July 12, 2008Radiology 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. 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) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Drug Shortage: MVI Adult Injectable Hospira information updated. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. 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. 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. 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. 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 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 Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ... 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, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. 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... 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. 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. 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. 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. 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 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. 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. 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. 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. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient. 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 Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. 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. July 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. 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. 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 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 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. 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... Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the information ... 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. Is dental mercury a threat to health? - Baltimore Sun Is dental mercury a threat to health? - Baltimore Sun
I was disturbed by the way The Sun 's article on dental amalgam portrayed this restorative material ("Fighting Tooth and Nail," July 3). The article mentioned that there is little scientific evidence to support Moms Against Mercury's claims about the Source: www.baltimoresun.com US, Europe, Australia unite on drug inspections - FOX News WASHINGTON — Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush Source: www.foxnews.com UPDATE: FDA Panel Rejects Tough Warnings For Epilepsy Drugs - CNN Money BELTSVILLE, Md. -(Dow Jones)- A Food and Drug Administration panel on Thursday did not recommend adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high enough risk for suicidal behavior. The move could be Source: money.cnn.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 Pfizer argues against epilepsy drug warning - Reuters Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The Source: www.reuters.com Waging the water-bottle battle - Seattle Times Activists, governments and the bottled-water industry have engaged in a giant water fight for the past two years, extensively reported by the media. By now, many consumers know that the mass marketing of water in single-use bottles has environmental Source: seattletimes.nwsource.com Salmonella found in basil from Mexico - Boston Globe WASHINGTON - A strain of salmonella, the bacteria that has sickened more than 1,000 Americans who ate tainted produce since April, has been found in Thai basil grown in Mexico. The Food and Drug Administration identified salmonella during random Source: www.boston.com Study Links Epilepsy Drug To Suicidal Thoughts - NPR News Morning Edition , July 10, 2008 · The Food and Drug Administration is considering beefing up its warnings about the relationship between anti-epileptic drugs and suicide. Its staffers have analyzed 199 studies and found that the drugs increase the Source: www.npr.org Lake Country Lamb Feed Voluntary Recall (June 6) Lake Country Lamb Feed Voluntary Recall (June 6)
The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. 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. 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. 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. 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. 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. 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. 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. 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. Stay Healthy While Traveling Abroad 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. 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. 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 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. 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. 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 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. July 11, 2008Patients Sue N.J. Maker of Recalled Heart Drug - Law.com Patients Sue N.J. Maker of Recalled Heart Drug - Law.com
