July 19, 2008Safety issues fail to halt drug imports - Newark Star-Ledger Safety issues fail to halt drug imports - Newark Star-Ledger
For 2 1/2 years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy plants in Source: www.nj.com HEALTH CARE: Rx push is on - Tonawanda News The county Legislature is being asked to give a renewed push to prescription drug discount cards that are available to every Niagara County resident. The Niagara Rx program has been in place for about four years, but it’s little used. According to Source: www.tonawanda-news.com China denies Olympic ban on drug sales - Reuters UK BEIJING (Reuters) - China denied on Friday that pharmacies had banned the sale of everyday products such as cold medication and rash cream to prevent accidental doping during the Olympics, and sought to assure that drugs would meet standards. Yan Source: uk.reuters.com Family Sues Company for Experimental Muscular Dystrophy Drug - FOX News A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress to Source: www.foxnews.com Tomato growers wonder if US crop can overcome bad rap from salmonella - Baltimore Sun RICHMOND, Va. (AP) _ The 6,000 acres of tomatoes grown on Virginia's sea-swept Eastern Shore were never implicated in the national salmonella outbreak — they were still on the vine weeks after people starting getting sick. Still, that hasn't made Source: www.baltimoresun.com Celera gets FDA approval for diagnostic software - CNBC ALAMEDA, Calif. - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is designed to Source: www.cnbc.com Should You Look Into Your Genes? - Washington Post Jeffrey Gulcher had no reason to think much about prostate cancer. He was just 48, and the disease typically strikes later in life. Even the most cautious medical groups agree that most men need not begin annual prostate screenings until age 50. But Source: www.washingtonpost.com Anti-smoking drug study investigated - The Washington Times Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and Source: washingtontimes.com Drug taken to stop smoking is linked to traffic mishaps - Fort Lauderdale Sun-Sentinel WASHINGTON - Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.sun-sentinel.com Family sues for trial muscular dystrophy drug - CNBC WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: www.cnbc.com May 2008 Monthly Safety Labeling May 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. FDA declares it's OK to eat tomatoes again - Seattle Post Intelligencer FDA declares it's OK to eat tomatoes again - Seattle Post Intelligencer
In this June 10, 2008 file photo, showing Canadian Hot House Tomatoes at a produce seller at the Reading Terminal Market in Philadelphia. The FDA declares it's OK to eat tomatoes again, Thursday, July 17, 2008, lifting its salmonella warning as Source: seattlepi.nwsource.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com Tomatoes OK to eat, FDA says, but avoid hot peppers - Houston Chronicle WASHINGTON — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing. Officials reiterated earlier warnings that the people most at Source: www.chron.com FDA Says It's Safe to Eat Tomatoes - Forbes THURSDAY, July 17 (HealthDay News) -- U.S. health officials on Thursday dropped their warning against eating fresh tomatoes, as the toll in the ongoing salmonella outbreak reached 1,220 confirmed cases, with at least 242 people hospitalized. "As of Source: www.forbes.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com FDA: OK to eat tomatoes again - USA Today Tomatoes are offered for sale at Eastern Market in Washington, D.C. WASHINGTON (AP) — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be Source: www.usatoday.com FDA declares it's OK to eat tomatoes again - Kansas City Star In this June 10, 2008 file photo, a plum tomato is displayed in Philadelphia. The U.S. government on Thursday, July 17, 2008 declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak _ while not over _ may Source: www.kansascity.com FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping System - PR Inside -- The addition in the resistance algorithm of two new drugs, INTELENCE(TM) (etravirine) and PREZISTA(TM) (darunavir) from Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.; -- An update of the resistance algorithm for all currently Source: www.pr-inside.com FDA: All Tomatoes Cleared of Salmonella Risk - Washington Post FDA: All Tomatoes Cleared of Salmonella Risk - Washington Post
All types of fresh tomatoes are safe to eat, federal health officials said yesterday, lifting a six-week-old warning that led restaurants to pull them and triggered tens of millions of dollars in losses for the tomato industry. Officials with the Source: www.washingtonpost.com Bush offers to talk on Iraq timetable - Detroit News WASHINGTON -- President Bush has agreed to set a "general time horizon" for deeper U.S. troop cuts in Iraq, the White House said Friday, a dramatic shift from his once-ironclad unwillingness to talk about any kind of deadlines or timetables. The Source: www.detnews.com FDA comes under Congress scanner over Ranbaxy issue - Times of India NEW YORK: The US drug regulator FDA, which has charged Ranbaxy of selling unsafe medicines in the country, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major's products and other potential Source: timesofindia.indiatimes.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA decides it's safe to eat tomatoes - Boston Globe WASHINGTON - It's OK to eat all kinds of tomatoes again, the US government declared yesterday - lifting its salmonella warning on the summer favorites amid signs the record outbreak, while not over, may finally be slowing. Hot peppers still get a Source: www.boston.com Stryker stock declines after warnings - Detroit Free Press Stryker stock declines after warnings - Detroit Free Press
Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com Family sues co. for muscular dystrophy drug - NWITimes.com WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: nwitimes.com Tomato scare squishes producers - United Press International SALINAS, Calif., July 19 (UPI) -- A recent salmonella outbreak has hit California tomato growers hard, with sales plummeting, experts say. Growers say by the time the U.S. Food and Drug Administration cleared tomatoes Thursday in its investigation of Source: www.upi.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com Medivation drug improves Alzheimer's symptoms - CNN Money NEW YORK (Associated Press) - Biotechnology company Medivation Inc. said Thursday that Alzheimer's disease patient's taking the experimental drug Dimebon showed a significant improvement after six months and continued to benefit from the drug up to a Source: money.cnn.com UPDATE 2-FDA approval for Labopharm's Tramadol seen by Jan - Reuters UPDATE 2-FDA approval for Labopharm's Tramadol seen by Jan - Reuters
TORONTO, July 17 (Reuters) - Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the Source: www.reuters.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger
For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters
TORONTO, July 17 (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) has provided on its once-daily version of the pain treatment Tramadol Source: www.reuters.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... 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. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 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 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. Myfortic (mycophenolate acid) Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA declares it's OK to eat tomatoes again - Boston Globe FDA declares it's OK to eat tomatoes again - Boston Globe
WASHINGTON— It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.boston.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters TORONTO, July 17 (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) has provided on its once-daily version of the pain treatment Tramadol Source: www.reuters.com BSD Medical Responds to FDA On Its BSD-2000 PMA Application - MSN MoneyCentral SALT LAKE CITY, July 17, 2008 (PRIME NEWSWIRE) -- BSD Medical Corporation (Nasdaq:BSDM) today announced that a formal response has been hand delivered to the Food and Drug Administration (FDA) pertaining to the BSD-2000 Hyperthermia System submission Source: news.moneycentral.msn.com Salmonella scare hit state growers hard - San Francisco Gate By the time the Food and Drug Administration cleared tomatoes Thursday in its investigation of a salmonella outbreak, California's tomato sales had plummeted more than 40 percent. "It's a government-made disaster," said Melanie Horwath, office Source: www.sfgate.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com FDA Revises Process for Responding to Drug Applications FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Stryker stock declines after warnings - Detroit Free Press Stryker stock declines after warnings - Detroit Free Press
Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com Family sues drug company to get access to muscular dystrophy drug - Newsday WASHINGTON (AP) _ A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: www.newsday.com OXiGENE Announces Clinical Trials Data to be Presented At the 7th - MSN MoneyCentral ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase Source: news.moneycentral.msn.com Traveler's diarrhea drug said to work - San Diego Union-Tribune A San Diego company developing an antibiotic for traveler's diarrhea said results from a late-stage clinical trial show that its product is faster and works on a broader range of gut-wrenching bacteria than those already on the market. The trial Source: www.signonsandiego.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com F.D.A. Lifts Tomato Warning - The Ledger The Food and Drug Administration revoked its warning against eating certain kinds of raw tomatoes Thursday, even though officials said they had yet to pinpoint the source of the nation’s largest foodborne outbreak in the last decade. Meanwhile, the Source: www.theledger.com Globalism and poison food - WorldNetDaily I mean, who would have imagined that opening up America's food sources to China and Mexico would mean consumers would be eating fish contaminated with human waste and tomatoes and avocadoes tainted with salmonella? Presumably our distinguished Source: www.worldnetdaily.com It’s Now Official: Tomatoes Are Salmonella-Free - Eflux Media On Thursday, federal health officials finally lifted the 40 day-old warning with regard to tomatoes, that has caused industry losses of about $250 million. Up to this point, investigators have analyzed more than 1,700 samples (soil, water and Source: www.efluxmedia.com Food bank, others aim to feed kids - Coloradoan With the number of children living in poverty on the rise in Larimer County, the Summer Food Service Program is feeding record numbers of children at the Fort Collins Boys & Girls Club. But the Food Bank for Larimer County and its partners want to Source: www.coloradoan.com Biocon to market new breast cancer drug in India - New Kerala Biocon to market new breast cancer drug in India - New Kerala
Bangalore, July 18: Biotechnology major Biocon Ltd will market Abraxane drug of the US-based Abraxis BioScience in India for treating breast cancer, a top company official said here Friday. To be priced at about $400 (Rs.17,200) per 100mg vial in Source: www.newkerala.com Stryker stock declines after warnings - Detroit Free Press Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com China drug regulator: Warning not a ban of drug sales - Xinhua News Agency BEIJING, July 17 (Xinhua) -- China's drug watchdog said Thursday it had not banned drug retailers from selling medicines containing stimulants during Olympics. A spokesman with the State Food and Drug Administration (SFDA) said drugstores should not Source: news.xinhuanet.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com A sour taste or sweet embrace? - Times Union Mike Ryan, vice president of W.F. Ryan Produce in Colonie, doesn't want to be one to say "I told you so" when it came to the tomato scare, but he did. When the Food and Drug Administration warned consumers on June 7 that certain tomato varieties may Source: timesunion.com Family Sues to Get Experimental Drug - AOL WASHINGTON (July 18) - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: news.aol.com Two US Congress members question Ranbaxy - MSN India New Delhi: Two United States (US) Congress members have expressed doubts over the quality of inspections that are conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities before giving them the nod to market Source: news.in.msn.com FDA: OK to eat tomatoes again - USA Today FDA: OK to eat tomatoes again - USA Today
Tomatoes are offered for sale at Eastern Market in Washington, D.C. WASHINGTON (AP) — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be Source: www.usatoday.com FDA declares it's OK to eat tomatoes again - NWITimes.com WASHINGTON - It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday _ lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get Source: nwitimes.com FDA: It’s OK to eat tomatoes again - MSNBC The U.S. government has declared it’s OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing. Officials reiterated earlier warnings that the people most at risk of Source: www.msnbc.msn.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com McCain gets uneasy over birth control - Miami Herald C onfronted with the question of whether insurance companies that cover Viagra should also pay for contraception, Republican John McCain channeled George Costanza . In a classic episode, the Seinfeld character balks when his fiancée says she's run Source: www.miamiherald.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com Florida tomato growers seek clear listing from FDA - Miami Herald State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com Growers want FDA to clear Fla.'s whole tomato crop - Boston Globe ORLANDO, Fla.— Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.boston.com China drug regulator: Warning not a ban of drug sales - Xinhua News Agency China drug regulator: Warning not a ban of drug sales - Xinhua News Agency
BEIJING, July 17 (Xinhua) -- China's drug watchdog said Thursday it had not banned drug retailers from selling medicines containing stimulants during Olympics. A spokesman with the State Food and Drug Administration (SFDA) said drugstores should not Source: news.xinhuanet.com Family Sues to Get Experimental Drug - AOL WASHINGTON (July 18) - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: news.aol.com Biocon to market new breast cancer drug in India - New Kerala Bangalore, July 18: Biotechnology major Biocon Ltd will market Abraxane drug of the US-based Abraxis BioScience in India for treating breast cancer, a top company official said here Friday. To be priced at about $400 (Rs.17,200) per 100mg vial in Source: www.newkerala.com A sour taste or sweet embrace? - Times Union Mike Ryan, vice president of W.F. Ryan Produce in Colonie, doesn't want to be one to say "I told you so" when it came to the tomato scare, but he did. When the Food and Drug Administration warned consumers on June 7 that certain tomato varieties may Source: timesunion.com Astellas wins Japan approval for new transplant drug - Reuters TOKYO, July 17 (Reuters) - Astellas Pharma Inc (4503.T: Quote , Profile , Research , Stock Buzz ) said on Thursday it had won approval to sell a new version of its key transplant drug in Japan, the second major region where it has gained approval Source: www.reuters.com OXiGENE Announces Clinical Trials Data to be Presented At the 7th - MSN MoneyCentral ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase Source: news.moneycentral.msn.com Food safety - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com Two US Congress members question Ranbaxy - MSN India New Delhi: Two United States (US) Congress members have expressed doubts over the quality of inspections that are conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities before giving them the nod to market Source: news.in.msn.com Celera gets FDA approval for diagnostic software - CNN Money NEW YORK (Associated Press) - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is Source: money.cnn.com July 18, 2008Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... 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. 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. 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. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. 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 FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Drug Shortage: Fentanyl transdermal patch Availability information updated. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald
ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com April 2008 Monthly Safety Labeling April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Red Tomato Warning Expanded Nationwide 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. Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. 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 declares it's OK to eat tomatoes again - Forbes FDA declares it's OK to eat tomatoes again - Forbes
It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get a caution Source: www.forbes.com FDA Panel: J&J's Doribax Effective For Nosocomial Pneumonia - CNN Money Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat pneumonia for patients on mechanical ventilation units, a panel of medical experts told federal regulators Wednesday. Panel members, however Source: money.cnn.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA unveils plan to recruit young science staffers - CNN Money NEW YORK (Associated Press) - The Food and Drug Administration has unveiled a plan for recruiting young staffers to replace the hundreds of scientists retiring from the agency. The FDA said Thursday it will launch a two-year fellowship program for Source: money.cnn.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com Florida tomato growers seek clear listing from FDA - Miami Herald State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com FDA declares it's OK to eat tomatoes again - Miami Herald WASHINGTON -- The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak - while not over - may finally be slowing. Officials reiterated earlier warnings that the people most at risk of Source: www.miamiherald.com Celera gets FDA approval for diagnostic software - CNN Money NEW YORK (Associated Press) - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is Source: money.cnn.com Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, 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. FDA declares it's OK to eat tomatoes again - Forbes FDA declares it's OK to eat tomatoes again - Forbes
