FDA News Digest December 22, 2003 Note to Subscribers: FDA News Digest is taking a holiday break the week of Dec. 29. We wish all our subscribers happy holidays, and we'll return to your e-mailbox Jan. 5. ______________________________________________________________ DNA Tests Approved for Gauging Risk of Blood Clotting Abnormalities FDA has approved two test kits that will allow clinical laboratories to identify people at risk of developing blood clots in the veins of their legs and elsewhere because of hereditary clotting abnormalities. The products are the first DNA-based lab tests for an inherited disorder. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00998.html ______________________________________________________________ Doctors Updated on Risks Related to Abdominal Aneurysm Stent Emphasizing that AneuRx Stent Grafts "remain safe and effective," FDA has updated earlier information about the mortality risk associated with use of these stents, used to prevent rupture of abdominal aortic aneurysms.. Based on clinical trial results, FDA estimates a 2.7 percent aneurysm-related death rate three years after patients were implanted with the stent. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01272.html Public health notification: http://www.fda.gov/cdrh/safety/aneurx.html ______________________________________________________________ Health Professionals Alerted About Counterfeit Hernia Repair Mesh FDA is alerting health professionals about a counterfeit version of the Prolene polypropylene mesh, used in hernia repair and other surgery. Preliminary testing has shown that some samples are not sterile. The agency hasn't determined if the counterfeit devices are still being marketed. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01274.html Public health notification: http://www.fda.gov/cdrh/safety/121903.html ______________________________________________________________ FDA Issues Tips for Preventing Hospital Bed Fires FDA has issued a list of tips for hospitals and other medical facilities to help prevent fires in electrically powered hospital beds. The agency has received 95 reports of hospital bed fires since 1993. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01273.html Safety tip list: http://www.fda.gov/cdrh/safety/bedfires.html ______________________________________________________________ 13 Indicted in Maryland Oxycontin Drug Trafficking Ring Following a two-year investigation by FDA and several other federal, state and local agencies, a federal grand jury has indicted 13 people on charges that they used fraudulent prescriptions to obtain Oxycontin and other prescription drugs from Maryland pharmacies for resale on the street. http://www.fda.gov/bbs/topics/NEWS/2003/dojoxycontinprfinal.pdf ______________________________________________________________ Pet Turtles Pose Salmonella Risk for Infants and Small Children FDA is urging consumers not to buy live baby turtles with a shell less than four inches long because they could put infants and small children at risk of salmonella infection. Though FDA banned sales of these turtles in 1970, the agency has learned that malls in the Houston area have been selling them. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00997.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Betty Crocker Triple Chunk Brownie Mix; limited number of 21.2 oz. packages (undeclared pecans) http://www.fda.gov/oc/po/firmrecalls/generalmills12_03.html Country Dairy Eggnog (possible inadequate processing) http://www.fda.gov/oc/po/firmrecalls/countrydairy12_03.html Hansen Beverage Co. Classic Sparkling Cider; 50.7 oz. Magnum glass bottles (some bottles broken) http://www.fda.gov/oc/po/firmrecalls/hansen12_03.html Hood Cultured Fat-Free Buttermilk (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/hood12_03.html Sedef Bakery Baklava, Sesame Sticks, Assorted Cookies, and Kurupasta (undeclared nuts, dairy products and eggs) http://www.fda.gov/oc/po/firmrecalls/sedef12_03.html Peregrina Queso Fresco Fresh Cheese (possible Listeria contamination) http://www.fda.gov/oc/po/firmrecalls/peregrina12_03.html ______________________________________________________________ RECENT SPEECHES FDA Commissioner Mark B. McClellan, M.D., before the European Federation for Pharmaceutical Sciences Conference, Basel, Switzerland (Dec. 8) http://www.fda.gov/oc/speeches/2003/eufeps1208.html ______________________________________________________________ PUBLIC MEETINGS For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ______________________________________________________________ HOW'S YOUR KNOWLEDGE of health-related topics such as heart disease, genetically engineered foods, and menopausal hormone therapy? Find out by taking our quiz at http://www.fda.gov/fdac/quiz/onlinequiz14_js.html. ______________________________________________________________ To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
