FDA News Digest July 6, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Counterfeit Viagra Found in Two California Pharmacies -- FDA Warns About Adverse Effects From 'Permanent Makeup' Ink -- FDA Clears Leeches for Use as Medical Devices -- FDA Supports Broader Access to Lower-Priced Drugs -- Federal Officials Seize Faulty Patient Lifts with Dangerous Defect -- Recalls/Market Withdrawals -- Recent Speeches -- Congressional Testimony -- Public Meetings ______________________________________________________________ Counterfeit Viagra Found in Two California Pharmacies FDA is alerting pharmacies and the public that counterfeit versions of the erectile dysfunction drug Viagra have been found in two California pharmacies. FDA and Viagra manufacturer Pfizer Inc. have released information on how to identify the fake Viagra packaging and tablets. FDA's Office of Criminal Investigations is investigating the case. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01083.html To identify fake Viagra: www.pfizer.com/subsites/counterfeit_importation/mn_pharmacist_viagra.html FDA Warns About Adverse Reactions From 'Permanent Makeup' Ink FDA is warning the public that the agency has received more than 50 reports of adverse reactions among people who have undergone a type of tattooing that applies a "permanent makeup" for lip liner, eyeliner, or eyebrow color. Reported skin reactions include swelling, cracking, peeling, blistering, and scarring. There have also been cases of chronic inflammation associated with infection. In some cases, the reactions caused serious disfigurement, resulting in difficulty eating and talking. FDA has released a list of tattoo ink shades, manufactured by Premier Products, associated with the reported adverse reactions. Press release: http://www.fda.gov/bbs/topics/answers/2004/ANS01295.html Ink shades associated with adverse reactions: http://www.cfsan.fda.gov/~dms/cos-tat2.html General information on tattoos: http://www.fda.gov/oc/opacom/hottopics/tattoos.html FDA Clears Leeches for Use as Medical Devices FDA has cleared the marketing of leeches as medical devices for uses such as removing pooled blood under skin grafts. Leeches are bloodsucking aquatic animals that live in fresh water. They have been used for various types of medical treatments for several thousand years, reaching their height of use in the mid-1800s. The marketing clearance, granted to French firm Ricarimpex SAS, is the first of its kind. http://www.fda.gov/bbs/topics/answers/2004/ANS01294.html FDA Supports Broader Access to Lower-Priced Drugs With its denial of recent petitions submitted by three pharmaceutical companies, FDA has promoted quicker access to lower-priced prescription drugs. The petitions requested revisions to longstanding agency policies regarding the marketing of authorized generic drugs and the 180-day "exclusivity" provision for new generic drugs. But FDA denied all three petitions in a move to keep competitive business practices in place, which the agency says will help make generic drugs available sooner at a lower cost. http://www.fda.gov/bbs/topics/answers/2004/ANS01296.html Federal Officials Seize Faulty Patient Lifts with Dangerous Defect U.S. authorities have filed suit to seize 26 Faaborg Patient Lifts from Illinois-based Moving Solutions, Inc., because they can break and seriously harm patients. The lifts are mechanical sling-like devices used to lift and move patients. According to the lawsuit and FDA reports, one patient died and one was seriously injured because of the faulty devices. http://www.fda.gov/bbs/topics/news/2004/doj0628.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. Blooming Import Inc. "Dried Potatoe"; 12-oz. plastic bags (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/blooming06_04.html Various U.S. Trading Co. "999 Three Nine Brand" products (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/ustrading06_04.html M&P Fine Foods (Bento & Co.) "Asian Noodle Bowl Vegetarian Yakisoba" and "Asian Noodle Bowl Yakisoba w/Vegetables" (undeclared soybeans, wheat, yellow #5, yellow #6) http://www.fda.gov/oc/po/firmrecalls/mp06_04.html John B. Sanfilippo and Son Inc.'s "Evon Brand California Mix" (11 oz.) and unbranded California Mix (1 lb. 5 oz.) (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/sanfilippo06_04.html Royal Seafood International Inc. (Net Cost Market) "Uniservis Majonez Luksusowy" (mayonnaise); 600-gram jar (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/royalsea06_04.html Meadow Valley Farm sharp cheddar cheese (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/meadowvalley07_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 ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the annual convention of the American Seed Trade Association and the American Organization of Seed-Certifying Agencies (June 29) http://www.fda.gov/oc/speeches/2004/asta0629.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Acting Commissioner Lester M. Crawford, D.V.M., before the House Committee on Energy and Commerce, Subcommittee on Health; subject: implementation of the food security provisions of the Public Health Security and Bioterrorism Preparedness and Response Act (June 25) http://www.fda.gov/ola/2004/bioterrorism0625.html FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Senate Committee on the Judiciary; subject: "The Law of Biologic Medicine" (June 23) http://www.fda.gov/ola/2004/fob0623.html To view an archive of Congressional testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ PUBLIC MEETINGS July 20-23 - National Health Information Infrastructure 2004: Cornerstones for Electronic Healthcare; Washington, D.C. http://www.hsrnet.net/nhii/welcome.htm For a list of upcoming 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 July 12. 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