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 Newark in recent months Source: www.law.com Cipro, similar antibiotics to get 'black box' warning - Wave 3 WASHINGTON (AP) - Drug safety officials are calling for an urgent safety warning for Cipro and similar antibiotics. The Food and Drug Administration is ordering the "black box" wording due to evidence the drugs may lead to tendon ruptures. They say Source: www.wave3.com Mexico says tests found no salmonella in Mexican tomatoes - Dallas Morning News MEXICO CITY – Mexico's Agriculture Department says its tests found no salmonella in Mexican tomatoes. It says Mexican officials took samples from the same soil, water and tomatoes recently examined by U.S. inspectors and found no evidence of the Source: www.dallasnews.com Pfizer argues against epilepsy drug warning - Reuters BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The Source: www.reuters.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 Intel gets FDA clearance on in-home medical device - Boston Globe SANTA CLARA, Calif.— Chip maker Intel Corp. said Thursday it received market clearance from the U.S. Food and Drug Administration for its in-home personal health system. The Intel Health Guide is a care management tool for health care professionals Source: www.boston.com Mexico finds no salmonella in tomatoes - Salon It says Mexican officials took samples from the same soil, water and tomatoes recently examined by U.S. inspectors and found no evidence of the bacteria. A team of inspectors from the U.S. Food and Drug Administration visited five Mexican farms in Source: www.salon.com Butkus says 'roid use in football embarrassing - NBC Sports Hall of Famer Dick Butkus, center, who spoke to more than 200 students at a Soldier Field rally on Friday, on steroids: "I owe everything to football. I'm embarrassed that for some other kid, it won't be as pure as when I was able to play.'' CHICAGO Source: nbcsports.msnbc.com Salmonella found in basil from Mexico - Boston Globe WASHINGTON - A strain of salmonella, the bacteria that has sickened more than 1,000 Americans who ate tainted produce since April, has been found in Thai basil grown in Mexico. The Food and Drug Administration identified salmonella during random Source: www.boston.com Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial
Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 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. 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. 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). 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. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. FDA 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. 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. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. 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: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. New 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... Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because the 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. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. 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. 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. 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) 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. Science New "Cheerful" Intel Home Health Device Wins FDA Approval - DailyTech Science New "Cheerful" Intel Home Health Device Wins FDA Approval - DailyTech
Intel is known best for its microprocessors , as it currently owns around 80 to 90 percent of the market . However, the company has made efforts to diversify into graphics and even more exotic offerings. Around the lines of its more unique offerings Source: www.dailytech.com FDA OKs In-Home Medical Device for Management of Health Conditions - HULIQ.com Intel Receives FDA Market Clearance on In-Home Medical Device for Management of Health Conditions. The Intel® Health Guide Connects Patients and Their Care Teams for Personalized Care Management at Home. SANTA CLARA, Calif., July 10, 2008 – Intel Source: www.huliq.com FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs - Atlanta Journal Constitution THURSDAY, July 10 (HealthDay News) -- Anti-seizure drugs can cause increased suicidal tendencies in patients, but not enough to warrant the government's strongest warning label on them, a U.S. health advisory panel concluded Thursday. The 20-member Source: www.ajc.com AngioDynamics issues product recall pending FDA review - MSN MoneyCentral AngioDynamics, Inc. is voluntarily recalling all hospital inventory of Centros, a catheter used in dialysis. The Queensbury, N.Y.