FDA News Digest November 15, 2004 __________________________________________________________ IN THIS WEEK'S ISSUE -- California Man Sentenced in Drug Counterfeiting Scheme -- FDA Offers Patient Information on Recently Approved Devices -- Latest FDA Consumer Magazine Available Online -- Recalls/Market Withdrawals -- Public Meetings __________________________________________________________ California Man Sentenced in Drug Counterfeiting Scheme A federal court has sentenced Christopher Wayne Lamoreaux to a 21-month prison term, probation, and monetary penalties for his role in a scheme to accept kickbacks for buying counterfeit and diverted prescription drugs and to repack these drugs for sale. The drugs -- the cholesterol-lowering medicine Lipitor and arthritis treatment Bextra -- were later distributed throughout the United States. FDA's Office of Criminal Investigations conducted the investigation. http://www.fda.gov/bbs/topics/news/2004/NEW01132.html FDA Offers Patient Information on Recently Approved Devices FDA's Center for Devices and Radiological Health has created consumer information Web pages for three recently approved medical devices. The pages, linked on the following list, briefly describe the devices, explain what they are intended to do, and how they should and should not be used. -- ExAblate 2000 System (removes uterine fibroids) http://www.fda.gov/cdrh/mda/docs/p040003.html -- EVS Vascular Closure System (to stop bleeding following heart catheterization) http://www.fda.gov/cdrh/mda/docs/p040022.html -- HeartStart Home OTC Defibrillator (to restore normal heart rhythm following cardiac arrest) http://www.fda.gov/cdrh/mda/docs/k040904.html __________________________________________________________ Latest FDA Consumer Magazine Available Online The November-December 2004 issue of FDA Consumer has articles on the following topics: -- Vioxx -- This arthritis drug was withdrawn following concerns about heightened health risks. -- Flu -- Vaccine recommendations for this flu season. -- Attention Deficit Hyperactivity Disorder and Adults -- Several approved drugs can treat ADHD symptoms in adults. -- Infertility -- Some answers to questions for those struggling to conceive. -- Deep Vein Thrombosis -- Some expert advice to help prevent blood clots in the legs. -- Public Comment to FDA -- Consumers and others can comment on proposed regulations. -- Project Bioshield -- This new law improves public health defenses against biological, radiological, and nuclear attack. Also included is an editorial on living with attention deficit hyperactivity disorder. The issue is online at http://www.fda.gov/fdac/604_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 reasons shown. Go to the linked page for more information. Kingsway Trading Expellin Extract and Cardio Flex Dietary Herbal Supplements (contains aristolochic acid) http://www.fda.gov/oc/po/firmrecalls/kingsway11_04.html Access Cardiosystems Inc. Automated External Defibrillators (problems with shock delivery and potential to turn on unexpectedly) http://www.fda.gov/oc/po/firmrecalls/accessCardio11_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 _________________________________________________________ PUBLIC MEETINGS Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002; Gaithersburg, Md. http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm Dec. 2 -- Advisory Committee for Reproductive Health Drugs; under discussion: pending application for a testosterone patch to help improve sexual desire in surgically menopausal women (Gaithersburg, Md.) http://www.fda.gov/oc/advisory/accalendar/2004/cder12537d120204.html 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 November 22. 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
