FDA News Digest November 3, 2003 ________________________________________________ FDA Draft Assessment Indicates Food from Animal Clones Is Safe FDA has released a summary of a draft assessment stating that food from animal clones and their offspring is likely to be as safe as that from non-clones. The assessment is part of an ongoing review of scientific evidence regarding the safety of food products derived from animal clones. Studies have shown that healthy adult clones are virtually indistinguishable from their conventional counterparts. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00968.html _____________________________________________________________ FDA Warns Doctors About Side Effects of Drug-Coated Stent FDA has advised doctors of reports the agency has received linking the Cordis Corp. Cypher Coronary Stent to more than 60 deaths and more than 200 serious adverse effects. The stent is a tiny mesh cylinder coated with a slow-release drug that is implanted in clogged coronary arteries after the vessels are opened by angioplasty. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01257.html ______________________________________________________________ Agency Advises Doctors About Possible Link Between Antidepressants and Suicide Potential in Children FDA is advising medical professionals that the agency has received reports of suicidal thinking and suicidal attempts in pediatric patients involved in clinical studies of several antidepressants administered to treat major depressive disorder. Though studies of the drugs to date have shown no definitive link to suicide potential, FDA officials say this possibility cannot be ruled out. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01256.html ______________________________________________________________ New Food Tests Help Protect Those with Deadly Peanut Allergy FDA has collaborated with the Association of Official Analytical Chemists to approve several testing methods for detecting peanuts in foods such as breakfast cereal, cookies and ice cream. The tests will allow the food industry to determine if peanuts are present in foods not labeled as containing peanuts, an important advance because peanuts can cause serious allergic reactions in some people. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01258.html ______________________________________________________________ FDA Calls Steroid Alternative THG an Unapproved Drug FDA has determined that the substance tetrahydrogestrinone (THG), sometimes marketed as a dietary supplement and reportedly used as a steroid alternative to improve athletic performance, is an unapproved drug that is potentially harmful. As such, it cannot be marketed legally without FDA's formal approval. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00967.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. Uncle Charlie's Apricot Muffin Mix (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/unclecharlie10_03.html Daifuku Trading Corp. Kasugai/Rakka Senbei (Japanese cookies) (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/Daifuku10_03.html Hegedorn's Supermarket Sugar-Free Golden Pound Cake (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/poundcake10_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, before the Senate Committee on Commerce (Oct. 28) http://www.fda.gov/ola/2003/dietarysupplements1028.html For an archive of testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ PUBLIC MEETINGS Nov. 4 -- Veterinary Medicine Advisory Committee; Rockville, Md. http://www.fda.gov/oc/advisory/accalendar/cvm12548ddd1103040503amd.html Nov. 12 -- FDA Public Workshop on Clinical Trial Endpoints in Colorectal Cancer; Washington, D.C. http://www.fda.gov/cder/drug/cancer_endpoints/colonAnnouncement.pdf Nov. 20 -- FDA Workshop: Exploring the Link Between Food Labeling and Weight Management; Bethesda, Md. https://secure.z-techcorp.com/cmt/meetings/meeting_detail.cfm?meeting_id=26 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. Our next posting will be November 10. 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