-based medical device manufacturer said it became aware that the catheter cuff, a component intended to anchor the Source: news.moneycentral.msn.com FDA Approves Intel's Home Health Monitoring System - eMaxHealth.com FDA approved a new home health monitoring device from Intel. It is called Health Guide. This home health monitoring device is easy to use and aimed at helping those with chronic health conditions, who need to monitor health regularly. Intel's Home Source: www.emaxhealth.com FDA Panel: No Black Box Warning for Epilepsy Drugs - Wired An FDA advisory panel has recommended against putting "black box" warnings on epilepsy drugs linked to a small increased risk of suicide . Though the panel's 14-4 vote is not binding, it will likely be heeded by the FDA. Doctors will, however, be Source: blog.wired.com FDA Told to Skip ‘Black Box’ on Epilepsy Drugs and Suicide - Wall Street Journal Until yesterday, the FDA had been rolling steadily toward slapping a black-box warning on epilepsy drugs because they may increase the risk of suicidal thoughts and behaviors. But a committee of outside experts convened by the FDA thinks that’s a Source: blogs.wsj.com Diabetes linked to male infertility - United Press International Insulin resistance ups breast cancer risk U.S. diabetes up 3 million in two years Vitamins may help diabetic memory slumps FDA may change rules for diabetes drugs Possible cause of late-onset disease found Diabetic dietary adherence effective Source: www.upi.com Epilepsy Drugs May Avoid Black Box - Wall Street Journal Epilepsy Drugs May Avoid Black Box - Wall Street Journal
BELTSVILLE, Md. -- A Food and Drug Administration panel has recommended against adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high-enough risk for suicidal behavior to warrant such warnings. The move Source: online.wsj.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 Salmonella probe puzzles investigators - Detroit Free Press Salmonella probe puzzles investigators - Detroit Free Press
Jalapeno pepper producers are being probed alongside tomato distributors, and fresh cilantro also is under suspicion in what's become the nation's largest food-borne outbreak in at least a decade. Source: www.freep.com 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. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. 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) 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: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. 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. 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. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions 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. July 10, 2008U.S. advisers reject strong epilepsy drug warning - MSN UK News U.S. advisers reject strong epilepsy drug warning - MSN UK News
BELTSVILLE, Maryland (Reuters) - Anti-seizure drugs used to treat epilepsy carry an increased risk of suicidal thoughts and behaviour but not enough to warrant a black box warning, a U.S. advisory panel concluded on Thursday. Members of the Food and Source: news.uk.msn.com Panel rejects strong epilepsy drug warning - Reuters BELTSVILLE, Maryland (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 and Source: www.reuters.com Lighting A Path To Drug Discovery - Forbes Instead of buying a biotech with drugs already in human trials, some of pharma's biggest players are starting from scratch. In recent years pharmaceutical firms have learned the hard way that developing new drugs doesn’t always mean those drugs Source: www.forbes.com FDA orders Cipro warning - Los Angeles Times FDA orders Cipro warning - Los Angeles Times
Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they might lead to serious tendon ruptures that could leave patients incapacitated and needing extensive surgery Source: www.latimes.com FDA Panel: No Black Box Warning On Epilepsy Drugs - KSDK WASHINGTON (AP) -- 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.ksdk.com FDA Panel Recommends Against Adding Warnings to Epilepsy Drugs - Wall Street Journal BELTSVILLE, Md. -- A Food and Drug Administration panel on Thursday did not recommend adding the agency's toughest warnings to labels of epilepsy drugs, saying studies didn't show a high enough risk for suicidal behavior. The move could be a boon to Source: online.wsj.com Intel's in-home health device gets FDA nod - CNET News The new Intel Health Guide --which collects vital signs and allows for remote interactions between patient and doctor--may soon make its way into the homes of consumers with chronic health conditions such as diabetes and congestive heart failure. The Source: news.cnet.com Epilepsy Drugs Don't Need Strict Warnings, Panel Says (Update2) - Bloomberg July 10 (Bloomberg) -- Epilepsy drugs shouldn't get the strictest U.S. warning about suicide risks because the alert may cause people to shun treatment they need, advisers said. The Food and Drug Administration advisory panel agreed with the agency's Source: www.bloomberg.com New Epilepsy Warnings Sought By FDA - Overthelimit.info Washington, D.C.- There are warnings that are featured on the packages of epilepsy medications at the current time, but the federal supervising agency overseeing them wants to seriously strengthen the type and intensity of the warnings. The Food and Source: www.overthelimit.info Intel gets FDA OK for personal health system - San Diego Union-Tribune CHICAGO – Intel Corp, the world's biggest computer chip maker, Thursday won clearance from the Food and Drug Administration to sell an in-home health monitoring system for patients with chronic conditions. The system, called Health Guide, combines Source: www.signonsandiego.com US panel rejects strong epilepsy drug warning - Forbes BELTSVILLE, Md. (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 Thursday. Members of the Food and Drug Source: www.forbes.com UPDATE 1-Pfizer argues against epilepsy drug warning - Reuters UPDATE 1-Pfizer argues against epilepsy drug warning - Reuters
