FDA News Digest September 7, 2004 _____________________________________________________ IN THIS WEEK'S ISSUE -- FDA Advises Consumers on Food Safety in Wake of Hurricane Frances -- Stent OK'd to Help Prevent Stroke by Treating Blocked Neck Artery -- Device Approved to Treat Chest Wall Instability in Children -- FDA Drafts Guidance to Help Reduce Entrapment in Hospital Beds -- Two Plead Guilty to Illegally Distributing Drugs in Florida -- Adverse Reactions Prompt Recall of Heartworm Drug ProHeart 6 -- New Antibiotic Approved to Treat Common Skin Infections in Dogs -- Recalls/Market Withdrawals -- Public Meetings ____________________________________________________________ FDA Advises Consumers on Food Safety in Wake of Hurricane Frances FDA is cautioning consumers affected by Hurricane Frances to take food safety precautions following power outages or flooding. The agency has created a list of tips that advise what to do with food when power goes out, how to handle food when power is restored, and how to maintain food and water safety after flooding. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01311.html Stent OK'd to Help Prevent Stroke by Treating Blocked Neck Artery FDA has approved a stent for use in preventing strokes by opening neck blockages in the carotid artery, the main blood vessel leading to the brain. The device was approved for patients who have had stroke symptoms or whose carotid artery is at least 80 percent blocked and are not good candidates for surgery, the traditional treatment for a blocked carotid artery. http://www.fda.gov/bbs/topics/news/2004/NEW01111.html Device Approved to Treat Chest Wall Instability in Children FDA has approved the Vertical Expandable Prosthetic Titanium Rib, an implanted device to treat children who have thoracic insufficiency syndrome. This disorder involves severe deformities of the chest, spine and ribs that prevent normal breathing and lung development. The device helps straighten the spine and separate the ribs so the lungs can grow and fill with enough air to allow breathing. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01310.html FDA Drafts Guidance to Help Reduce Entrapment in Hospital Beds FDA has published draft guidance for manufacturers to help reduce incidents of patient entrapment in hospital beds. In the last 19 years, the agency has received 575 reports of patient entrapment, which most often occurred among those who are elderly, frail, confused, handicapped, or otherwise vulnerable. FDA is asking for public comments on the guidance. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01309.html Two Plead Guilty to Illegally Distributing Drugs in Florida Two persons have pleaded guilty to charges of operating a Florida drug ring that illegally distributed drugs without requiring prescriptions. One of the persons, Vincent Chhabra, admitted to running a business that operated Web sites and toll-free numbers through which he unlawfully distributed controlled substances. Among the drugs illegally distributed were Viagra, Xenical, Propecia, and Celebrex. http://www.fda.gov/bbs/topics/news/2004/NEW01112.html Adverse Reactions Prompt Recall of Heartworm Drug ProHeart 6 Due to FDA's concerns about the severity and frequency of adverse reactions, some fatal, in dogs treated with the heartworm-prevention drug ProHeart 6, the drug's manufacturer has agreed to stop production of the drug and recall it from the market. FDA is warning veterinarians to avoid treating dogs with this product until further notice. FDA has asked the manufacturer, Fort Dodge Animal Health, to research the cause of the adverse reactions. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01312.html New Antibiotic Approved to Treat Common Skin Infections in Dogs With FDA's approval of Simplicef, veterinarians have a new once-daily antibiotic to treat skin infections (wounds and abscesses) in dogs. The drug was originally approved for human use, but the developer subsequently sought approval for use of the drug in animals. Human drugs are sometimes used legally to treat animals without specific veterinary approval. But because Simplicef has now been evaluated specifically for use in dogs, veterinarians will have specific information on how to administer the drug and assess its results. http://www.fda.gov/bbs/topics/news/2004/NEW01110.html ____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. Medibo Minerva Patient Lifts (mechanical problems) http://www.fda.gov/cdrh/recalls/recall-080404.html Spring House Creamery Creamline Goat Milk (inadequate pasteurization) http://www.fda.gov/oc/po/firmrecalls/creamline09_04.html Dandee Foods' "The Club" sandwich (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/dandee08_04.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ PUBLIC MEETINGS Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. 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