FDA News Digest December 1, 2003 ______________________________________________________________ New Drug OK'd for Treating Advanced Prostate Cancer FDA has approved the marketing of Plenaxis (abarelix), a drug for advanced prostate cancer for patients who have no alternative therapy. The drug will be marketed under a voluntary risk management program agreed to and administered by the sponsor that will restrict the use of Plenaxis to patients with advanced prostate cancer who have no alternative therapy because of an increased risk of serious and potentially life-threatening allergic reactions associated with its use. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01268.html ______________________________________________________________ FDA Updates Adverse Event Information for Cordis Coronary Stent FDA has updated the notice it sent to physicians in October about reports of clotting and hypersensitivity in patients receiving the Cordis Cypher Coronary Stent. The stent is a drug-treated mesh cylinder implanted in patients undergoing angioplasty to open clogged coronary arteries. After a review of clinical studies, the agency says clotting is within the expected rate, and hypersensitivity problems tend to be minor. FDA emphasizes that the Cordis stent is safe and effective when used according to the label. Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01267.html More information: http://www.fda.gov/cdrh/safety/cypher2.html ______________________________________________________________ FDA Calls Appeals Court Denial to Rx Depot Motion a 'Clear Signal' FDA says that a recent Circuit Court of Appeals ruling to deny foreign drug importer Rx Depot a motion to stay an earlier District Court's ruling shutting down the firm is a "clear signal" that other businesses importing medicines illegally "will not be allowed to threaten the public health." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00983.html ______________________________________________________________ FDA Advises Oregon Consumers about Possible Salmonella Contamination of Raw Sprouts Following a reported six cases of Salmonella in Oregon possibly linked to raw sprouts, FDA is repeating its earlier advice about eating raw sprouts. People at high risk of developing foodborne illness, including children, the elderly, and those with weakened immune systems, should not eat raw sprouts. Others who wish to reduce their risk of illness should also avoid raw sprouts. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00984.html ______________________________________________________________ Contaminated Food Seized at Washington, D.C., Warehouse At FDA's request, U.S. marshals have seized scores of containers of food at Washington, D.C.-based Phoenix Enterprises, after the company repeatedly ignored warnings from the agency that the company needed to take steps to avoid rodent infestation and contamination of stored food products. The company distributes dried oriental noodles and other dried food products. http://www.fda.gov/bbs/topics/news/2003/doj112803.html ______________________________________________________________ FDA Commissioner Praises Senate Action on Public Health Measures FDA Commissioner Mark B. McClellan, M.D., has issued a statement thanking several U.S. senators for their leadership in recent actions on public health bills. McClellan applauded Senate committee work related to food labeling for consumers with allergies, new animal therapies, mammography standards, and medical device user fees. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00982.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled or withdrawn for the reasons shown. Go to the linked page for more information. Apio Fresh, LLC Green Onions (possible link to hepatitis A) http://www.fda.gov/oc/po/firmrecalls/apio11_03.html Harmony Farms Alfalfa Sprouts; several varieties and sizes (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/harmony11_03.html Kien Import Corp. Evergreen Melon Candy (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/meloncandy11_03.html Malatya Dried Apricots (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/malataya11_03.html KB Specialty Foods Deli Chef Sour Cream & Cheese Macaroni Salad (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/kbspecialty11_03.html For an archive of FDA-related recalls and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ RECENT TESTIMONY FDA Associate Commissioner for Regulatory Affairs John M. Taylor III, before the Senate Committee on Commerce, Science and Transportation (Nov. 20) http://www.fda.gov/ola/2003/rxdrugs1120.html FDA Deputy Commissioner Lester M. Crawford, D.V.M., before the Senate Committee on Governmental Affairs (Nov. 19) http://www.fda.gov/ola/2003/counterterrorism1119.html For an archive of testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be December 8. 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
