FDA News Digest April 14, 2003 ______________________________________________________________ American Red Cross Agrees to Revised Blood Safety Provisions The American Red Cross has agreed to substantial revisions to a 1993 consent decree that addresses FDA's concerns about persistent, serious violations of blood safety rules. The revisions provide clear deadlines for completing decree requirements and eliminating new violations observed since the original decree was signed. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00891.html ______________________________________________________________ New Drug Regimen May Improve Transplanted Kidney Function FDA has approved new labeling for the anti-rejection drug Rapamune (sirolimus) that will allow new kidney transplant patients at low-to-moderate risk of organ rejection to stop taking cyclosporine, another anti-rejection drug, two to four months after transplantation. Taking patients off cyclosporine in this early timeframe may improve kidney function, the agency says. About half of all new kidney transplant patients may benefit from the new regimen. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01211.html _______________________________________________________________ FDA to Examine Combination Products Used to Treat Hot Flashes FDA is examining the effectiveness of estrogen/androgen combination products used to treat hot flashes associated with menopause. The agency does not believe there is sufficient evidence to show that androgens contribute to the effectiveness of these products when used to treat hot flashes in women who do not find relief from estrogen products alone. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01210.html ________________________________________________________________ FDA's 2001 Advisory on Methylmercury in Fish Unchanged Contrary to recent news reports, FDA has not revised its 2001 advisory regarding certain types of seafood. The agency continues to recommend that pregnant women and women of childbearing age who may become pregnant should not eat shark, swordfish, king mackerel, or tilefish because they may contain high levels of methylmercury. FDA also advises nursing mothers and young children to avoid these fish. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01209.html ________________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: Vinarol Tablets (unlabeled drug ingredient) http://www.fda.gov/medwatch/SAFETY/2003/vinarol.htm Easy-Bake's Bake 'n Design Cookie Sets (undeclared peanuts and milk proteins) http://www.fda.gov/oc/po/firmrecalls/cookie_easybake04_03.html Indumar Seafood's Caribe Brand Fresh Crab Claw Meat (possible contamination with Listeria monocytogenes) http://www.fda.gov/oc/po/firmrecalls/indumar04_03.html Swatt Baking Co. Salt Rising Bread (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/bread_swatt04_03.html Rhee Bros. Chamdel Brand Korean Cookies (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/chamdel_rhee04_03.html Sincere Trading Co. Dragon Sweetened Coconut (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/sincere04_03.html ________________________________________________________________ PUBLIC MEETINGS FDA Commissioner McClellan to be Featured at 2003 Science Forum FDA Commissioner Mark B. McClellan, M.D., will headline the 9th Annual FDA Science Forum in Washington, D.C., April 24-25. Open to the public, the forum brings FDA scientists together with industry, academia, consumers, and others to share information about the science-based mission of the agency. Discussion topics for this year include risk assessment, cancer treatments, and public health initiatives in the wake of 9/11/01. http://www.dcscienceforum.org 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 the FDA News Digest. Our next posting will be April 21. 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