BELTSVILLE, Md., July 10 (Reuters) - Pfizer Inc (PFE.N: Quote , Profile , Research , Stock Buzz ) said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications Source: www.reuters.com No China Trips by U.S. Food Inspectors - CNS News (CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji Source: www.cnsnews.com FDA Holds Hearings on Epilepsy Drug Suicide Risk - Wired The potential suicide risk posed by eleven popular epilepsy drugs is the subject of a hearing held today by the U.S. Food and Drug Administration. An FDA analysis of 199 studies showed that .43 percent of people taking the drugs committed suicide or Source: blog.wired.com Pfizer denies suicide risks with epilepsy drugs - Forbes Pfizer Inc. told government officials Thursday its drug Lyrica should not receive stern warnings about suicide risks that regulators are advocating for all epilepsy drugs. The world's largest drug maker defended the safety of its blockbuster Source: www.forbes.com FDA issues warning on Cipro, similar antibiotics - Washington Post WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and Source: www.washingtonpost.com Pfizer argues against epilepsy drug warning - Reuters BELTSVILLE, Maryland (Reuters) - Pfizer Inc said its epilepsy drugs do not increase the risk of suicidal behavior and should be exempt from tougher warnings being sought for similar medications, despite concerns from U.S. health regulators. The Source: www.reuters.com 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. 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. 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. 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. 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. Drug Shortage: MVI Adult Injectable Hospira information updated. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 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. CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes
Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com Lutronic Announces FDA Clearance and Immediate Availability of its - Forbes Lutronic, Inc., one of the world's leading developers and manufacturers of aesthetic and medical laser systems, announced today that it has received regulatory clearance from the U.S. FDA (Food and Drug Administration) for the eCO2 system. Using the Source: www.forbes.com A Drug Safety Warning That Could Harm - ABC News Ironic, but true -- some doctors are worried about the dangers of the Food and Drug Administration's latest safety effort concerning a class of epilepsy drugs. FDA staff is recommending the agency require a warning to highlight suicide risk on Source: www.abcnews.go.com Intel Receives FDA Market Clearance on In-Home Medical Device for - MSN MoneyCentral Intel Corporation today announced the receipt of 510(k) market clearance from the U.S. Food and Drug Administration (FDA) on Intel ’ s personal health system, the Intel ® Health Guide, a care management tool for healthcare professionals who manage Source: news.moneycentral.msn.com Outbreak: Salmonella linked to tomatoes has FDA baffled - Danbury News-Times The national salmonella outbreak linked to tomatoes has now reached 1,017 confirmed cases -- with four in Connecticut and 28 in New York. That makes this the worst outbreak of illness due to food contamination in years, and federal health officials Source: www.newstimes.com FDA issues warning on Cipro, similar antibiotics - Washington Post WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and Source: www.washingtonpost.com How to Dispose of Unused Medicines How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. ViroPharma: FDA committee will have generics focus - MSN MoneyCentral ViroPharma: FDA committee will have generics focus - MSN MoneyCentral
EXTON, Pa. (AP) - ViroPharma Inc. said Tuesday an upcoming Food and Drug Administration advisory committee meeting will focus on general generic drug issues and not specifically on the company's only marketed treatment, Vancocin. Wall Street has been Source: moneycentral.msn.com 1,000 sickened in salmonella outbreak - Chicago Tribune WASHINGTON — Salmonella poisoning has sickened more than 1,000 people in 41 states, the District of Columbia and Canada, and federal health officials have now linked jalapeno and serrano peppers to the outbreak. Illinois has reported 100 salmonella Source: www.chicagotribune.com FDA orders 'black box' label on some antibiotics - CNN (CNN) -- The U.S. Food and Drug Administration Tuesday ordered the makers of certain antibiotics to add a "black box" label warning -- the FDA's strongest -- to alert patients of possible tendon ruptures and tendonitis. Cipro is one of the drugs for Source: www.cnn.com Eurand Names Bill Newbould Vice President, Investor Relations - MSN MoneyCentral PHILADELPHIA, July 10, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug Source: news.moneycentral.msn.com CORRECT: EXACT SCIENCES TIMING TO ALLOW FOR POTENTIAL FDA CLEARANCE IN - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com