It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get a caution Source: www.forbes.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com FDA declares tomatoes safe, but peppers not off the hook - Philadelphia Inquirer WASHINGTON - It's OK to eat all kinds of tomatoes again, the U.S. government declared yesterday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.philly.com FDA: Salmonella cases not linked to tomatoes - AZCentral.com Federal officials said Thursday that all tomatoes on the U.S. market are safe to eat but they still don't know what's causing a salmonella outbreak that's sickened thousands over the past three months. Jalapeno and serrano peppers remain the focus of Source: www.azcentral.com FDA protecting wrong party - Philadelphia Inquirer Richard Golomb is a past president of the Philadelphia Trial Lawyers Association More than 200 years ago, America's greatest patriots convened to write a document that would empower us all with inalienable rights, liberties and freedoms. But on this Source: www.philly.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping System - MSN MoneyCentral Celera CRA today announced that it has received marketing clearance from the U.S. Food and Drug Administration for its 510(k) submission of the ViroSeq HIV-1 Genotyping System Software v2.8. The ViroSeq HIV-1 Genotyping ™ System is designed to Source: news.moneycentral.msn.com FDA Panel: J&J's Doribax Effective For Nosocomial Pneumonia - CNN Money Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat pneumonia for patients on mechanical ventilation units, a panel of medical experts told federal regulators Wednesday. Panel members, however Source: money.cnn.com Salmonella warnings lifted on tomatoes - Miami Herald Salmonella warnings lifted on tomatoes - Miami Herald
Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA: Salmonella cases not linked to tomatoes - AZCentral.com Federal officials said Thursday that all tomatoes on the U.S. market are safe to eat but they still don't know what's causing a salmonella outbreak that's sickened thousands over the past three months. Jalapeno and serrano peppers remain the focus of Source: www.azcentral.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com FDA says tomatoes are safe; peppers suspect - Seattle Times WASHINGTON — It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday — lifting its salmonella warning amid signs the record outbreak, while not over, finally may be slowing. Hot peppers still get a caution: The people Source: seattletimes.nwsource.com FDA declares it's OK to eat tomatoes again - Boston Globe WASHINGTON— It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.boston.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald
ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com Allergy Drug Turned Alzheimer's Therapy Shows Promise - ABC News A pill once used as an antihistamine in Russia has shown a slight but unique promise for treating Alzheimer's disease and is now on a fast track to drug studies in the United States. A Russian drug called Dimebon is showing promise in early clinical Source: www.abcnews.go.com Across the nation - Detroit Free Press Tomatoes sold in the United States are safe to eat now, the Food and Drug Administration said Thursday, lifting its warning about the risk of salmonella contamination. But the FDA reiterated warnings that people most at risk should avoid jalapeno and Source: www.freep.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com AGI Therapeutics says on track for data on 'Rezular' from Phase III in - CNBC LONDON (Thomson Financial) - AGI Therapeutics Plc. said it believes it is on track to report preliminary data from its ongoing Phase III efficacy study for its 'Rezular' drug, in the first half of 2009. The company said it met with the U.S. Food and Source: www.cnbc.com China's drug supervision is ready for the Olympics - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China's drug supervision system is ready for the Olympics, a drug watchdog spokeswoman said on Friday. China has intensified inspection and testing measures for drugs to safeguard drug safety for Olympic athletes, the Source: news.xinhuanet.com Salmonella warnings lifted on tomatoes - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com New Medical Products: New Non-Refrigerated Coagulation Product New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... July 17, 2008Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. 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. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 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: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Family sues for trial muscular dystrophy drug - CNBC Family sues for trial muscular dystrophy drug - CNBC
WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: www.cnbc.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com Connecticut receiving $2 million drug maker case - Boston Globe HARTFORD, Conn.— Attorney General Richard Blumenthal says Connecticut will be receiving almost $2 million as part of a national settlement with drug maker Bristol-Myers Squibb . The agreement settles allegations that the company and a former Source: www.boston.com Family sues co. for muscular dystrophy drug - San Francisco Gate A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress to Source: www.sfgate.com Eating tomatoes is safe again despite salmonella outbreak - Los Angeles Times WASHINGTON -- It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its warning on the summer favorite amid signs that the Salmonella Saintpaul outbreak, while not over, may finally be slowing. Hot peppers still Source: www.latimes.com FDA Clears Suspect Tomatoes - ABC News The Food and Drug Administration lifted its tomato alert today despite uncertainty about what caused so many illnesses in recent months. Officials cleared tomatoes because the farms that may have shipped them at the beginning of the outbreak in May Source: abcnews.go.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Radiology and Children: Extra Care Required Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Florida tomato growers seek clear listing from FDA - Miami Herald Florida tomato growers seek clear listing from FDA - Miami Herald
State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com Misonix (MSON) Receives FDA Marketing Clearance for its Sonatherm 600i - StreetInsider.com Misonix, Inc. (NASDAQ: MSON ) has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its Sonatherm 600i High Intensity Focused Ultrasound ("HIFU") Soft Tissue Ablation System in the United States, which will be Source: www.streetinsider.com FDA comes under Congress scanner over Ranbaxy - Livemint.com New York: The US drug regulator FDA, which has charged Ranbaxy of selling unsafe medicines in the country, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major’s products and other Source: www.livemint.com Approval for Labopharm's Tramadol seen by January - Reuters Canada TORONTO (Reuters) - Labopharm Inc (DDS.TO: Quote ) inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the analysis provided by the Canadian drug company Source: ca.reuters.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com Tomatoes are fine, but FDA links jalepeno and seranno peppers to - Atlanta Journal Constitution The U.S. Food and Drug Administration is no longer warning consumers to avoid tomatoes, officials said this afternoon. But they said elderly people, young children and people with compromised immune systems should continue to avoid raw jalepeno and Source: www.ajc.com US Cong Committee to probe into FDA’s findings on Ranbaxy - Economic Times US Cong Committee to probe into FDA’s findings on Ranbaxy - Economic Times
NEW DELHI: A US Congressional Committee is launching an investigation into whether US Food and Drug Administration (FDA) was lenient in allowing Ranbaxy to sell new drugs in the US market, when it was still investigating discrepancies at the Indian Source: economictimes.indiatimes.com Misonix (MSON) Receives FDA Marketing Clearance for its Sonatherm 600i - StreetInsider.com Misonix, Inc. (NASDAQ: MSON ) has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its Sonatherm 600i High Intensity Focused Ultrasound ("HIFU") Soft Tissue Ablation System in the United States, which will be Source: www.streetinsider.com FDA: It’s OK to eat tomatoes again - MSNBC The U.S. government has declared it’s OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing. Officials reiterated earlier warnings that the people most at risk of Source: www.msnbc.msn.com FDA Panel: J&J's Doribax Effective For Nosocomial Pneumonia - CNN Money Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat pneumonia for patients on mechanical ventilation units, a panel of medical experts told federal regulators Wednesday. Panel members, however Source: money.cnn.com Growers Ask FDA To Clear Tomatoes - The Ledger State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.theledger.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com State Police and FDA Agents Swarm West Monroe Office Building with - KNOE TV8 State Police and FDA Agents Swarm West Monroe Office Building with - KNOE TV8
