened in Ongoing Salmonella-Tomato Outbreak - Atlanta Journal Constitution
THURSDAY, June 12 (HealthDay News) -- The number of people sickened in the ongoing outbreak of salmonella-contaminated tomatoes has risen to 228 in 22 states, with 25 hospitalizations, U.S. health officials reported Thursday. Also Thursday Source: www.ajc.com Va. Tomato Farmers Fear Backlash - Washington Post PARKSLEY, Va. -- Here on the Eastern Shore of Virginia, tens of millions of dollars' worth of fledgling tomato plants are budding, green and healthy-looking, growing toward the July harvest. The Food and Drug Administration has declared Virginia's Source: www.washingtonpost.com Ahead of the Bell: FDA food safety program - Boston Globe WASHINGTON— House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Administration Source: www.boston.com Ahead of the Bell: FDA food safety program - CNBC WASHINGTON (AP) - House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Source: www.cnbc.com FDA finds link in salmonella cases - Boston Globe WASHINGTON - Nine people who contracted salmonella associated with raw tomatoes ate at two restaurants that are part of the same chain, according to the head of the Food and Drug Administration. The FDA commissioner, Andrew von Eschenbach, described Source: www.boston.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com FDA: Florida, Mexico suspects in tomato outbreak - Newsday WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.newsday.com Growers work to restore trust in tomatoes - Miami Herald As Sylena Reid picked up a tomato at Publix, she paused before she put it into her shopping basket. ''I hope they're safe now,'' said Reid, 30, of Hollywood. ``I can't make bruschetta without tomatoes.'' After a national salmonella outbreak had Source: www.miamiherald.com Fixing our food - Los Angeles Times Salmonella-contaminated tomatoes -- the latest evidence that all is not well with our food -- have not only sickened at least 228 people but unnecessarily tainted the reputation of an entire agricultural sector. As consumers recoil from all tomatoes Source: www.latimes.com Tainted Tomatoes Likely From Florida or Mexico: FDA - Atlanta Journal Constitution Tainted Tomatoes Likely From Florida or Mexico: FDA - Atlanta Journal Constitution
FRIDAY, June 13 (HealthDay News) -- The bulk of the tomatoes available in the United States at the start of the ongoing salmonella outbreak came from Florida and Mexico, U.S. health officials said Friday. "The vast majority of tomatoes in national Source: www.ajc.com FDA backs new tests to monitor drug safety - San Francisco Gate del.icio.us Drug regulators in the United States and Europe are encouraging pharmaceutical companies to use a set of sensitive new tests that can pick up early signs that an experimental medicine might cause kidney damage. The joint endorsement Source: www.sfgate.com Sioux Falls doctor warned by FDA about clinical trial - Argus Leader A Sioux Falls doctor has received a warning letter from the U.S. Food and Drug Administration for violations regarding how he conducted a trial for a medical device. In a four-page letter April 7 to Dr. Wilson Asfora of Sanford Clinic Neurosurgery Source: www.argusleader.com FDA: Florida, Mexico Supplied 'Majority' of Tomatoes in Outbreak - FOX News June 9: Bags of tomatoes being tested for salmonella bacteria are seen at FDA's southwest regional research lab in Irvine, Calif. WASHINGTON — Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella Source: www.foxnews.com TOMATOES AND SALMONELLA - Houston Chronicle Last week, federal officials were bombarded with questions about an outbreak of potentially deadly salmonella poisoning from tomatoes. How many people are affected? Where were these tomatoes grown? When will it be safe to eat them again? On Wednesday Source: www.chron.com FDA: JNJ Unit's Psoriasis Drug Appears Effective - CNN Money WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday said a drug from a Johnson & Johnson (JNJ) unit appears effective at treating a severe skin disease, but warned it may increase the risk of cancer. The FDA said it may need more long Source: money.cnn.com Lengthy process in FDA recall of tomatoes, other foods - Houston Chronicle We're sorry, but the article you requested is not currently available on Chron.com . If it's an older article that you had bookmarked, you may be able to find it in the archives . If you got to this page from a current link on our site, then it's an Source: www.chron.com FDA: Florida, Mexico suspects in tomato outbreak - Newsday WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.newsday.com Fixing our food - Los Angeles Times Salmonella-contaminated tomatoes -- the latest evidence that all is not well with our food -- have not only sickened at least 228 people but unnecessarily tainted the reputation of an entire agricultural sector. As consumers recoil from all tomatoes Source: www.latimes.com FDA: Florida, Mexico suspects in tomato outbreak - Newsday FDA: Florida, Mexico suspects in tomato outbreak - Newsday
WASHINGTON - Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.newsday.com FDA: Florida, Mexico Supplied 'Majority' of Tomatoes in Outbreak - FOX News June 9: Bags of tomatoes being tested for salmonella bacteria are seen at FDA's southwest regional research lab in Irvine, Calif. WASHINGTON — Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella Source: www.foxnews.com FDA declares Mich. tomatoes safe to eat - Detroit Free Press The government says Michigan-grown tomatoes are safe to eat. The U.S. Food and Drug Administration has determined that the state’s tomatoes aren’t associated with the recent outbreak of salmonella. Michigan Department of Agriculture Director Don Source: www.freep.com FDA: Florida, Mexico suspects in tomato outbreak - Herald Tribune WASHINGTON — Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its Source: www.heraldtribune.com FDA hit over safety failure - Baltimore Sun WASHINGTON - As the government struggles to trace another bacterial outbreak, this time in tomatoes, congressional investigators are attacking federal health officials for failing to follow up on recent promises to improve food safety. The Salmonella Source: www.baltimoresun.com Va. Tomato Farmers Fear Backlash - Washington Post Gary Stewart, general manager of Byrd Foods, surveys his tomato fields on Virginia's Eastern Shore. Harvest will commence after the Fourth of July, and growers hope consumer confidence in tomatoes has rebounded by then. (By Alejandro Lazo -- The Source: www.washingtonpost.com FDA: Parts of Florida, Mexico still suspects in tomato outbreak - Grand Forks Herald Parts of Florida and Mexico were supplying "the vast majority" of tomatoes sold when the salmonella outbreak began in April and thus remain leading suspects, the Food and Drug Administration said Friday. But the FDA hasn't narrowed its hunt to just Source: www.grandforksherald.com Ahead of the Bell: FDA food safety program - Boston Globe WASHINGTON— House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Administration Source: www.boston.com FDA sees possible J&J psoriasis drug risks - Reuters UK WASHINGTON (Reuters) - An experimental psoriasis drug from Johnson & Johnson is effective at relieving symptoms but extended use may raise the risk of cancer, U.S. drug reviewers said in documents released on Friday. "Long-term use of ustekinumab may Source: uk.reuters.com June 13, 2008Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 60 mg Extended Release Tablets
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Pregnant Women to Benefit from Better Information Pregnant Women to Benefit from Better Information
A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets (June 9) ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 60 mg Extended Release Tablets
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA investigating TNF blockers and cancer risk in children and young adults. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Emergency Filtration Products Submits 510(k) Pre-Market Notification - MSN MoneyCentral Emergency Filtration Products Submits 510(k) Pre-Market Notification - MSN MoneyCentral
Emergency Filtration Products, Inc. (EFP) (PINKSHEETS: EMFP) announced that earlier today it had filed a 510(k) pre-market notification with the U.S. Food and Drug Administration (FDA) for its NanoMask(TM). The process, timing and results of any FDA Source: news.moneycentral.msn.com Source of salmonella-tainted tomatoes may remain a mystery, FDA says - Los Angeles Times Federal officials said Thursday that they might never learn which farms produced tainted tomatoes that have now sickened 228 people in 23 states with a rare form of salmonella. "At this stage of the investigation there is no guarantee that we will be Source: www.latimes.com PreMD Reports Further Positive Meetings with the FDA - Forbes TORONTO, June 13 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced that the Company has had further meetings with the U.S. Food and Drug Administration (FDA) in an effort to resolve the outstanding Source: www.forbes.com US FDA staff sees J&J psoriasis drug risks - Reuters WASHINGTON, June 13 (Reuters) - An experimental psoriasis drug from Johnson & Johnson (JNJ.N: Quote , Profile , Research , Stock Buzz ) was effective in clinical trials, but long-term use may increase the risk of cancer, U.S. drug reviewers said in Source: www.reuters.com FDA warns of mercury in fillings - Seattle Times WASHINGTON — Silver dental fillings contain mercury, and the government for the first time is warning they might pose a safety concern for pregnant women and young children. The Food and Drug Administration (FDA) posted the precaution on its Web Source: seattletimes.nwsource.com Silver's risky for some smiles, FDA says - San Francisco Gate Silver dental fillings contain mercury, and the government is warning for the first time that they may pose a health concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site this month to Source: www.sfgate.com Tomato salmonella illnesses rise - Miami Herald The toll from salmonella-tainted tomatoes jumped to 228 illnesses Thursday as the government learned of five dozen previously unknown cases and said it is possible the food poisoning contributed to a cancer patient's death. Six more states -- Florida Source: www.miamiherald.com Don't drink raw milk, FDA warns - Orlando Sentinel SAN FRANCISCO - Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who think it contains beneficial microbes that treat everything from asthma to autism. The unpasteurized milk swiftly caught on as part of the growing Source: www.orlandosentinel.com FDA backs New York City in dispute over calories on menus - Arizona Daily Star NEW YORK — The Food and Drug Administration believes the city has a right to force chain restaurants to post calorie counts on menu boards, a government lawyer told a federal appeals court on Thursday, but the court did not immediately decide Source: www.azstarnet.com Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28)
Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. June 12, 2008Albuterol Inhalers: Time to Transition Albuterol Inhalers: Time to Transition
Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Lawmakers subpoena 9 food testing companies - MSNBC Lawmakers subpoena 9 food testing companies - MSNBC
WASHINGTON - Lawmakers voted Thursday to subpoena nine companies responsible for analyzing the most dangerous food entering the country as part of an investigation that gained more urgency with an outbreak of salmonella from tomatoes. For months, a Source: www.msnbc.msn.com State: Feds clear Florida's tomatoes in salmonella scare - Herald Tribune TALLAHASSEE, Fla. — The U.S. Food and Drug Administration has put Florida on its safe list for tomatoes. Commissioner Andrew von Eschenbach said Tuesday night the agency hopes to identify the source of a nationwide salmonella outbreak linked to Source: www.heraldtribune.com FDA hit for slow progress on improving food safety - Guardian Unlimited WASHINGTON, June 12 (Reuters) - U.S. health officials have not followed through on a promise made last year to make the food supply safer, lawmakers and others said on Thursday, as investigators probed the latest foodborne illness. In the past week Source: www.guardian.co.uk UPDATE 2-FDA hit for slow progress on improving food safety - Reuters UPDATE 2-FDA hit for slow progress on improving food safety - Reuters
WASHINGTON, June 12 (Reuters) - U.S. health officials have not made good on their promise last year to make food safer, lawmakers and others said on Thursday, as investigations widened to find the source of the latest outbreak of Salmonella that has Source: www.reuters.com FDA issues precautionary note on silver fillings - Forbes Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site earlier this Source: www.forbes.com Source of tainted tomatoes may remain a mystery, FDA says - Los Angeles Times Federal officials said Thursday that they might never learn which farms produced tainted tomatoes that have now sickened 228 people in 23 states with a rare form of salmonella. "At this stage of the investigation there is no guarantee that we will be Source: www.latimes.com Food Safety Plan by U.S. FDA Lacks Costs, Timeline (Update2) - Bloomberg June 12 (Bloomberg) -- The U.S. Food and Drug Administration has failed to provide costs or deadlines for a plan to improve food safety even as tainted tomatoes have sickened Americans, according to a report to Congress. The agency oversees the Source: www.bloomberg.com FDA backs NYC in dispute over calories on menus - MSN MoneyCentral NEW YORK (AP) - The Food and Drug Administration believes the city has a right to force chain restaurants to post calorie counts on menu boards, a government lawyer told a federal appeals court on Thursday, but the court did not immediately decide Source: moneycentral.msn.com GE Healthcare says FDA OKs AdreView application for priority review - CNBC SAN FRANCISCO (Thomson Financial) - General Electric Co.'s GE Healthcare said Thursday the Food and Drug Administration has accepted its AdreView application for priority review. AdreView is a molecular imaging agent for the detection of Source: www.cnbc.com UPDATE 3-US senator seeks FDA probe of Glaxo's Paxil data - Reuters WASHINGTON, June 12 (Reuters) - U.S. Sen. Charles Grassley asked regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc (GSK.L: Quote , Profile , Research )(GSK.N: Quote , Profile , Research ) withheld data about a risk of Source: www.reuters.com U.S. mulls private drug checks despite device lessons - San Diego Union-Tribune U.S. mulls private drug checks despite device lessons - San Diego Union-Tribune
WASHINGTON – U.S. health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar program to inspect foreign-made medical devices has largely floundered. On Monday, Food Source: www.signonsandiego.com Salmonella found in tomatoes affects Iowa restaurants - U-Wire.com Hold the tomato. Local businesses are feeling the effects of a warning issued by the Food and Drug Administration, which has caused restaurants and grocery stores to tweak their menus and offerings. Iowa is still being investigated as a potential Source: www.uwire.com ANALYSIS-US mulls private drug checks despite device lessons - Forbes WASHINGTON (Reuters) - U.S. health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar program to inspect foreign-made medical devices has largely floundered. On Monday Source: www.forbes.com Teva wins tentative FDA approval for drug - CNBC NEW YORK - Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. said Thursday the U.S. Food and Drug Administration tentatively approved the company's application to market a generic version of hypertension drug Diovan. The company said Source: www.cnbc.com Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12)
Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. Glaxo: 4 million people tried diet drug since launch - Dallas Morning News Glaxo: 4 million people tried diet drug since launch - Dallas Morning News
GlaxoSmithKline said Wednesday that 4 million people have tried alli since the drug hit shelves a year ago. Alli is the only nonprescription weight loss pill approved by the Food and Drug Administration. Source: www.dallasnews.com June 2008 Patient Safety News June 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Lake Country Lamb Feed Voluntary Recall (June 6) Lake Country Lamb Feed Voluntary Recall (June 6)
