FDA News Digest August 2, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Newly Approved Drug Treats Alcoholics Who Have Stopped Drinking -- FDA Warns Consumers About Counterfeit Drugs Bought in Mexico -- Castor Beans, Not Purified Ricin, Found in Baby Food in Calif. Tampering -- Recalls/Market Withdrawals -- Public Meetings -- Congressional Testimony ______________________________________________________________ Newly Approved Drug Treats Alcoholics Who Have Stopped Drinking FDA has approved Campral (acamprosate) to treat alcoholics seeking to stay alcohol-free after they have stopped drinking. The drug may not be effective in those who are still drinking when treatment begins or who abuse other substances in addition to alcohol. Campral is the first new drug approved for alcohol abuse in a decade. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01302.html FDA Warns Consumers About Counterfeit Drugs Bought in Mexico FDA is warning that two prescription drugs reportedly bought recently in a Mexican border town and imported into the United States are counterfeit versions of the cholesterol-lowering drug Zocor (simvastatin) and the pain drug carisoprodol. The incident reinforces FDA's concerns about the questionable quality, safety and efficacy of drugs bought outside the United States. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01303.html Castor Beans, Not Purified Ricin, Found in Baby Food in Calif. Tampering An FDA analysis has pinpointed ground castor beans as the source of contamination found in two jars of baby food in Irvine, Calif. Contrary to early reports, the agency says, the jars did not contain purified ricin, a much more toxic substance that is derived from castor beans. An apparent case of product tampering, the tainted food seems confined to the Irvine area. http://www.fda.gov/bbs/topics/news/2004/NEW01097.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Cablanca brand goat cheese (undeclared egg component) http://www.fda.gov/oc/po/firmrecalls/jana07_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 Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Associate Commissioner for Regulatory Affairs John M. Taylor III, before the Permanent Subcommittee on Investigations, Committee on Governmental Affairs (July 22) http://www.fda.gov/ola/2004/importeddrugs0722.html To view an archive of Congressional testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be August 9. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-