WEST MONROE (KNOE 8 News) - State police and agents with the Food and Drug Administration (FDA) are executing a search warrant at 3602 Cypress Street in West Monroe . Several doctors and other professional offices are located inside the building at Source: www.knoe.com Menthol used to hook young smokers - Hindustan Times Tobacco companies manipulate the amount of menthol in cigarettes to make those first few puffs more palatable to young smokers, US researchers said on Wednesday in a finding that could fuel support for more tobacco regulation. “Menthol stimulates Source: www.hindustantimes.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com Misonix (MSON) Receives FDA Marketing Clearance for its Sonatherm 600i - StreetInsider.com Misonix, Inc. (NASDAQ: MSON ) has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its Sonatherm 600i High Intensity Focused Ultrasound ("HIFU") Soft Tissue Ablation System in the United States, which will be Source: www.streetinsider.com BSD Medical Responds to FDA On Its BSD-2000 PMA Application - MSN MoneyCentral SALT LAKE CITY, July 17, 2008 (PRIME NEWSWIRE) -- BSD Medical Corporation (Nasdaq:BSDM) today announced that a formal response has been hand delivered to the Food and Drug Administration (FDA) pertaining to the BSD-2000 Hyperthermia System submission Source: news.moneycentral.msn.com Tracking Produce Proves Complex - Los Angeles Times The salmonella outbreak of 2008 may go down in history as the case of the missing tomatoes. More than six weeks ago, the Food and Drug Administration issued a warning about a salmonella outbreak in New Mexico and Texas connected to raw tomatoes Source: www.latimes.com Marijuana Mouth Spray: The New Pain Reliever? - FOX News A new marijuana mouth spray aimed at relieving pain is being reviewed by the U.S. Food and Drug Administration in clinical trials, USA Today reported. Source: www.foxnews.com Nymox's NicAlert(TM) Gains Acceptance in Clinical Trials and Research - MSN MoneyCentral Nymox Pharmaceutical Corporation ’ s NYMX NicAlert ™ product has gained acceptance as an important tool in research studies and clinical trials where it is important to know the level of tobacco use or exposure among participants. Recent peer Source: news.moneycentral.msn.com HAE: Biotech's Latest Orphan-Drug Race - Street.Com A rare genetic disorder known as hereditary angiodema (HAE) is attracting a great deal of attention from drugmakers these days. On Tuesday, ViroPharma VPHM said it will spend a minimum of $443 million to buy Lev Pharmaceuticals LEVP , which is Source: www.thestreet.com HAE: Biotech's Latest Orphan-Drug Race - Street.Com HAE: Biotech's Latest Orphan-Drug Race - Street.Com
A rare genetic disorder known as hereditary angiodema (HAE) is attracting a great deal of attention from drugmakers these days. On Tuesday, ViroPharma VPHM said it will spend a minimum of $443 million to buy Lev Pharmaceuticals LEVP , which is Source: www.thestreet.com UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters TORONTO, July 17 (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) has provided on its once-daily version of the pain treatment Tramadol Source: www.reuters.com Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald
ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com Color Me Concerned - Baltimore Sun A lmost 40 years ago, artificial food dyes had their moment in the sun. In 1969, Soviet scientists announced that Red Dye #2 caused cancer in rats. Seven years later, the Food and Drug Administration agreed, and banned the ubiquitous coloring from U Source: www.baltimoresun.com Traveler's diarrhea drug said to work - San Diego Union-Tribune A San Diego company developing an antibiotic for traveler's diarrhea said results from a late-stage clinical trial show that its product is faster and works on a broader range of gut-wrenching bacteria than those already on the market. The trial Source: www.signonsandiego.com Recalled food products found in Twin Lakes Area - Baxter Bulletin WASHINGTON — Nestlé Prepared Foods Co., a Mt. Sterling, Ky., establishment, has recalled approximately 199,417 pounds of frozen stuffed-chicken sandwich products that may contain pieces of plastic, the U.S. Department of Agriculture's Food Safety Source: www.baxterbulletin.com Florida tomato growers seek clear listing from FDA - Miami Herald State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com Western Tomato Growers Asks FDA to Lift Consumption Advisory - Wisconsin Ag Connection Western Growers' President and CEO Tom Nassif sent a letter yesterday to Food and Drug Administration Commissioner Andrew von Eschenbach urging him to make a strong public announcement that all tomatoes grown in the United States, regardless of Source: www.wisconsinagconnection.com Red Cross falls short on blood services - Seattle Times Red Cross falls short on blood services - Seattle Times
For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow safety procedures, it continues to fall short Source: seattletimes.nwsource.com Menthol the bait to trap smokers, researchers say - Boston Globe Hoping to lure a new generation of smokers, tobacco companies routinely manipulate levels of menthol so that their cigarettes prove more appealing and less harsh to novice users, Boston researchers reported yesterday. Scientists from the Harvard Source: www.boston.com US Cong to probe FDA's Ranbaxy 'fraud' case - IBN LIve DRUG SCANDAL: The FDA has declined to comment, saying the case is under investigation. New Delhi: The US Congress is planning to probe the US FDA 's handling of the Ranabaxy case and whether it consistently overlooked signs that the drugmaker was Source: www.ibnlive.com FDA comes under US Congress scanner over Ranbaxy issue - Zee News New York, July 17: The US drug regulator FDA, which has charged Ranbaxy of selling unsafe medicines in the country, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major's products and other Source: www.zeenews.com FDA Advisory Committee Provides Opinion of DORIBAX(TM) for the - PR Newswire RARITAN, N.J., July 16 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in favor of the efficacy and Source: sev.prnewswire.com Color Me Concerned - Baltimore Sun A lmost 40 years ago, artificial food dyes had their moment in the sun. In 1969, Soviet scientists announced that Red Dye #2 caused cancer in rats. Seven years later, the Food and Drug Administration agreed, and banned the ubiquitous coloring from U Source: www.baltimoresun.com FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. 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. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. New Medical Products: New Skin Graft Adhesive Approved New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. July 16, 2008Convention centers' food vendor may be fired - Boston Globe Convention centers' food vendor may be fired - Boston Globe
The Massachusetts Convention Center Authority has notified Aramark Corp. that it is looking for someone else to provide food and beverage services at the Boston Convention & Exhibition Center and the John B. Hynes Veterans Memorial Convention Center Source: www.boston.com July 2008 Patient Safety News July 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. 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. Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. 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. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Western Growers Asks FDA Commissioner to Lift Tomato Consumption - Forbes Western Growers Asks FDA Commissioner to Lift Tomato Consumption - Forbes
IRVINE, C alif. , July 16 /PRNewswire-USNewswire/ -- Western Growers' President and CEO Tom Nassif sent a letter yesterday to Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach urging him to make a strong public announcement that Source: www.forbes.com Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Stronger Warnings Requested for Fluoroquinolones Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. 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. 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. Natalie Cole says she has hepatitis C - USA Today Natalie Cole says she has hepatitis C - USA Today