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... Ahead of the Bell: FDA food safety program - CNN Money Ahead of the Bell: FDA food safety program - CNN Money
NEW YORK (Associated Press) - House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Source: money.cnn.com FDA hit over safety failure - Baltimore Sun WASHINGTON - As the government struggles to trace another bacterial outbreak, this time in tomatoes, congressional investigators are attacking federal health officials for failing to follow up on recent promises to improve food safety. The Salmonella Source: www.baltimoresun.com Ahead of the Bell: FDA food safety program - Boston Globe WASHINGTON— House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Administration Source: www.boston.com Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in - MSN MoneyCentral WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation RGEN today announced that based on feedback from the Food and Drug Administration, the Company plans to initiate a Phase 2b clinical trial of RG2417, an oral formulation of Source: news.moneycentral.msn.com Barr sued for alleged patent infringement - Forbes Barr Pharmaceuticals Inc. said Tuesday it is being sued by Japan-based Takeda Pharmaceutical Co. and TAP Pharmaceuticals Inc. for alleged patent infringement of a patent covering the antacid Prevacid. Barr asked the Food and Drug Administration to Source: www.forbes.com Molecular Insight Pharmaceuticals, Inc. Initiates Trofex(TM) Phase 1 - MSN MoneyCentral Molecular Insight Pharmaceuticals, Inc. MIPI announced today that it has initiated a Phase 1 clinical trial for its Trofex molecular imaging program for the detection and staging of metastatic prostate cancer. The trial is designed to investigate two Source: news.moneycentral.msn.com FDA Expands Tomato Warning Nationwide - Atlanta Journal Constitution FDA Expands Tomato Warning Nationwide - Atlanta Journal Constitution
TUESDAY, June 10 (HealthDay News) -- U.S. health officials expanded their warning about salmonella-contaminated tomatoes nationwide Tuesday, as experts cautioned consumers to employ a little detective work and forgo certain types of tomatoes for the Source: www.ajc.com FDA, Pfizer Told of Chantix Safety Concerns a Year Ago - ABC News A physician and top smoking cessation researcher says U.S. regulators and a drugmaker brushed aside his concerns a year ago about possibly dangerous side effects from longer-term use of the stop-smoking drug Chantix. One smoking cessation expert says Source: www.abcnews.go.com FDA still hunting source of salmonella in tomatoes - Goshen News WASHINGTON (AP) — Federal health officials haven’t yet traced the source of salmonella-tainted tomatoes but, amid an outcry from farmers, are clearing innocent crops as fast as possible. “We’re getting very close” to identifying the Source: www.goshennews.com FDA Cracks Down on Unpasteurized Milk - FOX News SAN FRANCISCO — Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who believe it contains beneficial microbes that treat everything from asthma to autism. The unpasteurized milk swiftly caught on as part of the Source: www.foxnews.com Ala. laser maker in trouble with FDA - Birmingham News BIRMINGHAM, Ala. (AP) — A small Birmingham company is in trouble with the Food and Drug Administration over the lasers it makes for cosmetic surgery. The FDA has cited Sandstone Medical Technologies for what it calls significant violations of Source: www.al.com Tomato Contamination Cases Are Being Reported Daily (Update1) - Bloomberg June 12 (Bloomberg) -- New infections are being reported daily from the outbreak of tainted tomatoes that has sickened at least 167 people in the U.S., an official with the Centers for Disease Control and Prevention said. ``We are still seeing cases Source: www.bloomberg.com Barr sued for alleged patent infringement - Forbes Barr sued for alleged patent infringement - Forbes
Barr Pharmaceuticals Inc. said Tuesday it is being sued by Japan-based Takeda Pharmaceutical Co. and TAP Pharmaceuticals Inc. for alleged patent infringement of a patent covering the antacid Prevacid. Barr asked the Food and Drug Administration to Source: www.forbes.com Ahead of the Bell: FDA food safety program - Boston Globe WASHINGTON— House Democrats on Thursday are expected to use worries over salmonella-infected tomatoes to bolster their calls for tougher food safety measures. A House Energy and Commerce subcommittee will scrutinize the Food and Drug Administration Source: www.boston.com Food Safety Plan by U.S. FDA Lacks Cost Estimate, Deadlines - Bloomberg June 12 (Bloomberg) -- The U.S. Food and Drug Administration has failed to provide costs or deadlines for a plan to improve food safety even as tainted tomatoes have sickened Americans, according to a report to Congress. The agency oversees the Source: www.bloomberg.com Business Briefing: Salmonella, Raw Milk, Airline Surcharge, Sripps - The Ledger Federal health officials haven't yet traced the source of salmonella-tainted tomatoes but, amid an outcry from farmers, are clearing innocent crops as fast as possible. "We're getting very close' to identifying the outbreak's source," Dr. David Source: www.theledger.com Glaxo: 4 Million Have Tried Alli Weight Loss Drug - FOX News NEW YORK — The only over-the-counter, federally approved weight loss pill in the U.S. isn't exactly flying off shelves, but it's not because Americans are getting any slimmer. GlaxoSmithKline said Wednesday that 4 million people have tried alli Source: www.foxnews.com FDA, Pfizer Told of Chantix Safety Concerns a Year Ago - ABC News A physician and top smoking cessation researcher says U.S. regulators and a drugmaker brushed aside his concerns a year ago about possibly dangerous side effects from longer-term use of the stop-smoking drug Chantix. One smoking cessation expert says Source: www.abcnews.go.com Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in - MSN MoneyCentral WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation RGEN today announced that based on feedback from the Food and Drug Administration, the Company plans to initiate a Phase 2b clinical trial of RG2417, an oral formulation of Source: news.moneycentral.msn.com GPC wins European patent for satraplatin in taxane-resistant cancer - CNBC (Adds background) MARTINSRIED, Germany (Thomson Financial) - GPC Biotech AG. said it won a European patent for its experimental cancer drug satraplatin when used in prostate cancer patients who could not be helped by taxane-based chemotherapy, as it Source: www.cnbc.com FDA warns Birmingham cosmetic laser company - Birmingham News FDA warns Birmingham cosmetic laser company - Birmingham News
The FDA has cited a Birmingham cosmetic laser company for numerous violations of manufacturing regulations, according to a warning letter released Wednesday. Sandstone Medical Technologies, LLC, with offices and facilities located at 102 Oxmoor Road Source: www.al.com Tomato Contamination Cases Are Being Reported Daily, U.S. Says - Bloomberg June 12 (Bloomberg) -- New infections are being reported daily from the outbreak of tainted tomatoes that has sickened at least 167 people in the U.S., an official with the Centers for Disease Control and Prevention said. ``We are still seeing cases Source: www.bloomberg.com FDA Expands Tomato Warning Nationwide - Atlanta Journal Constitution TUESDAY, June 10 (HealthDay News) -- U.S. health officials expanded their warning about salmonella-contaminated tomatoes nationwide Tuesday, as experts cautioned consumers to employ a little detective work and forgo certain types of tomatoes for the Source: www.ajc.com FDA still investigating - Biloxi Sun Herald Federal health officials haven't yet traced the source of salmonella-tainted tomatoes but, amid an outcry from farmers, are clearing innocent crops as fast as possible. "We're getting very close" to identifying the outbreak's source, Dr. David Source: www.sunherald.com FDA HIT over safety failure - Baltimore Sun WASHINGTON - As the government struggles to trace another bacterial outbreak, this time in tomatoes, congressional investigators are attacking federal health officials for failing to follow up on recent promises to improve food safety. The Salmonella Source: www.baltimoresun.com FDA cracks down on sellers of raw milk - Arizona Daily Star SAN FRANCISCO — Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who believe it contains beneficial microbes that treat everything from asthma to autism. The unpasteurized milk swiftly caught on as part of the Source: www.azstarnet.com FDA Officials Crack Down On Dairy, Raw Milk Craze - Tampa Bay Online SAN FRANCISCO - Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who believe it contains beneficial microbes that treat everything from asthma to autism. The unpasteurized milk swiftly caught on as part of the Source: www2.tbo.com June 11, 2008FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Controlling Cholesterol with Statins Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Warning on Certain Types of Raw Red Tomatoes Warning on Certain Types of Raw Red Tomatoes
FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. FDA still seeking source of contaminated tomatoes - Chicago Tribune FDA still seeking source of contaminated tomatoes - Chicago Tribune
The U.S. Food and Drug Administration is struggling to find the source of contaminated tomatoes that may be tied to 23 hospitalizations, as lawmakers question the agency's response. The tomatoes must be traced back from stores to distributors to Source: www.chicagotribune.com US review: Suicidal actions linked with epilepsy drugs - Forbes WASHINGTON (Reuters) - Epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior, U.S. drug reviewers said in an analysis that was released Wednesday and mirrored earlier findings. "The effect appears consistent among the Source: www.forbes.com UPDATE 2-FDA has tomato Salmonella reports in 17 states - Reuters LOS ANGELES, June 11 (Reuters) - U.S. health officials said on Wednesday they are still receiving reports of people falling ill from eating Salmonella-tainted tomatoes and that they now have 167 reported cases from 17 states. Representatives from the Source: www.reuters.com Review finds suicidal actions linked with epilepsy drugs - Reuters UK WASHINGTON (Reuters) - Epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior, U.S. drug reviewers said in an analysis that was released on Wednesday and mirrored earlier findings. "The effect appears consistent among the Source: uk.reuters.com Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA investigating TNF blockers and cancer risk in children and young adults. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Controlling Cholesterol with Statins Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets (June 9) ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Specter Says Bush Administration Is Hindering Quick FDA Funding - Wall Street Journal Specter Says Bush Administration Is Hindering Quick FDA Funding - Wall Street Journal
WASHINGTON -- Sen. Arlen Specter said the Bush administration is "drastically hindering" the Food and Drug Administration's ability to quickly get an important boost in funding. In a letter sent Tuesday to Health and Human Services Secretary Michael Source: online.wsj.com Health officials crack down on unpasteurized milk - Kansas City Star Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who believe it contains beneficial microbes that treat everything from asthma to autism. The unpasteurized milk swiftly caught on as part of the growing natural food Source: www.kansascity.com Correction: McDonald's-Tomatoes story - Kansas City Star In a June 9 story about an outbreak of salmonella linked to tomatoes at chain restaurants, The Associated Press erroneously described the policy of McDonald's Corp., which has stopped using sliced tomatoes as a precaution. McDonald's said it will Source: www.kansascity.com Florida Counties Poised to Begin Shipping Tomatoes Again after Being - Forbes Florida Counties Poised to Begin Shipping Tomatoes Again after Being - Forbes
Florida's tomato growers enthusiastically welcomed the U.S. Food and Drug Administration's announcement that consumers are clear to eat tomatoes harvested in 19 Florida counties. The counties encompass the Ruskin-Palmetto and Quincy areas of the Source: www.forbes.com FDA: Plastic Baby, Water Bottles Are Safe - FOX News The National Toxicology Program said in a recent draft report that there is "some concern" that bisphenol A can cause changes in behavior and the brain, as well as reduce survival and birthweight in fetuses. It drew its conclusions from animal Source: www.foxnews.com Xiadafil VIP Tablets Xiadafil VIP Tablets
Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. India's Lupin gets U.S. FDA nod to market ramipril - Reuters India's Lupin gets U.S. FDA nod to market ramipril - Reuters
MUMBAI, June 11 (Reuters) - Indian drug maker Lupin Ltd (LUPN.BO: Quote , Profile , Research ) said on Wednesday it had approval from the U.S. Food and Drug Administration to market ramipril capsules in multiple strengths. The drug, used to treat Source: www.reuters.com Centocor arthritis drug meets goal in 3 trials - CNN Money NEW YORK (Associated Press) - Centocor Inc. said Wednesday an injectable drug to treat a type of arthritic pain met its goal in three late-stage trials. The company said more patients given golimumab in addition to methotrexate achieved an Source: money.cnn.com Durect submits new drug application for Remoxy - Boston Globe CUPERTINO, Calif.— Drug developer Durect Corp. said Tuesday it applied for regulatory approval of Remoxy, designed to be an abuse-resistant form of oxycodone. The company submitted a new drug application to the U.S. Food and Drug Administration to Source: www.boston.com Tomato warning expands in Salmonella scare - Houston Chronicle The federal government on Tuesday expanded its salmonella warning nationwide about three kinds of tomatoes as more retailers and restaurants stopped offering them and growers said sales are plummeting. Officials at the U.S. Food and Drug Source: www.chron.com FDA closing in on source of tomato outbreak - MSNBC SAN FRANCISCO - U.S. Food and Drug Administration Commissioner Andrew von Eschenbach says the agency hopes to identify the source of a nationwide salmonella outbreak linked to tomatoes “in the next few days.” Speaking at the Commonwealth Club in Source: www.msnbc.msn.com Unichem Labs gets US nod for zaleplon capsules - Reuters India MUMBAI, June 11 (Reuters) - Drug maker Unichem Laboratories Ltd (UNLB.BO: Quote , Profile , Research ) said on Wednesday it received the U.S. Food and Drug Administration approval for sale of insomnia drug, zaleplon, in capsule form. The drug is the Source: in.reuters.com Mylan gets FDA approval to market generic Sonata - CNN Money NEW YORK (Associated Press) - Mylan Inc. said Monday the Food and Drug Administration approved the company's application to sell generic capsules of Sonata, an insomnia treatment. The company will immediately begin shipping Zaleplon capsules in 5 and Source: money.cnn.com F.D.A. Reports Progress in Tracing Salmonella - New York Times WASHINGTON — Federal health officials said Tuesday that they hoped to announce soon the source of a salmonella outbreak associated with raw tomatoes that has sickened at least 167 people in 17 states and led restaurants and grocery stores to remove Source: www.nytimes.com Why did food sellers treat tomatoes like hot potatoes? - Newsday ATLANTA - It's the beginning of the summer, and it's tough to find fresh salsa for our chips and tomatoes for our burgers. But experts say supermarkets and fast food chains that threw out tomatoes suspected in a salmonella outbreak were acting Source: www.newsday.com Why did food sellers treat tomatoes like hot potatoes? - CNBC Why did food sellers treat tomatoes like hot potatoes? - CNBC
ATLANTA (AP) - 0609dv--ca--salmonella--tomatoes It's the beginning of the summer, and it's tough to find fresh salsa for our chips and tomatoes for our burgers. But experts say supermarkets and fast food chains that threw out tomatoes suspected in a Source: www.cnbc.com FDA Starts Safety Review of Autoimmune Disorder Drugs - Atlanta Journal Constitution WEDNESDAY, June 4 (HealthDay News) -- U.S. health officials have started a safety review of a class of drugs known as tumor necrosis factor (TNF) blockers, which are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis Source: www.ajc.com India's Lupin gets final FDA approval for Ramipril hypertension drug - Forbes MUMBAI (Thomson Financial) - India's Lupin Ltd. said the U.S. Food and Drug Administration has granted final approval for the company's abbreviated new drug application to sell hypertension drug Ramipril in capsules. Dosage strengths of 1.25 Source: www.forbes.com Bush administration seeks more money to provide protection on food - International Herald Tribune Bush administration seeks more money to provide protection on food - International Herald Tribune
