FDA NEWS DIGEST -- JULY 22, 2002 NEW DRUG APPROVED TO TREAT CATAPLEXY ATTACKS IN NARCOLEPSY PATIENTS -- FDA has approved Xyrem, a form of GHB, to treat narcolepsy patients who experience attacks of cataplexy (weak or paralyzed muscles). Narcolepsy, a condition that causes an irresistible tendency to fall asleep, affects about 120,000 people in the United States. Because of safety concerns, the drug, which has a history of illegal abuse, will be tightly controlled. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01157.html APPROVAL WIDENED FOR IMPLANTABLE DEFIBRILLATORS -- FDA has approved a new indication for Guidant Corporation's implantable cardioverter defibrillators (ICDs) to include patients with a history of heart attack and depressed heart function. The devices previously were approved for patients who had survived cardiac arrests and for those who had undergone invasive electrical testing to determine if they were suitable candidates for an ICD. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01159.html UNSAFE MEDICAL DEVICES DESTROYED -- About $200,000 worth of medical devices manufactured by A & A Medical Inc./Rocket USA/LifeQuest Medical Inc., of Alpharetta, Ga., were destroyed on July 11 as a result of regulatory action by FDA. The devices, which included uterine dilators and fetal blood samplers, were determined to be unsafe because of inadequate sterilization. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00823.html FDA SPECIAL AGENT CITED FOR FRAUD PREVENTION -- Tom Harkness, a special agent in FDA's Office of Criminal Investigations, has received the Attorney General's Award for Fraud Prevention for his work in uncovering the marketing misconduct and fraudulent drug pricing schemes of TAP Pharmaceutical Products, Inc. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01158.html ________________________________________________________ HOW'S YOUR KNOWLEDGE about health-related topics such as eye diseases, Botox, antibiotic resistance, and sunglasses? Find out by taking our 10-question online quiz at: http://www.fda.gov/fdac/quiz/onlinequiz6_js.html ________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be July 29. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