UPDATE 1-FDA OKs Invitrogen genetic test for breast cancer - Reuters WASHINGTON, July 8 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's (IVGN.O: Quote , Profile , Research , Stock Buzz ) genetic test for determining whether patients with breast cancer are good candidates for Source: www.reuters.com Exact Sciences Provides Regulatory Update for Its Version 2 Stool - MSN MoneyCentral EXACT Sciences Corporation EXAS today announced that it has confirmed with the U.S. Food and Drug Administration (FDA) the clinical performance characteristics and the minimum number of average-risk cancer samples that will be required for validation Source: news.moneycentral.msn.com 1,000 sickened in salmonella outbreak - Chicago Tribune 1,000 sickened in salmonella outbreak - Chicago Tribune
WASHINGTON — Salmonella poisoning has sickened more than 1,000 people in 41 states, the District of Columbia and Canada, and federal health officials have now linked jalapeno and serrano peppers to the outbreak. Illinois has reported 100 salmonella Source: www.chicagotribune.com Exact Sciences Provides Regulatory Update for Its Version 2 Stool - MSN MoneyCentral EXACT Sciences Corporation EXAS today announced that it has confirmed with the U.S. Food and Drug Administration (FDA) the clinical performance characteristics and the minimum number of average-risk cancer samples that will be required for validation Source: news.moneycentral.msn.com FDA issues warning on Cipro, similar antibiotics - Washington Post WASHINGTON -- Federal drug safety officials have imposed the government's most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and Source: www.washingtonpost.com 4 out of 5 sunscreens inadequate, study finds - San Francisco Gate del.icio.us When temperatures soar past the century mark around the Bay Area, people head for the beach with all of the usual gear in tow. Think towels, Frisbees, coolers, umbrellas. And sunscreen. Oceans of it. Americans will spend more than $1.1 Source: www.sfgate.com Insmed Announces First Human Bioequivalence Data for a Follow-on - MSN MoneyCentral Company Intends to Request Meeting with FDA Regarding Possible Phase III Trial Based on Human Data Demonstrating Bioequivalence of INS-19 to Neupogen(R) RICHMOND, Va., July 10, 2008 /PRNewswire-FirstCall/ -- Insmed Inc. INSM , a developer of follow Source: news.moneycentral.msn.com FDA OKs Invitrogen genetic test for breast cancer - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Invitrogen Corp's genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin. Invitrogen's test, the SPOT Source: www.reuters.com FDA calls for urgent warning on tendon risks - Boston Globe WASHINGTON— Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and Source: www.boston.com FDA calls for - MSNBC WASHINGTON - Federal drug safety officials have imposed the government’s most urgent warning on Cipro and similar antibiotics, citing risks that they can cause tendon ruptures, a serious injury that leaves some patients incapacitated. The Food and Source: www.msnbc.msn.com FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs 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. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA 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 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 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. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. 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. 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. 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. Drug firms give millions to Vt. doctors - Brattleboro Reformer Drug firms give millions to Vt. doctors - Brattleboro Reformer
BRATTLEBORO -- Pharmaceutical companies increased the amount of money given to doctors in the state last year, despite Vermont's law that requires disclosure of the gifts. Drug companies gave out more than $3 million in 2007 to Vermont physicians Source: www.reformer.com U.S. unites with Europe, Australia on drug inspections - Los Angeles Times WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries such as China and India that make an increasing share of the active ingredients in medications Source: www.latimes.com Jalapeños now eyed in salmonella probe - Newsday Jalapeño peppers and salmonella-tainted tomatoes may have been grown on the same farm or the two intermingled somewhere in produce-distribution channels on their way to consumers, federal health experts said yesterday as they attempted to explain Source: www.newsday.com US futures point to mild rise; techs fall in Europe - Reuters UK * U.S. stock futures point to a modest recovery at the start of trade. September Dow Jones DJU8, Standard & Poor's and Nasdaq 100 futures are up between 0.2 and 0.3 percent by 0915 GMT. U.S. benchmark indexes .DJI .SPX .IXIC fell by more than 2 Source: uk.reuters.com US Food Inspectors Made No Trips to China Last Year - CNS News (CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji Source: www.cnsnews.com Congress on drug money - Times-Argus On Monday, the American Association of Pediatrics promoted using anti-cholesterol statin drugs in children as young as 8 years of age, essentially turning them into guinea pigs for an experimental treatment. On Wednesday, the Senate reversed itself Source: www.timesargus.com July 9, 2008Ability to track foods limited - St. Petersburg Times Ability to track foods limited - St. Petersburg Times