WASHINGTON : The Food and Drug Administration on Monday night asked Congress for an additional $275 million for import protection, following a spate of criticism that the agency is trying to do too much with too few resources. The money would hire an Source: www.iht.com Unichem Labs gets US nod for zaleplon capsules - Reuters India MUMBAI, June 11 (Reuters) - Drug maker Unichem Laboratories Ltd (UNLB.BO: Quote , Profile , Research ) said on Wednesday it received the U.S. Food and Drug Administration approval for sale of insomnia drug, zaleplon, in capsule form. The drug is the Source: in.reuters.com June 10, 2008Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30)
Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Bayer Removes Remaining Trasylol Stock Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. June 2008 Patient Safety News June 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Here Comes the Sun. So Watch Out - BusinessWeek Here Comes the Sun. So Watch Out - BusinessWeek
For those seeking sun protection this summer, Peter Thomas Roth has given new meaning to the phrase "take a powder." "Some people just don't want to put lotion on their faces," says Roth, founder and chief executive officer of Peter Thomas Roth Source: www.businessweek.com FDA expands red tomato warning due to salmonella - Xinhua News Agency WASHINGTON, June 10 (Xinhua) -- The U.S. Food and Drug Administration (FDA) announced on Tuesday to expand its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, raw red Roma, raw red Source: news.xinhuanet.com FDA official says baby bottles with bisphenol A safe - BusinessWeek Plastic baby bottles and water bottles are safe, a federal health official said Tuesday, seeking to ease public concerns about the health hazards of a chemical used in the products. The National Toxicology Program said in a recent draft report that Source: www.businessweek.com Florida tomatoes now on FDA 'safe list,' state says - Palm Beach Post The U.S. Food and Drug Administration has determined that Florida-grown tomatoes are not involved in the 17-state salmonella outbreak, and have placed them on the "safe to eat" list, state Agriculture Commissioner Charles Bronson said today. The FDA Source: www.palmbeachpost.com Salmonella Alert Jeopardizes $40 Mil. in Fla. Tomatoes - The Ledger LAKELAND | Produce shippers are sitting on $40 million of Florida tomatoes that could be lost unless federal officials clear them soon of any link to a salmonella outbreak in the western U.S. "The fact that the FDA (U.S. Food and Drug Administration Source: www.theledger.com Your Guide to Reporting Problems to FDA Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA. Advanced Medical Optics Presents to the U.S. Food and Drug - MSN MoneyCentral Advanced Medical Optics Presents to the U.S. Food and Drug - MSN MoneyCentral
Advanced Medical Optics (AMO) EYE today announced its continued support and cooperation with the U.S. Food and Drug Administration (FDA) regarding the enhancement of product safety and effectiveness of contact lens care products. AMO ’ s Source: news.moneycentral.msn.com Salmonella Alert Jeopardizes $40 Mil. in Fla. Tomatoes - The Ledger LAKELAND | Produce shippers are sitting on $40 million of Florida tomatoes that could be lost unless federal officials clear them soon of any link to a salmonella outbreak in the western U.S. "The fact that the FDA (U.S. Food and Drug Administration Source: www.theledger.com FDA official says baby bottles with bisphenol A safe - BusinessWeek Plastic baby bottles and water bottles are safe, a federal health official said Tuesday, seeking to ease public concerns about the health hazards of a chemical used in the products. The National Toxicology Program said in a recent draft report that Source: www.businessweek.com FDA Inaction to Blame for Salmonella Outbreak - Common Dreams WASHINGTON, DC - June 10 - The Food and Drug Administration deserves any rotten tomatoes thrown its way in the wake of this latest outbreak. Since 2006, CSPI has been urging FDA to require all farms that feed the American public to have written food Source: www.commondreams.org North America tomato industry reeling-growers - Forbes United States - (Updates with FDA clearing Florida tomatoes) By Jane Sutton MIAMI (Reuters) - Tomato growers in Florida, California and Mexico are having trouble selling their crops as U.S. regulators hunt the source of a salmonella outbreak linked Source: www.forbes.com FDA wants stricter contact lens labeling - AZCentral.com WASHINGTON - Eye care experts on Tuesday recommended sterner labeling and more thorough testing of contact lens solutions to prevent eye infections. A Food and Drug Administration panel of experts endorsed a host of changes to lens products Source: www.azcentral.com FDA: Louisiana Tomatoes Safe - WDSU NEW ORLEANS -- The recent outbreak of salmonella linked to tainted produce is a nightmare for the tomato industry as a whole, but not for growers in Louisiana. Crops grown here have not been connected in any way to the illnesses reported in at least Source: www.wdsu.com New Drug Application Submitted for Remoxy(TM) (ORADUR(TM)-Based - MSN MoneyCentral New Drug Application Submitted for Remoxy(TM) (ORADUR(TM)-Based - MSN MoneyCentral
CUPERTINO, Calif., June 10 /PRNewswire-FirstCall/ -- DURECT Corporation DRRX announced today that a New Drug Application (NDA) for Remoxy(TM) (ORADUR(TM)-based oxycodone) has been submitted to the U.S. Food and Drug Administration (FDA). Remoxy, an Source: news.moneycentral.msn.com Advanced Medical Optics Presents to the U.S. Food and Drug - MSN MoneyCentral Advanced Medical Optics (AMO) EYE today announced its continued support and cooperation with the U.S. Food and Drug Administration (FDA) regarding the enhancement of product safety and effectiveness of contact lens care products. AMO ’ s Source: news.moneycentral.msn.com Use rub-and-rinse contact lens cleaners, FDA advisers urge - Dallas Morning News Use rub-and-rinse contact lens cleaners, FDA advisers urge - Dallas Morning News
No-rub contact lens solutions made by Alcon Inc. and Bausch & Lomb Inc. may not clean as well as a rub-and-rinse routine, a U.S. panel said. Companies should tell consumers to rub their lenses with the cleaning solutions to remove germs, outside Source: www.dallasnews.com FDA Announces New Labeling Changes For Regranex - eMaxHealth.com FDA announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the Source: www.emaxhealth.com Amylin shares recover on diabetes drug data - Forbes Amylin shares recover on diabetes drug data - Forbes
Positive study data on Amylin Pharmaceuticals Inc.'s long-acting version of diabetes drug Byetta helped shares recover Tuesday, following a prior-day decline on competitive concerns. The stock gained $1.09, or 4 percent, to $27.90 in afternoon Source: www.forbes.com Big Boy Restaurants Removes Tomatoes from its Menu in Compliance with - Forbes WARREN, Mich., June 10 /PRNewswire/ -- Due to a nationwide tomato alert issued by the Food and Drug Administration, Big Boy Restaurants International LLC has ceased serving tomatoes at all of its Big Boy restaurants until further notice. "We are Source: www.forbes.com Democrats weigh banning chemical in food packaging - CNBC WASHINGTON - Some Democratic lawmakers pushed Tuesday for a ban on a chemical used in water bottles, canned food and other household items, despite mixed opinions from government experts about the substance's possible risks. Bisphenol A has been used Source: www.cnbc.com Florida tomato growers get all-clear in health scare - St. Petersburg Times Story Tools Florida's tomatoes received the all-clear mid Tuesday from the Food and Drug Administration, averting a costly crisis in the $500-million industry. Since the weekend, the state's tomato growers and packers have been in a state of Source: www.tampabay.com Ohio Tomatoes Cleared by U.S. Food and Drug Administration - Oxford Press REYNOLDSBURG — The U.S. Food and Drug Administration (FDA) has added Ohio to a list of states that are not associated with the latest food safety alert for certain types of raw red tomatoes and products containing raw red tomatoes, due to an Source: www.oxfordpress.com MainStreet.com: Grow Your Own Tomatoes - Street.Com Tomatoes are off the menu at fast food restaurants including McDonald's MCD , Burger King BKC and Yum! Brands' YUM Taco Bell, and stores such as Wal-Mart WMT , after the Food and Drug Administration expanded its warning on June 9 against a rare form Source: www.thestreet.com Louisiana tomatoes get thumbs-up from FDA - News-Star Louisiana tomatoes get thumbs-up from FDA - News-Star