Natalie Cole has been diagnosed with hepatitis C, according to a statement released by her publicist on Wednesday. NEW YORK (AP) — Grammy-winning singer Natalie Cole has been diagnosed with hepatitis C, her publicist said in a statement Wednesday Source: www.usatoday.com Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With - MSN MoneyCentral SEATTLE , July 16 /PRNewswire-FirstCall/ -- Dendreon Corporation DNDN today announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate Source: news.moneycentral.msn.com BioSante Pharmaceuticals Announces FDA Special Protocol Assessment - PR Inside - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached an additional agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its Source: www.pr-inside.com Wal-Mart: the new FDA - CNN Money The giant retailer, along with CVS ( CVS , Fortune 500 ) and Toys 'R Us, announced recently that it plans to stop selling baby bottles containing the chemical bisphenol-A. The question is, why? Bisphenol-A has been widely used since the 1950s. The Source: money.cnn.com Mexican officials in US to demand Mexican tomatoes be cleared of - Chicago Tribune MEXICO CITY (AP) _ Mexico's health secretary says a team of health and agriculture officials has traveled to the United States to demand that Mexican tomatoes be cleared of any suspicion in a recent salmonella outbreak.Jose Angel Cordova says the Source: www.chicagotribune.com Selexis Now Offering Rapid-Development of Human Cell Line With FDA - Phramalive.com New contract service offering rapid development of high performance HEK293 (human) production cell lines enabled by Selexis Genetic Elements(TM) and Selexis SURE(TM) Cell Line Development program GENEVA, July 16, 2008 /PRNewswire/ -- Selexis SA, a Source: www.pharmalive.com U.S. FDA staff questions J&J antibiotic studies - Forbes WASHINGTON, (Reuters) - U.S. drug reviewers have major concerns about effectiveness data supplied by Johnson & Johnson in a bid to win approval for wider use of its Doribax antibiotic, documents released Monday said. The Food and Drug Administration Source: www.forbes.com Jazz Pharmaceuticals plans $26M stock sale - MSN MoneyCentral Jazz Pharmaceuticals Inc. said Wednesday it entered agreements with selected investors to raise about $26 million in a sale of stock and warrants. Palo Alto-based Jazz (NASDAQ:JAZZ) said its costs in connection with the offering are expected to be Source: news.moneycentral.msn.com Success, concerns at family tobacco firm - Boston Globe Success, concerns at family tobacco firm - Boston Globe
KEYSVILLE, Va. - Like generations of family before him, Steven Bailey grew up with tobacco. The leafy plants thrive in Virginia's rich clay soil, and one of his earliest memories is of watching his mother work the fields, surrounded by plants as high Source: www.boston.com Ranbaxy denies USFDA allegations - Zee News New Delhi, July 16: Pharma major Ranbaxy Wednesday denied allegations by the US Food and Drug Administration regarding submission of false and fabricated information, on the back of which the company's shares opened five percent up on the Bombay Source: www.zeenews.com Reactions mixed on pepper link to salmonella - San Diego Union-Tribune The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are cautioning people at high risk for contracting salmonella to avoid eating raw jalapenos, serrano peppers and fresh cilantro, in addition to certain raw Source: www.signonsandiego.com Beware of Online Cancer Fraud Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Raptor Pharmaceuticals Enters Collaboration Agreement with UC San - MSN MoneyCentral Raptor Pharmaceuticals Enters Collaboration Agreement with UC San - MSN MoneyCentral
- Raptor to Support Phase 2a Clinical Trial at UCSD NOVATO, California , July 16 /PRNewswire/ -- Raptor Pharmaceuticals Corp. ("Raptor" or the "Company") (OTC Bulletin Board: RPTP), today announced the execution of a collaboration agreement (the Source: news.moneycentral.msn.com Dendreon Initiates Phase 2 Trial of PROVENGE in Patients With - MSN MoneyCentral SEATTLE , July 16 /PRNewswire-FirstCall/ -- Dendreon Corporation DNDN today announced that the Company has initiated a Phase 2 trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active cellular immunotherapy for the treatment of prostate Source: news.moneycentral.msn.com Ranbaxy denies US FDA allegations; shares up 9% - Business Standard Pharma major Ranbaxy today denied allegations by the US Food and Drug Administration regarding submission of false and fabricated informations, on the back of which the company's shares opened five per cent up on the Bombay Stock Exchange. "Ranbaxy Source: www.business-standard.com FDA staff questions J&J antibiotic studies - Reuters WASHINGTON (Reuters) - U.S. drug reviewers have "several major concerns" about effectiveness data supplied by Johnson & Johnson in a bid to expand use of its antibiotic Doribax, according to documents released on Monday. The Food and Drug Source: www.reuters.com Natalie Cole says she has hepatitis C - Newsday Grammy-winning singer Natalie Cole has been diagnosed with hepatitis C, her publicist said in a statement Wednesday. Hepatitis C is a liver disease spread through contact with infected blood. The statement said the disease was revealed during a Source: www.newsday.com US prosecutors allege Indian drug maker Ranbaxy forged documents - International Herald Tribune WASHINGTON : Federal prosecutors allege that Indian generic drugmaker Ranbaxy Laboratories deliberately misled the U.S. government about the quality of its low-cost medicines. The Justice Department is demanding Ranbaxy turn over documents which it Source: www.iht.com FDA: Genentech's Avastin Tied To Several Cases Of Anemia - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Monday issued an alert about Genentech Inc.'s (DNA) blockbuster cancer drug Avastin, saying the drug has been tied to the development of anemia in several patients. Several patients Source: money.cnn.com Mexican officials in US to demand Mexican tomatoes be cleared of - Los Angeles Times MEXICO CITY (AP) _ Mexico's health secretary says a team of health and agriculture officials has traveled to the United States to demand that Mexican tomatoes be cleared of any suspicion in a recent salmonella outbreak.Jose Angel Cordova says the Source: www.latimes.com FDA issues warning on CT scans for patients with pacemakers - Chicago Tribune FDA issues warning on CT scans for patients with pacemakers - Chicago Tribune
The Food and Drug Administration is warning doctors and patients that electronic devices such as pacemakers, cardiac defibrillators and insulin pumps can malfunction when people get computerized tomography (CT) scans. The popular scans can cause Source: www.chicagotribune.com Natalie Cole says she has hepatitis C - International Herald Tribune NEW YORK : Grammy-winning singer Natalie Cole has been diagnosed with hepatitis C, her publicist said in a statement Wednesday. Hepatitis C is a liver disease spread through contact with infected blood. The statement said the disease was revealed Source: www.iht.com Ranbaxy Rebounds After Saying Sale to Daiichi Sankyo Is Binding - Bloomberg July 16 (Bloomberg) -- Ranbaxy Laboratories Ltd. , India's largest drugmaker, rose as much as 10 percent, rebounding from the biggest two-day slide in at least 17 years, after saying a U.S. legal probe won't derail its sale to Daiichi Sankyo Co. The Source: www.bloomberg.com Ranbaxy denies FDA allegations; shares up 9% - Express India New Delhi, July 16: Pharma major Ranbaxy on Wednesday denied allegations by the US Food and Drug Administration regarding submission of false and fabricated informations, on the back of which the company's shares opened five per cent up on the Bombay Source: www.expressindia.com FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP - MSN MoneyCentral Amgen Inc. AMGN today announced that the U.S. Food and Drug Administration (FDA) has approved Nplate ™ (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non Source: news.moneycentral.msn.com Drugs and Treatments - Humira SubQ - WebMD Drugs and Treatments - Humira SubQ - WebMD
This medication can decrease your immune system's ability to fight infections. Though unlikely, this drug may slightly increase your risk of developing serious, possibly fatal, infections. This risk is higher if you are also taking other drugs to Source: www.webmd.com Drug prevents bone loss in prostate cancer: Amgen - Reuters CHICAGO (Reuters) - Amgen Inc on Monday said that a trial of its experimental drug denosumab showed that it can prevent osteoporosis in men being treated with prostate cancer drugs that can cause bone loss. The three-year study of more than 1,400 men Source: www.reuters.com July 15, 2008Micrus Endovascular Receives FDA Approval for Intracranial Stent - MSN MoneyCentral Micrus Endovascular Receives FDA Approval for Intracranial Stent - MSN MoneyCentral