More than 1,000 people in 41 states and the District of Columbia have now been sickened in the nation's salmonella outbreak, in what officials said Wednesday was the largest food-borne outbreak in the last decade. And some food safety experts this Source: www.tampabay.com FDA changing notices on drug decisions - Reuters WASHINGTON (Reuters) - U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved, the Food and Drug Administration said on Wednesday. Companies have been receiving "approvable letters" indicating a Source: www.reuters.com Merck, FDA expand Gardasil warnings - The Washington Times Merck & Co. and the Food and Drug Administration in June expanded the possible adverse reactions for Gardasil , the widely advertised cervical cancer vaccine for girls and young women, to include joint and muscle pain, fatigue, physical weakness and Source: washingtontimes.com FDA approves revolutionary laser for wide-use pain relief - Asheville Citizen-Times ASHEVILLE – Dr. Dru’s Chiropractic, Dru Aguilar, 438 Montford Ave., announces the Food and Drug Administration’s (FDA) approval of the Erchonia3LT laser to use for pain relief in patients suffering from chronic and acute pain. The laser Source: www.citizen-times.com FDA to boost suicide risk warnings - Political Gateway WASHINGTON, July 10 (UPI) -- The U.S. Food and Drug Administration is expected Thursday to recommend black-box warnings on suicide risk for 11 epilepsy drugs. The agency has put warnings about suicidality --suicide risk and suicidal behavior-- on Source: www.politicalgateway.com FDA Approves Genetic Test for Breast Cancer - BusinessWeek TUESDAY, July 8 (HealthDay News) -- A genetic test to determine whether a breast cancer patient is likely to respond to treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration. The SPOT-Light HER2 Source: www.businessweek.com US, Europe, Australia unite on drug inspections - Chicago Tribune WASHINGTON - Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications. Bush Source: www.chicagotribune.com Intel gets FDA OK for personal health system - Reuters Intel gets FDA OK for personal health system - Reuters
CHICAGO, July 10 (Reuters) - Intel Corp (INTC.O: Quote , Profile , Research , Stock Buzz ), the world's biggest computer chip maker, said on Thursday it won clearance from the U.S. Food and Drug Administration to sell a personal in-home health Source: www.reuters.com U.S. looks to jalapenos in Salmonella outbreak - Reuters India WASHINGTON (Reuters) - More than 1,000 people have been sickened in an outbreak of Salmonella food poisoning and federal officials said on Wednesday they now suspected several causes, including jalapeno peppers. Since April, 1,017 people in 41 states Source: in.reuters.com US Food Inspectors Made No Trips to China Last Year - CNS News (CNSNews.com) - U.S. Food and Drug Administration inspectors made 13 visits to Fiji in 2007 for food inspections and no visits at all to China, according to a study released to Congress recently by the Government Accountability Office (GAO). Fiji Source: www.cnsnews.com Ability to track foods limited - St. Petersburg Times More than 1,000 people in 41 states and the District of Columbia have now been sickened in the nation's salmonella outbreak, in what officials said Wednesday was the largest food-borne outbreak in the last decade. And some food safety experts this Source: www.tampabay.com International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29)
International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. FDA 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. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA 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 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. 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. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. U.S. unites with Europe, Australia on drug inspections - Los Angeles Times U.S. unites with Europe, Australia on drug inspections - Los Angeles Times
WASHINGTON -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries such as China and India that make an increasing share of the active ingredients in medications Source: www.latimes.com FDA Asks For Urgent Warning - KELOLAND TV A common class of antibiotics has gained the strongest ranking from the Food and Drug Administration - but it isn't one they are proud to have earned. The FDA is asking the drug makers of certain common antibiotics used to treat basic bacterial Source: www.keloland.com FDA calls for urgent warning on tendon risks - Public Opinion WASHINGTON—Drug safety officials Tuesday imposed the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing Source: www.publicopiniononline.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. 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. 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. 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. Pet Food Products Seized at PETCO Distribution Center |
