FDA News Digest for February 4, 2008

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FDA News Digest February 4, 2008 ___ IN THIS WEEK'S ISSUE » News -- Food, Medical Product Safety Among Key FY 'O9 FDA Budget Requests -- Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use -- FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries » Safety Alerts/Recalls » Upcoming Public Meetings » Consumer Health Information ________ NEWS Food, Medical Product Safety Among Key FY 'O9 FDA Budget Requests FDA is requesting nearly $2.4 billion as part of the president's fiscal year (FY) 2009 budget—a 5.7 percent increase over the current fiscal year budget. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use FDA has alerted health care professionals about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent). http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to a narrowed section of a coronary artery through a long, thin catheter. When the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01787.html To view an archive of recent FDA news releases, go to http://www.fda.gov/opacom/hpnews.html. To access the RSS feed of FDA news releases, go to http://www.fda.gov/bbs/topics/news/rssPress.xml. [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.] ___________ CONGRESSIONAL TESTIMONY Jan. 29 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations. "Science at FDA" http://www.fda.gov/ola/2008/science012908.html To view an archive of past testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ___________ SAFETY ALERTS/RECALLS For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the past 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 [What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.] ________________ UPCOMING PUBLIC MEETINGS Feb. 5 -- Cellular, Tissue and Gene Therapies Advisory Committee Under discussion: updates of ongoing research programs Location: Bethesda, Md., and by teleconference http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-25124.htm Feb. 6 -- Psychopharmacologic Drugs Advisory Committee Under discussion: pending application for a new schizophrenia treatment Location: Silver Spring, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24627.htm For a complete list of FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. CONSUMER HEALTH INFORMATION Each week in FDA News Digest, we spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates. Here's what's in the spotlight this week: › Devices That Keep the Heart Beating http://www.fda.gov/consumer/features/cardiacdevices013008.html › Pet Turtles: Cute but Contaminated with Salmonella http://www.fda.gov/consumer/updates/turtles012508.html If you would like to sign up to receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist.