FDA News Digest September 20, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- FDA Supports Advisory Panels' Recommendations on Antidepressants in Children -- OTC Sale OK'd for Device to Restore Heart Rhythm After Cardiac Arrest -- FDA Approves Implanted Lens That Corrects Nearsightedness -- Latest FDA Consumer Magazine Available Online -- Recalls/Market Withdrawals -- Congressional Testimony -- Public Meetings ____________________________________________________________ FDA Supports Advisory Panels' Recommendations On Antidepressants in Children FDA has released a statement saying it "generally supports" recent recommendations made by two of the agency's advisory committees regarding reports of increased risk of suicidal thoughts and actions in pediatric patients who use certain antidepressants. FDA is working to adopt new labeling that enhances warnings associated with antidepressant use and to strengthen information provided to patients who use these prescription drugs. http://www.fda.gov/bbs/topics/news/2004/NEW01116.html OTC Sale OK'd for Device to Restore Heart Rhythm After Cardiac Arrest FDA has granted marketing clearance for over-the-counter sales of the HeartStart Home Defibrillator, a device that shocks the heart to restore its rhythm following cardiac arrest. To get the OTC clearance, the manufacturer had to show that consumers could use the device safely without medical supervision. The device was available previously only by prescription. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01314.html FDA Approves Implanted Lens That Corrects Nearsightedness FDA has approved the Artisan, a plastic lens that can be implanted permanently in the eye to correct moderate-to-severe nearsightedness. The device offers consumers an alternative to glasses, contact lenses, and laser surgery such as LASIK. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01313.html ____________________________________________________________ Latest FDA Consumer Magazine Available Online The September-October 2004 issue of FDA Consumer has articles on the following topics: -- Cancer vaccines -- Researchers are studying experimental vaccines that can teach the body's own defenses to attack cancer cells. -- Psoriasis -- Though no cure exists for this physically and emotionally painful disease, new treatments are available. -- Medical leeches -- They've been used in medicine for thousands of years, but leeches only recently received FDA approval as medical devices. -- Buying Rx drugs online -- FDA has again warned consumers of risks associated with buying prescription drugs from unknown foreign sources. -- Breast implants -- Making informed decisions means knowing the risks as well as being aware of the benefits of breast implant surgery. -- Medical product development -- FDA is working with product developers to modernize development tools and to speed approval of new treatments. -- Unpasteurized milk -- FDA warns that drinking unpasteurized milk or eating products made from it is a dangerous practice. -- No vaccine/autism link -- Neither the measles-mumps-rubella (MMR) vaccine nor the vaccine preservative thimerosal is associated with autism, says a new report. Also included is an editorial on living with psoriasis. The issue is online at http://www.fda.gov/fdac/504_toc.html. Subscribe to FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html _____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reason shown. Go to the linked page for more information. California Natural Products beverages; various brand names and lot numbers (processing failure and potential contamination) http://www.fda.gov/oc/po/firmrecalls/cnp09_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 ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Acting Deputy Commissioner for Operations Janet Woodcock, M.D., before the House Subcommittee on Oversight and Investigations; subject: pediatric clinical trials for antidepressant drug products (Sept. 9) http://www.fda.gov/ola/2004/pediatric0909.html FDA Acting Director of the Office of Vaccines Research and Review William Egan, Ph.D., before the House Subcommittee on Human Rights and Wellness; subject: thimerosal in vaccines/autism (Sept. 8) http://www.fda.gov/ola/2004/vaccine0908.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be September 27. 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