Micrus Endovascular Corporation MEND today announced that the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally approved by the U.S. Food and Drug Administration (FDA). The Pharos Source: news.moneycentral.msn.com Reactions mixed on pepper link to salmonella - San Diego Union-Tribune The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are cautioning people at high risk for contracting salmonella to avoid eating raw jalapenos, serrano peppers and fresh cilantro, in addition to certain raw Source: www.signonsandiego.com Genentech ends studies on drug combo safety issue - CNN Money NEW YORK (Associated Press) - Biotechnology company Genentech Inc. ended several studies combining its cancer drug Avastin and Pfizer Inc.'s Sutent because several patients developed a type of anemia. On Monday, the Food and Drug Administration Source: money.cnn.com Drug prevents bone loss in prostate cancer: Amgen - Reuters CHICAGO (Reuters) - Amgen Inc on Monday said that a trial of its experimental drug denosumab showed that it can prevent osteoporosis in men being treated with prostate cancer drugs that can cause bone loss. The three-year study of more than 1,400 men Source: www.reuters.com State gets $12M in drug company settlement - Atlanta Journal Constitution Georgia has received almost $12.1 million for its Medicaid program — its share of a settlement Bristol-Myers Squibb reached with the federal government and 43 states for the questionable marketing and pricing of certain prescription drugs for the Source: www.ajc.com Ranbaxy faces fraud probe by US Food and Drug Administration - Times Online Ranbaxy, India's largest producer of generic drugs, is being investigated by United States officials for alleged fraud that may have led to substandard medicines being sold in the US. The Indian company confirmed that it has been approached by Source: business.timesonline.co.uk FDA Spends Too Much on Employee Parties, Not Enough on Food Safety - Common Dreams WASHINGTON - July 15 - “In a time of increasing concern over the safety of our food supply, it is disconcerting to hear of frivolous spending from a federal agency that is charged with protecting consumers’ safety. Yet unfortunately this is the Source: www.commondreams.org Amgen gets FDA approval for platelet disorder drug - MSN MoneyCentral THOUSAND OAKS, Calif. (AP) - Biotechnology company Amgen Inc. said Monday the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. The drug treats the autoimmune disorder chronic immune Source: moneycentral.msn.com Drug prevents bone loss in prostate cancer: Amgen - Reuters Drug prevents bone loss in prostate cancer: Amgen - Reuters
CHICAGO (Reuters) - Amgen Inc on Monday said that a trial of its experimental drug denosumab showed that it can prevent osteoporosis in men being treated with prostate cancer drugs that can cause bone loss. The three-year study of more than 1,400 men Source: www.reuters.com Amgen gets FDA approval for platelet disorder drug - MSN MoneyCentral THOUSAND OAKS, Calif. (AP) - Biotechnology company Amgen Inc. said Monday the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. The drug treats the autoimmune disorder chronic immune Source: moneycentral.msn.com Ranbaxy faces fraud probe by US Food and Drug Administration - Times Online Ranbaxy, India's largest producer of generic drugs, is being investigated by United States officials for alleged fraud that may have led to substandard medicines being sold in the US. The Indian company confirmed that it has been approached by Source: business.timesonline.co.uk Amgen retracts FDA Nplate approval statement - CNN Money NEW YORK (Associated Press) - Biotechnology company Amgen Inc. erroneously announced Monday that the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. The drug is in fact still under Source: money.cnn.com Ranbaxy in hot water with US FDA - BusinessWeek Talk about unfortunate timing. Barely a month after Ranbaxy Laboratories, India’s largest drug maker, entered into a landmark deal to sell out to Japan’s pharmaceutical major Daiichi Sankyo, it now has the U.S. Food and Drug Administration out Source: www.businessweek.com Entries for July 2008 - US News and World Report Entries for July 2008 - US News and World Report
When I recently heard about the website Women on Web , which allows women in countries like Ireland, Argentina, and Afghanistan that outlaw abortions to purchase abortion pills over the Internet, I had mixed feelings. On the one hand, mifepristone Source: www.usnews.com Drug prevents bone loss in prostate cancer: Amgen - Reuters CHICAGO (Reuters) - Amgen Inc on Monday said that a trial of its experimental drug denosumab showed that it can prevent osteoporosis in men being treated with prostate cancer drugs that can cause bone loss. The three-year study of more than 1,400 men Source: www.reuters.com Reactions mixed on pepper link to salmonella - San Diego Union-Tribune The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are cautioning people at high risk for contracting salmonella to avoid eating raw jalapenos, serrano peppers and fresh cilantro, in addition to certain raw Source: www.signonsandiego.com FDA OKs ThermoGenesis' MarrowXpress device - MSN MoneyCentral ThermoGenesis Corp. got the OK from the Food and Drug Administration to begin selling a device for separating and storing adult stem cells from bone marrow. The FDA approved the use of the MarrowXpress device in clinical laboratories or for use Source: news.moneycentral.msn.com Mexico demands US clear its tomatoes - Forbes Mexico demands US clear its tomatoes - Forbes
Mexico's health secretary says a team of health and agriculture officials has traveled to the United States to demand that Mexican tomatoes be cleared of any suspicion in a recent salmonella outbreak. Jose Angel Cordova says the group will meet with Source: www.forbes.com Ranbaxy in hot water with US FDA - BusinessWeek Talk about unfortunate timing. Barely a month after Ranbaxy Laboratories, India’s largest drug maker, entered into a landmark deal to sell out to Japan’s pharmaceutical major Daiichi Sankyo, it now has the U.S. Food and Drug Administration out Source: www.businessweek.com Earnings Preview: Abbott expected to post solid 2Q - Boston Globe WASHINGTON— Drug and medical device company Abbott Laboratories reports earnings for the second quarter on Wednesday. The following is a summary of key developments and analyst opinion related to the period. OVERVIEW: Earlier this month, Abbott won Source: www.boston.com Micrus Endovascular Receives FDA Approval for Intracranial Stent - MSN MoneyCentral Micrus Endovascular Corporation MEND today announced that the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally approved by the U.S. Food and Drug Administration (FDA). The Pharos Source: news.moneycentral.msn.com Mexico demands US clear its tomatoes - Forbes Mexico demands US clear its tomatoes - Forbes
Mexico's health secretary says a team of health and agriculture officials has traveled to the United States to demand that Mexican tomatoes be cleared of any suspicion in a recent salmonella outbreak. Jose Angel Cordova says the group will meet with Source: www.forbes.com Cephalon drug prompts response in cancer study - Boston Globe FRAZER, Pa.— Biotechnology company Cephalon Inc. said Tuesday its leukemia drug Treanda, in combination with Genentech Inc.'s Rituxan, prompted a response in non-Hodgkin's lymphoma patients during a midstage study. The study results were published Source: www.boston.com Ranbaxy in hot water with US FDA - BusinessWeek Talk about unfortunate timing. Barely a month after Ranbaxy Laboratories, India’s largest drug maker, entered into a landmark deal to sell out to Japan’s pharmaceutical major Daiichi Sankyo, it now has the U.S. Food and Drug Administration out Source: www.businessweek.com Micrus Endovascular Receives FDA Approval for Intracranial Stent - MSN MoneyCentral Micrus Endovascular Corporation MEND today announced that the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally approved by the U.S. Food and Drug Administration (FDA). The Pharos Source: news.moneycentral.msn.com Earnings Preview: Abbott expected to post solid 2Q - Boston Globe WASHINGTON— Drug and medical device company Abbott Laboratories reports earnings for the second quarter on Wednesday. The following is a summary of key developments and analyst opinion related to the period. OVERVIEW: Earlier this month, Abbott won Source: www.boston.com ViroPharma to Buy Lev Pharma - Street.Com ViroPharma VPHM is buying Lev Pharmaceuticals LEVP , a deal that will add a late-stage drug targeting a rare genetic inflammatory disease to its pipeline, the companies announced Tuesday. The purchase price is $442.9 million, or $2.75 a share, a 49 Source: www.thestreet.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. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. 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. Drug Shortage: MVI Adult Injectable Hospira information updated. Pro-Pharmaceuticals Has Requested a Pre-IND Meeting with the U.S. Food - MSN MoneyCentral Pro-Pharmaceuticals Has Requested a Pre-IND Meeting with the U.S. Food - MSN MoneyCentral