The U.S. Food and Drug Administration has put Louisiana on its list of states with safe-to-eat tomatoes. Louisiana Agriculture and Forestry Commissioner Mike Strain said he asked the FDA to include Louisiana on the list after supermarket chains Source: www.thenewsstar.com FDA seeks increased funding for food safety - Washington Post FDA seeks increased funding for food safety - Washington Post
Resize Text WASHINGTON (Reuters) - The Bush administration is asking Congress for an increase of $275 million above its current budget request to enhance federal food safety programs, U.S. Health Secretary Michael Leavitt said on Monday. The White Source: www.washingtonpost.com Cardinal Alcohol-Free Mouthwash Cardinal Alcohol-Free Mouthwash
Additional lot recalled because of the presence of Burkholderia cepacia. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Florida tomato industry in 'complete collapse' - Forbes Florida tomato industry in 'complete collapse' - Forbes
MIAMI (Reuters) - Florida's tomato industry is in "complete collapse" and $40 million worth of tomatoes will rot unless federal regulators quickly trace the source of a salmonella outbreak and clear the state's produce, an industry official said Source: www.forbes.com Salmonella Alert Jeopardizes $40 Mil. in Fla. Tomatoes - The Ledger LAKELAND | Produce shippers are sitting on $40 million of Florida tomatoes that could be lost unless federal officials clear them soon of any link to a salmonella outbreak in the western U.S. "The fact that the FDA (U.S. Food and Drug Administration Source: www.theledger.com Tomato outbreak is reminder to follow these food safety tips and avoid - Minneapolis Star Tribune EU summit is Bush's first stop in Europe Report: Rare chicken's numbers on the decline EU summit is Bush's first stop in Europe Flash floods inundate Wis. town for 2nd time The Nation's Weather ` A salmonella outbreak linked to raw tomatoes serves as Source: www.startribune.com Pain Therapeutics and King Pharmaceuticals Announce Submission of New - MSN MoneyCentral SAN MATEO, Calif. and BRISTOL, Tenn., June 10, 2008 (PRIME NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) and King Pharmaceuticals, Inc. (NYSE:KG) today announced that a New Drug Application (NDA) for Remoxy(tm) has been submitted to the U.S Source: news.moneycentral.msn.com Tomato outbreak is reminder to think food safety - Forbes A salmonella outbreak linked to raw tomatoes serves as a reminder to take extra care with summer fruits and vegetables. More than 20 people have been hospitalized as the government investigates the source of the tomatoes responsible for the illnesses Source: www.forbes.com Groceries, eateries tossing suspect tomatoes - San Francisco Gate Major U.S. supermarket and restaurant chains are pulling selected stocks of fresh tomatoes in the outbreak of salmonella poisoning that investigators say may have originated in imports from Mexico. At least 145 people in 16 states - including one Source: www.sfgate.com Tomatoes Off Menus Amid Salmonella Outbreak - NPR News NPR.org , June 10, 2008 · McDonald's "Big N' Tasty" sandwich is a little smaller Tuesday, and the Chicken Ranch BLT has temporarily lost its "T." Tomatoes are under scrutiny as the possible culprit in a salmonella outbreak that has sickened at least Source: www.npr.org FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Requests Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. New Type of Latex Glove Cleared FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Salmonella Alert Jeopardizes $40 Mil. in Fla. Tomatoes - The Ledger Salmonella Alert Jeopardizes $40 Mil. in Fla. Tomatoes - The Ledger
LAKELAND | Produce shippers are sitting on $40 million of Florida tomatoes that could be lost unless federal officials clear them soon of any link to a salmonella outbreak in the western U.S. "The fact that the FDA (U.S. Food and Drug Administration Source: www.theledger.com Business briefing - Los Angeles Times Michael J. Ellis, the founder and former president of dietary supplement maker Metabolife International Inc., was sentenced to six months in prison and ordered to pay a $20,000 fine for lying to the U.S. Food and Drug Administration. Ellis pleaded Source: www.latimes.com Bush seeks $275 million more for the FDA - Baltimore Sun WASHINGTON - President Bush abruptly proposed yesterday a significant increase in government funding to ensure the safety of food and drug imports. The Bush administration requested giving the Food and Drug Administration an added $275million in Source: www.baltimoresun.com Bush Seeks $275 Million More to Improve U.S. Food, Drug Safety - Bloomberg June 10 (Bloomberg) -- The Bush administration increased its budget request for the U.S. Food and Drug Administration by $275 million after the agency's commissioner told Congress that more funding was needed to protect against unsafe products. The Source: www.bloomberg.com Grocers and Restaurants Toss Out Tomatoes - Wall Street Journal Restaurants and supermarkets across the country pulled certain fresh tomatoes from their menus and produce aisles in response to concerns about a recent spate of salmonella cases, delivering a serious blow to the nation's tomato growers. Fast-food Source: online.wsj.com Congress wary of plastics used in toys, bottles - Boston Globe WASHINGTON— Chemicals used in baby bottles, toys and thousands of other household items are getting closer scrutiny from lawmakers amid concern they can cause developmental problems in children. A House Energy and Commerce Subcommittee meets Source: www.boston.com Tomato recall includes safe list - Seattle Post Intelligencer Tomato recall includes safe list - Seattle Post Intelligencer
Produce managers at most of the nation's grocery chains spent the last two days removing potentially dangerous tomatoes from the shelves and posting signs telling shoppers that what they were still selling was, according to the Food and Drug Source: seattlepi.nwsource.com Salmonella outbreak causes local tomato worries - News-Star A warning from the US Food and Drug Administration has prompted Taco Bell restaurants to make the decision to temporarily remove tomatoes from all of its menu items. The Food and Drug Administration warning to consumers resulted from an outbreak of Source: www.thenewsstar.com Aurobindo Pharma gets FDA nod for Zaleplon generic insomnia capsules - CNBC MUMBAI (Thomson Financial) - India's Aurobindo Pharma Ltd. said it received a final approval from the U.S. Food and Drug Administration to manufacture and market Zaleplon capsules. The company said the capsules are the generic equivalent of King Source: www.cnbc.com Quotations of the day - Charleston Gazette "I just laughed. It's easier than crying.'' -- Tony Kelbel, a Wisconsin businessman who had to throw out ruined food and sweep out inch-thick mud after Midwest flooding. "We are working hard and fast on this one and hope to have something as quickly Source: www.wvgazette.com Bush seeks $275 million more for the FDA - Baltimore Sun WASHINGTON - President Bush abruptly proposed yesterday a significant increase in government funding to ensure the safety of food and drug imports. The Bush administration requested giving the Food and Drug Administration an added $275million in Source: www.baltimoresun.com Grocers and