FDA News Digest October 18, 2004 __________________________________________________________ IN THIS WEEK'S ISSUE -- Safeguards Strengthened for Using Antidepressants in Children -- FDA Inspection Finds No Chiron Flu Vaccine Safe for U.S. -- Temporary Artificial Heart Approved for Patients Awaiting Transplants -- FDA Reports Progress on Agency Strategic Action Plan -- Recalls/Market Withdrawals -- Recent Speeches -- Public Meetings _________________________________________________________ Safeguards Strengthened for Using Antidepressants in Children FDA is taking steps to ensure that the public understands the potential risks of suicidal thoughts and behavior in children and adolescents who take antidepressant drugs. The agency is directing manufacturers to add a "black box" warning to the labeling of all antidepressant drugs and is developing a patient medication guide that explains the risks and appropriate precautions. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01124.html Public health advisory: http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm Antidepressant information: http://www.fda.gov/cder/drug/antidepressants/default.htm FDA Inspection Finds No Chiron Flu Vaccine Safe for U.S. Following an inspection of the Chiron Corp.'s Liverpool, England, production facility for the flu vaccine Fluvirin, FDA officials have determined that none of the vaccine is safe for use in the United States. Chiron's vaccine was to make up about half of this flu season's supply for the United States. After finding some lots of Fluvirin to be contaminated, British regulators on Oct. 5 suspended Chiron's license to produce the vaccine, eliminating it as a vaccine source. FDA is working with British officials to identify significant issues before production of the 2005 flu vaccine begins. http://www.fda.gov/bbs/topics/news/2004/NEW01125.html Temporary Artificial Heart Approved for Patients Awaiting Transplants FDA has approved an artificial heart designed to keep patients alive while they await a heart transplant. The device, which temporarily replaces the left and right ventricles (bottom part of the heart), is intended for heart-transplant candidates who do not respond to other treatments and who are at imminent risk of death. In clinical studies, 79 percent of those implanted with the device stayed alive long enough to receive a donor heart. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01317.html FDA Reports Progress on Agency Strategic Action Plan In 2003, FDA issued a plan that set action goals for the agency and mapped out a strategy to achieve them. To chart progress made toward the goals in the past year, the agency has released a report called "Progress and Priorities 2004." Agency achievements covered in the report include: enhanced consumer protection through new bioterrorism countermeasures, improved protections against medical errors, and increased efficiency of FDA reviews of new regulated products. http://www.fda.gov/oc/initiatives/reports/priorities2004.html _________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Great Value white bread; three sizes and types (undeclared whey) http://www.fda.gov/oc/po/firmrecalls/interstate10_04.html Zambales Bakery Atchara (pickled papaya) and Ampalaya Atchara (possible Clostridium botulinum contamination) http://www.fda.gov/oc/po/firmrecalls/zambales10_04.html Golden Lion Brand Dried Ziziphus Jujuba Mill (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/blooming10_04.html Lotte Brand Custard Pie (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/haemalkn10_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 _________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Soyfoods Association of America Conference on Creating a Healthier America (Oct. 14) http://www.fda.gov/speeches/speechli.htm _________________________________________________________ PUBLIC MEETINGS Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm For a list of 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 October 25. 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