Pro-Pharmaceuticals, Inc. PRW , a biopharmaceutical company developing proprietary polysaccharide-based therapeutic compounds in the treatment of cancer and fibrosis, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Source: news.moneycentral.msn.com Ranbaxy shares tumble 2nd day on U.S. probe - Reuters India NEW DELHI (Reuters) - Shares in India's Ranbaxy Laboratories tumbled 15 percent on Tuesday, sliding for a second day on concerns a U.S. probe could hit the drug maker's sales in one of its main markets. The U.S. authorities have alleged that Ranbaxy Source: in.reuters.com FDA Questions J&J Studies To Expand Antibiotic Doribax - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Monday said it has major concerns about Johnson & Johnson (JNJ) studies submitted to make the company's case to expand the use of the antibiotic Doribax. Raritan, N.J.-based Johnson Source: money.cnn.com Amgen retracts FDA Nplate approval statement - CNN Money NEW YORK (Associated Press) - Biotechnology company Amgen Inc. erroneously announced Monday that the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. The drug is in fact still under Source: money.cnn.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. July 14, 2008FDA 101: How to Use the Consumer Complaint System and MedWatch FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. 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) Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. Myfortic (mycophenolate acid) Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... March 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. UPDATE 2-Cardiome says trial of heart drug was positive - Reuters UPDATE 2-Cardiome says trial of heart drug was positive - Reuters
TORONTO, July 14 (Reuters) - Cardiome Pharma Corp (COM.TO: Quote , Profile , Research , Stock Buzz ) (CRME.O: Quote , Profile , Research , Stock Buzz ) said on Monday an oral version of its vernakalant heart drug reduced the rate at which patients in Source: www.reuters.com Cardiome says trial of heart drug was positive - Guardian Unlimited TORONTO, July 14 (Reuters) - Cardiome Pharma Corp said on Monday an oral version of its vernakalant heart drug reduced the rate at which patients in a study relapsed into irregular heart rhythm, and its shares jumped 28 percent after it announced the Source: www.guardian.co.uk Ranbaxy faces fraud probe by US Food and Drug Administration - Times Online Ranbaxy, India's largest producer of generic drugs, is being investigated by United States officials for alleged fraud that may have led to substandard medicines being sold in the US. The Indian company confirmed that it has been approached by Source: business.timesonline.co.uk FDA OKs ThermoGenesis' MarrowXpress device - MSN MoneyCentral ThermoGenesis Corp. got the OK from the Food and Drug Administration to begin selling a device for separating and storing adult stem cells from bone marrow. The FDA approved the use of the MarrowXpress device in clinical laboratories or for use Source: news.moneycentral.msn.com Reactions mixed on pepper link to salmonella - San Diego Union-Tribune The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are cautioning people at high risk for contracting salmonella to avoid eating raw jalapenos, serrano peppers and fresh cilantro, in addition to certain raw Source: www.signonsandiego.com FDA: Genentech's Avastin Tied To Several Cases Of Anemia - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Monday issued an alert about Genentech Inc.'s (DNA) blockbuster cancer drug Avastin, saying the drug has been tied to the development of anemia in several patients. Several patients Source: money.cnn.com Prosecutors allege Indian drug maker forged documents on quality - USA Today WASHINGTON — Federal prosecutors allege that Indian generic drugmaker Ranbaxy Laboratories deliberately misled the U.S. government about the quality of its low-cost medicines. The Justice Department is demanding Ranbaxy turn over documents it hopes Source: www.usatoday.com FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP - MSN MoneyCentral Amgen Inc. AMGN today announced that the U.S. Food and Drug Administration (FDA) has approved Nplate ™ (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non Source: news.moneycentral.msn.com Ranbaxy faces fraud probe by US Food and Drug Administration - Times Online Ranbaxy faces fraud probe by US Food and Drug Administration - Times Online
Ranbaxy, India's largest producer of generic drugs, is being investigated by United States officials for alleged fraud that may have led to substandard medicines being sold in the US. The Indian company confirmed that it has been approached by Source: business.timesonline.co.uk Cardiome Climbs on Vernakalant Data - Street.Com An experimental drug from Cardiome Pharma CRME reduced the rate of abnormal heart rhythms in patients, according to final results of a midstage study, the company announced Monday. The positive results from the phase IIb study of oral vernakalant Source: www.thestreet.com Amgen gets FDA approval for platelet disorder drug - CNBC Amgen gets FDA approval for platelet disorder drug - CNBC
THOUSAND OAKS, Calif. - Biotechnology company Amgen Inc. said Monday the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition. The drug treats the autoimmune disorder chronic immune Source: www.cnbc.com GlaxoSmithKline: FDA OKs including ADOPT study finding to Avandia - Forbes NEW YORK (Thomson Financial) - GlaxoSmithKline Monday said the Food and Drug Administration has approved the inclusion of clinical findings from a trial of the company's diabetes drug Avandia to the medication's label. The diabetes outcome Source: www.forbes.com Micrus Endovascular gets FDA approval to conduct stent study - CNBC NEW YORK (Thomson Financial) - Micrus Endovascular Corp. Monday said it has received conditional approval from the Food and Drug Administration to conduct a clinical trial for its Vitesse intracranial stent for ischemic therapy. This stent is the Source: www.cnbc.com OncoGenex receives completed Special Protocol Assessment for primary - MSN MoneyCentral VANCOUVER , July 14 /PRNewswire/ - OncoGenex Technologies Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product Source: news.moneycentral.msn.com Ranbaxy shares fall 10 pct on U.S. probe - Reuters India NEW DELHI (Reuters) - Shares in Ranbaxy Laboratories Ltd fell 10 percent on Monday, their biggest drop in 7 years, on concerns a U.S. probe against the drug maker may hit sales in a market responsible for a quarter of its sales. A Ranbaxy spokesman Source: in.reuters.com Ask Dr. H: Frozen food safe forever - Philadelphia Daily News Question: How long can I keep foods in my freezer before they go bad? Answer: The most important factor is the temperature of your freezer. The USDA recommends that freezers remain at a chilly zero degrees Fahrenheit. I suggest that you purchase a Source: www.philly.com UPDATE 1-India's Ranbaxy shares fall 10 pct on U.S. probe - Reuters NEW DELHI, July 14 (Reuters) - Shares in India's Ranbaxy Laboratories Ltd (RANB.BO: Quote , Profile , Research , Stock Buzz ) fell 10 percent on Monday, their biggest drop in 7 years, on concerns a U.S. probe against the drug maker may hit sales in a Source: www.reuters.com Ask Dr. H: Frozen food safe forever - Philadelphia Inquirer Ask Dr. H: Frozen food safe forever - Philadelphia Inquirer
Question: How long can I keep foods in my freezer before they go bad? Answer: The most important factor is the temperature of your freezer. The USDA recommends that freezers remain at a chilly zero degrees Fahrenheit. I suggest that you purchase a Source: www.philly.com Basil joins suspects in U.S. Salmonella outbreak - Xinhua News Agency BEIJING, July 14 (Xinhuanet) -- The U.S. Food and Drug Administration said on Friday that Basil may have joined the list of food suspected in an outbreak of Salmonella food poisoning that has sickened more than 1,000 people. Lucky Green Trading Inc Source: news.xinhuanet.com UPDATE 1-India's Ranbaxy shares fall 10 pct on U.S. probe - Reuters NEW DELHI, July 14 (Reuters) - Shares in India's Ranbaxy Laboratories Ltd (RANB.BO: Quote , Profile , Research , Stock Buzz ) fell 10 percent on Monday, their biggest drop in 7 years, on concerns a U.S. probe against the drug maker may hit sales in a Source: www.reuters.com Myfortic (mycophenolate acid) Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. 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. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. July 13, 2008Indian shares seen lower, Ranbaxy eyed - Reuters India Indian shares seen lower, Ranbaxy eyed - Reuters India
BANGALORE (Reuters) - Indian shares are expected to fall on Monday as investors brace for another round of monetary tightening after inflation quickened to nearly 12 percent, and a mixed Asian market providing little comfort. Political factors will Source: in.reuters.com Pill-popping pets - International Herald Tribune Max retrieves Frisbees. He gobbles jelly beans. He chases deer. He is — and this should be remembered when discussions of cases like his blunder into the thickets of cognitive ethology, normative psychology and intraspecies solipsism — a good dog Source: www.iht.com HPV Vaccine Blamed for Teen's Paralysis - FOX News Gardasil certainly made headlines in 2006 when the Food and Drug Administration approved it as a vaccine against four strains of the human papillomavirus, or HPV, which can cause cervical cancer. HPV can be transmitted sexually, so many parents Source: www.foxnews.com Salmonella fears take zing out of pepper biz - USA Today Imports of jalapeño peppers from Mexico have slowed amid government testing for salmonella, and importers say shortages are likely if the bottleneck continues. "If this goes on for two more weeks, there's a strong likelihood you won't get a Source: www.usatoday.com ARE OUR LEADING PEDIATRICIANS DRUG INDUSTRY SHILLS? - San Francisco Gate Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill. In 1996, for example, Biederman suggested that Source: www.sfgate.com Indian shares open down 1 pct, Ranbaxy falls - Reuters India BANGALORE (Reuters) - Indian shares fell 1 percent at the start on Monday, as investors braced for another round of monetary tightening after inflation quickened to nearly 12 percent. Ranbaxy Laboratories dropped 7.2 percent to 493 rupees after a Source: in.reuters.com 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 Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine
FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. 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's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A 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. Basil joins suspects in U.S. Salmonella outbreak - Reuters Basil joins suspects in U.S. Salmonella outbreak - Reuters
WASHINGTON (Reuters) - Basil may have joined the list of food suspected in an outbreak of Salmonella food poisoning that has sickened more than 1,000 people, the U.S. Food and Drug Administration said on Friday. The FDA said Lucky Green Trading Inc Source: www.reuters.com FDA panel: Epilepsy drugs tied to suicide risk - MSNBC WASHINGTON - Drugs used to treat epileptic seizures can raise suicide risks, but not enough to warrant the strongest warning labels available, a government panel of experts said Thursday. Advisers to the Food and Drug Administration voted 14-4 Source: www.msnbc.msn.com New Intel Health Device Gets FDA Approval - All Headline News Santa Clara, CA (AHN) - A new device that allows patients to communicate with their doctors, get information about their health status, and find out about their condition has received clearance from United States Food and Drug Administration. Intel Source: www.allheadlinenews.com Mexican ministry: FDA study shows Mexican tomatoes not salmonella - Tehran Times MEXICO CITY (Xinhua) -- The Mexican Agriculture Ministry said U.S. health authorities have confirmed that Mexican tomatoes are not the source of the salmonella outbreak in 23 American states, local media reported on Thursday. Mexican Agriculture Source: www.tehrantimes.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, 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. 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. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Child obesity cholesterol treatment spurs debate - Atlanta Journal Constitution Child obesity cholesterol treatment spurs debate - Atlanta Journal Constitution
Last week's recommendation by the American Academy of Pediatrics — that some children as young as 8 with high cholesterol be prescribed statins — has spurred much public debate. But among members of the committee that authored the report, there's Source: www.ajc.com Posts: 3193 - Daily Herald Yea, well so was some of your comments about you and your wife chasing each other around the house naked. I believe in minimal government. While I believe that it is necessary for information to be made available to the public regarding health issues Source: www.heraldextra.com FDA Approves Intel Corp.’s “Health Guide” - eNews 2.0 Intel Corp., the world’s biggest computer chip maker, won clearance from the US Food and Drug Administration (FDA) for “Health Guide,” a an 8lb gadget that functions as a personal health care system. It includes a small touch-screen PC running Source: www.enews20.com 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'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 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. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Radiology and Children: Extra Care Required Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. 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. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. 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. 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. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions 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. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). March 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial April 2008 Monthly Safety Labeling April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Herceptin 440 mg Vials and BWFI Diluent Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. March 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA panel opposes Depakote warning - Chicago Tribune FDA panel opposes Depakote warning - Chicago Tribune
Advisers to the U.S. Food and Drug Administration on Thursday opposed a stepped-up warning about suicide risks from epilepsy drugs, including Abbott Laboratories ' Depakote, saying a heightened alert might cause people to shun treatment they need Source: www.chicagotribune.com U.S. authority seeks documents from India's Ranbaxy - CNBC MUMBAI (Reuters) - The U.S. Food and Drug Administration has filed a motion in a U.S. court seeking documents from Indian drugmaker Ranbaxy Laboratories Ltd Source: www.cnbc.com Newborn dies; not known if drug had role - Corpus Christi Caller One newborn is dead after a Christus Spohn Hospital South pharmacy error that led to as many as 17 babies getting as much as 100 times the recommended dosage of the blood thinner heparin. It's still unclear what role, if any, the heparin played in Source: www.caller.com ARE OUR LEADING PEDIATRICIANS DRUG INDUSTRY SHILLS? - San Francisco Gate Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill. In 1996, for example, Biederman suggested that Source: www.sfgate.com Consumer Briefs - Los Angeles Times High fuel prices are helping sales of products designed to boost gasoline mileage -- even though the government says they're not worth the money. The products include fuel additives and devices that fit inside an engine's air intake valve. Their Source: www.latimes.com US panel rejects strong epilepsy drug warning - Guardian Unlimited BELTSVILLE, Md., July 10 (Reuters) - Anti-seizure drugs for treating epilepsy carry an increased risk of suicidal thoughts and behavior, but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday. Members of the Food Source: www.guardian.co.uk 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. 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. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). 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. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. 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 Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Consumer Briefs - Los Angeles Times Consumer Briefs - Los Angeles Times
High fuel prices are helping sales of products designed to boost gasoline mileage -- even though the government says they're not worth the money. The products include fuel additives and devices that fit inside an engine's air intake valve. Their Source: www.latimes.com Firm thrives making drugs for rare conditions - San Francisco Gate del.icio.us BioMarin Pharmaceutical Inc. is having a good year. Sales of its three approved drugs are on the rise. Even better, the company is poised to become one of those rare biotech companies out there that actually makes money. Yet the Novato Source: www.sfgate.com Patients sue NJ maker of recalled heart drug - Newsday HACKENSACK, N.J. (AP) _ The maker of recalled heart drug Digitek faces at least nine federal lawsuits in New Jersey , including one where a patient died, alleging the drug was dangerous and defective, The lawsuits were filed in U.S. District Court in Source: www.newsday.com Teva Pharma shares fall on drug patent challenge - Boston Globe NEW YORK— Shares of Teva Pharmaceutical Industries Ltd. fell Friday as Momenta Pharmaceuticals Inc. turned the tables on the generic drug developer by challenging the patent on its lucrative multiple sclerosis drug. On Friday, Cambridge, Mass Source: www.boston.com Salmonella found in basil grown in Mexico - Los Angeles Times Salmonella, the bacterium that has sickened more than 1,000 Americans who ate tainted produce since April, has also been found in Thai basil grown in Mexico. The U.S. Food and Drug Administration identified salmonella during random testing of basil Source: www.latimes.com Seizure drugs won't get strong warning - Baltimore Sun WASHINGTON Drugs used to treat epileptic seizures can raise suicide risks, but not enough to deserve the strongest warning labels available, a government panel of experts said yesterday. Advisers to the Food and Drug Administration voted 14-4 against Source: www.baltimoresun.com Today's Globe: drug industry gift rules, skin cancer, AMA apology - Boston Globe The trade association for drug companies announced yesterday a tightening of its voluntary code restricting industry gifts to doctors, even as the association has been forcefully lobbying against a tougher ban that is likely to be debated in the Source: www.boston.com |
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