Restaurants Toss Out Tomatoes - Wall Street Journal Restaurants and supermarkets across the country pulled certain fresh tomatoes from their menus and produce aisles in response to concerns about a recent spate of salmonella cases, delivering a serious blow to the nation's tomato growers. Fast-food Source: online.wsj.com Bush administration seeks more money to provide protection on food - International Herald Tribune WASHINGTON : The Food and Drug Administration on Monday night asked Congress for an additional $275 million for import protection, following a spate of criticism that the agency is trying to do too much with too few resources. The money would hire an Source: www.iht.com Frustration at FDA makes staff ripe for picking by drug firms - San Francisco Gate When pharmaceutical consulting firm Quintiles wants to hire an employee, the first place it looks is the Food and Drug Administration. These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Inc Source: www.sfgate.com FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Recalls and Safety Alerts: Neupro Patches Recalled Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th... FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. FDA orders boxed warning for Regranex - The Money Times FDA orders boxed warning for Regranex - The Money Times
Washington -- The U.S. Food and Drug Administration announced the addition of a boxed warning for Regranex (becaplermin) because of an increased risk of cancer mortality. The warning includes updated epidemiological data about the increased risk for Source: www.themoneytimes.com June 9, 2008Bush administration seeks more money so FDA can provide protection on - Minneapolis Star Tribune Bush administration seeks more money so FDA can provide protection on - Minneapolis Star Tribune
Montana cow tests positive for brucellosis Surrounded by sea, sailors kept afloat with hope Forecast: Dead zone off La., Texas coasts to grow 5 homes washed away in Wis. as Midwest rivers swell Obama ramps up search for a running mate WASHINGTON Source: www.startribune.com Metabolife co-founder gets 6 months for misleading FDA - San Francisco Gate A diet-pill company's co-founder and former chief executive has been sentenced to six months in prison for making false statements to federal regulators about the safety of a top-selling product. A federal judge in San Diego also fined Michael Ellis Source: www.sfgate.com Search for source of salmonella in tomatoes in high gear - Los Angeles Times Tomatoes disappeared from cheeseburgers. Fresh salsa was suddenly in short supply. Supermarket produce sections were in disarray. Homemakers checked the fridge, and waiters were pressed to explain why certain menu items were simply unavailable. Amid Source: www.latimes.com Tomatoes Pulled After Salmonella Warning Three Types Tied to Outbreak - Washington Post Tomatoes Pulled After Salmonella Warning Three Types Tied to Outbreak, FDA Says By Annys Shin Washington Post Staff Writer Tuesday, June 10, 2008; Source: www.washingtonpost.com McDonald's, others pull tomatoes over salmonella - Boston Globe Mark Roh, U.S. Food and Drug Administration's acting regional director holds a bag of tomatoes being tested for salmonella bacteria at FDA's southwest regional research lab, in Irvine, Calif., Monday June 9, 2008, where microbiologists are working Source: www.boston.com FDA Issues Warning After Outbreak Sickens 145 - Daily News-Record Harmony Heights Subway manager Jewel Ritchie calls the owner of the restaurant to find out what to do with last Friday's shipment of tomatoes, which have been sitting in the back since the U.S. Food and Drug Administration issued a warning that the Source: www.dnronline.com New FDA Rules Will Curb Drug Industry Profiteering - Scoop But Mark O. Thornton, MD, MPH, PhD, is not talking about the lobbyists and reps embedded in doctors' and lawmakers' offices even as patients and constituents wait for access. He's talking about Sen. Charles Grassley (R., Iowa), ranking member of the Source: www.scoop.co.nz FDA seeks increased funding for food safety - Reuters WASHINGTON (Reuters) - The Bush administration is asking Congress for an increase of $275 million above its current budget request to enhance federal food safety programs, U.S. Health Secretary Michael Leavitt said on Monday. The White House Source: www.reuters.com FDA Probing Tainted Tomatoes - TriCities.com As the U.S. Food and Drug Administration continues to investigate a surge of salmonella infections believed to come from certain tomatoes, local restaurants and retailers are taking precautions to keep customers safe. Since mid-April, 145 cases of Source: www.tricities.com Illegal Viagra Leads 24% Jump in Counterfeit Medicine Seizures - Bloomberg June 10 (Bloomberg) -- Counterfeit medicines are on the rise worldwide, as criminals capitalize on the growing use of the Internet by consumers searching for inexpensive drugs. Seizures of bogus prescription medicines jumped 24 percent to 1,513 Source: www.bloomberg.com Mommy's Bliss Nipple Cream Mommy's Bliss Nipple Cream
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30)
Fresca Italia of Brisbane, CA is recalling Burrata because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Administration seeks 275M to boost food import protection - Forbes Administration seeks 275M to boost food import protection - Forbes
The Food and Drug Administration on Monday night asked Congress for an additional $275 million for import protection, following a spate of criticism that the agency is trying to do too much with too few resources. The money would hire an additional Source: www.forbes.com Restaurants, stores withdraw tomatoes to avoid illness - Baltimore Sun Supermarkets and restaurants across Maryland are removing tomatoes from their shelves and menus after federal health officials warned of a widening outbreak of salmonella caused by some varieties of the fruit. Tomatoes have sickened more than 140 Source: www.baltimoresun.com Mylan gets FDA approval to market generic Sonata - MSN MoneyCentral PITTSBURGH (AP) - Mylan Inc. said Monday the Food and Drug Administration approved the company's application to sell generic capsules of Sonata, an insomnia treatment. The company will immediately begin shipping Zaleplon capsules in 5 and 10 mg doses Source: moneycentral.msn.com FDA: Heparin fraud suspected - Chicago Tribune U.S. regulators suspect that Baxter International Inc. 's blood-thinner heparin, linked to deaths and allergic reactions, was intentionally contaminated to increase profit. Andrew von Eschenbach, the commissioner of the Food and Drug Administration Source: www.chicagotribune.com McDonald’s pulls tomatoes over salmonella - MSNBC CHICAGO - McDonald's, Wal-Mart and other U.S. chains have halted sales of some raw tomatoes as federal health officials work to trace the source of a multistate salmonella food poisoning outbreak. Burger King, Outback Steakhouse and Taco Bell were Source: www.msnbc.msn.com McDonald's, Wal-Mart stop some tomato sales in wake of recall - Los Angeles Times McDonald's Corp, Wal-Mart Stores Inc and other restaurant and grocery chains have stopped selling certain tomatoes as U.S. health officials work to pinpoint the source of a salmonella outbreak. The Food and Drug Administration on Saturday warned U.S Source: www.latimes.com Mylan Announces Final FDA Approval for Zaleplon Capsules - Forbes PITTSBURGH, June 9 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Source: www.forbes.com Bush administration seeks more money so FDA can provide protection on - Minneapolis Star Tribune Montana cow tests positive for brucellosis Surrounded by sea, sailors kept afloat with hope Forecast: Dead zone off La., Texas coasts to grow 5 homes washed away in Wis. as Midwest rivers swell Obama ramps up search for a running mate WASHINGTON Source: www.startribune.com Three tomatoes varieties removed from shelves in S California - Xinhua News Agency LOS ANGELES, June 9 (Xinhua) -- Three tomato varieties have been removed from the shelves in Southern California as health officials warned of a widening Salmonella outbreak, authorities said on Monday. The removal came after the Food and Drug Source: news.xinhuanet.com Mylan gets FDA approval to market generic Sonata - CNN Money Mylan gets FDA approval to market generic Sonata - CNN Money
NEW YORK (Associated Press) - Mylan Inc. said Monday the Food and Drug Administration approved the company's application to sell generic capsules of Sonata, an insomnia treatment. The company will immediately begin shipping Zaleplon capsules in 5 and Source: money.cnn.com Tomato outbreak is reminder to follow food safety tips - FOX News A salmonella outbreak linked to raw tomatoes serves as a reminder to take extra care with summer fruits and vegetables. At least 23 people have been hospitalized as the government investigates the source of the tomatoes responsible for the illnesses Source: www.foxnews.com AMAG shares down, but analysts upbeat on lead drug - Forbes Most analysts who attended AMAG Pharmaceuticals Inc.'s investor meeting Friday came away upbeat about the biotechnology company's chances to win regulatory approval for anemia treatment and lead drug candidate, ferumoxytol. The Food and Drug Source: www.forbes.com Salmonella outbreak causes tomato recall - Los Angeles Times Restaurants, fast-food chains and supermarkets across Southern California removed fresh red Roma, plum and red round tomatoes from their shelves and took them off their menus this weekend as the U.S. government warned of a widening outbreak of Source: www.latimes.com Last Call: Vertex shares rise on hepatitis C drug data - CNN Money Last Call: Vertex shares rise on hepatitis C drug data - CNN Money
NEW YORK (Associated Press) - Shares of Vertex Pharmaceuticals rose Monday as the company released data showing the company's hepatitis C drug telaprevir worked on patients who had failed a common drug regimen. In the study, telaprevir was added to a Source: money.cnn.com Salmonella outbreak clears three tomato varieties from many markets - Los Angeles Times Salmonella outbreak clears three tomato varieties from many markets - Los Angeles Times
Restaurants, fast-food chains and supermarkets across Southern California removed fresh red Roma, plum and red round tomatoes from their shelves and took them off their menus this weekend as the U.S. government warned of a widening outbreak of Source: www.latimes.com FDA Issues Tomato Warning - KUTV The FDA is warning people nationwide to avoid eating Roma, plum and red round tomatoes due to a salmonella outbreak. Food poisoning linked to uncooked tomatoes has spread to at least 16 states, including Utah. The warning has prompted many Source: www.kutv.com Mylan Announces Final FDA Approval for Zaleplon Capsules - Forbes PITTSBURGH, June 9 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Source: www.forbes.com FDA criticizes Minnesota seafood company - Political Gateway WASHINGTON, June 9 (UPI) -- The U.S. Food and Drug Administration said it has asked for a permanent injunction against Captain's Select Seafood Inc. for violating federal law. The FDA said the Minneapolis company has an "extensive history of Source: www.politicalgateway.com FDA warns about eating Roma tomatoes - Public Opinion WASHINGTON, D.C., Monday, June 9 -- The Food and Drug Administration has expanded its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes and products Source: www.publicopiniononline.com FDA Adds Cancer Warning to Foot Cream - FOX News FDA Adds Cancer Warning to Foot Cream - FOX News
The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream medication Source: www.foxnews.com Frustration at FDA makes staff ripe for picking by drug firms - San Francisco Gate When pharmaceutical consulting firm Quintiles wants to hire an employee, the first place it looks is the Food and Drug Administration. These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Inc Source: www.sfgate.com Children's Medical Research Draws Scrutiny on Safety, Need - Bloomberg June 9 (Bloomberg) -- Medical research in children, an issue causing U.S. regulators to balance safety concerns against the need for more trials, is getting scrutiny that may lead to changes in federal guidelines. The U.S. Food and Drug Source: www.bloomberg.com Genta submits NDA amendment to FDA for leukemia drug - Pharmaceutical Business Review The submission is based on new information from the company's completed Phase III trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense Source: www.pharmaceutical-business-review.com Salmonella outbreak clears three tomato varieties from many markets - Los Angeles Times Restaurants, fast-food chains and supermarkets across Southern California removed fresh red Roma, plum and red round tomatoes from their shelves and took them off their menus this weekend as the U.S. government warned of a widening outbreak of Source: www.latimes.com FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. June 8, 2008FDA Announces Limited Return of Heartworm Drug to U.S. Market FDA Announces Limited Return of Heartworm Drug to U.S. Market
ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA issues nationwide Salmonella alert - KFSN FDA issues nationwide Salmonella alert - KFSN
The Food and Drug Administration on Wednesday issued an alert to consumers. 6/8/2008 ALBUQUERQUE, N.M. (KFSN) -- The FDA has issued a nationwide warning about certain raw tomoatoes. Salmonella food poisoning, linked to uncooked tomatoes, has now Source: abclocal.go.com UCLA Seeks Patients 8-to-17 with Friedreich’s Ataxia (FRDA) for New - Jewish Journal of Greater Los Angeles Programs UCLA Seeks Patients 8-to-17 with Friedreich’s Ataxia (FRDA) for New Drug Study FRDA is an inherited disease that causes progressive damage to the nervous system. Source: www.jewishjournal.com FDA adds most serious warning of cancer risks to Johnson & Johnson - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream Source: www.startribune.com FDA adds cancer warnings to J&J foot ulcer cream - Los Angeles Times WASHINGTON -- The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream Source: www.latimes.com FDA, Facing Criticism, Bars Doctors From Drug Trials (Update1) - Bloomberg FDA, Facing Criticism, Bars Doctors From Drug Trials (Update1) - Bloomberg
June 6 (Bloomberg) -- U.S. regulators have barred seven doctors from conducting clinical trials of drugs and medical devices so far this year, as many as in the three previous years combined, after lawmakers complained about delays in discipline. The Source: www.bloomberg.com FDA Takes Action against Cream Cheese Companies, Executives FDA Takes Action against Cream Cheese Companies, Executives
The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Drug to be Discontinued: Kemadrin (procyclidine hydrochloride)
Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Chantix (varenicline) Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. US FDA Grants Pediatric Exclusivity for UCB's Keppra(R) - Yahoo Finance US FDA Grants Pediatric Exclusivity for UCB's Keppra(R) - Yahoo Finance
SMYRNA, Ga., June 6 /PRNewswire/ -- UCB announced today that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra® (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written Source: biz.yahoo.com FDA adds cancer warnings to J&J foot ulcer cream - NWITimes.com WASHINGTON - The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream Source: nwitimes.com In shift, FDA says mercury fillings may harm some - Philadelphia Inquirer After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental amalgams contain Source: www.philly.com FDA Accepts Immucor's Response to Warning Letter - Forbes NORCROSS, Ga., June 6 /PRNewswire-FirstCall/ -- Immucor, Inc., (Nasdaq: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced that today the FDA notified the company that it has reviewed Source: www.forbes.com FDA eyes stricter rules for contact lens solutions - Los Angeles Times WASHINGTON -- Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the past two years. The Food and Drug Administration outlined several Source: www.latimes.com Prescription for disaster: drugs, lies, and greed - Boston Globe In mid-January, Merck and Schering-Plough announced that their cholesterol-lowering drugs Zetia and Vytorin, taken by 5 million people, may in fact increase the risk of heart attacks by encouraging the buildup of arterial plaque. Outraged critics Source: www.boston.com |
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