FDA News Digest March 31, 2003 ________________________________________________________________
FDA Clears Skin Lotion to Protect Military Against Chemical Warfare Burns FDA has cleared for use Reactive Skin Decontamination Lotion, which is applied to the skin to remove or neutralize chemical warfare agents and T-2 fungal toxin. The lotion, supplied as a sponge pad in a sealed pouch, must be applied as soon as possible after exposure to the chemical agent. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00888.html ________________________________________________________________ Drug Combats Nausea, Vomiting in Patients Receiving Chemotherapy FDA has approved Emend (aprepitant) to be used with other drugs to help prevent nausea and vomiting associated with chemotherapy. The drug is the first to prevent the delayed nausea and vomiting that many patients experience more than 24 hours after receiving chemotherapy. FDA Commissioner Mark B. McClellan, M.D., says the new drug "should improve cancer patients' quality of life." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00886.html ________________________________________________________________ New Warnings Added to Labels of Scabies, Lice Treatment Lindane Because of the potential for harm to nerves and the brain in patients under 110 pounds who use Lindane products to treat scabies or lice, FDA has announced labeling changes for the drug that include new warnings and the addition of a medication guide for distribution directly to patients. Lindane should be used only when other treatments are not tolerated or other approved therapies fail. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01205.html ________________________________________________________________ New Type of Drug Approved to Treat Growth Hormone Disorder FDA has approved Somavert (pegvisomant) to treat acromegaly, a potentially life-threatening disease triggered by an excess of growth hormone. The drug, the first in a new class called growth hormone receptor antagonists, is intended for patients who have had an inadequate response to existing therapies. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00885.html ________________________________________________________________ FDA Supports Okla. Action Against Pharmacy Obtaining Canadian Drugs FDA is supporting Oklahoma's petition for an injunction seeking to stop Rx Depot from violating state law by obtaining unapproved drugs from Canada for customers in the United States. FDA says the company is exposing the public to significant potential risks associated with unregulated imported prescription medicines. FDA is concerned that the company has made misleading assurances about the safety of the drugs. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00887.html ________________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: Ben & Jerry's Karamel Sutra Ice Cream (undeclared peanuts) -- http://www.fda.gov/oc/po/firmrecalls/ben&jerry03_03.html Sara Lee Butter Streusel Coffee Cake (some packages may contain another type of cake topped with pecans, a potential hazard to pecan-sensitive individuals) -- http://www.fda.gov/oc/po/firmrecalls/saralee03_03.html Maribel Sweets Aztec Hot Chocolate, 10- and 20-oz. packages (undeclared milk) -- http://www.fda.gov/oc/po/firmrecalls/maribel03_03.html Master Chao Brand Glace Coconut (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/hotrading03_03.html Gusto Brand Thai Preserved Pineapple (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/gusto03_03.html Siamese Coins Sour Bamboo Shoot Tip (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/siamesecoin_state03_03.html Nicer Succade Dried Potatoes (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/monchongloong03_03.html Kien Import Corp. Dried Plums (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/kien03_03.html Sincere Trading Co. Dried Plums (undeclared sulfites) -- http://www.fda.gov/oc/po/firmrecalls/sincere03_03.html ________________________________________________________________ PUBLIC MEETINGS FDA Science Forum to Discuss Risk Assessment, Cancer, Public Health The 9th Annual FDA Science Forum will be held in Washington, D.C., April 24-25. Open to the public, the forum brings FDA scientists together with industry, academia, consumers, and others to share information about the science-based mission of the agency. Discussion topics for this year's forum include risk assessment, cancer treatments, and public health initiatives in the wake of 9/11/01. http://www.dcscienceforum.org April Workshop to Discuss Risk Management for Drugs, Biologics FDA will sponsor a public workshop April 9-11 in Washington, D.C., to present the agency's current thoughts on risk management for drug and biologic products (excluding blood products other than plasma derivatives) and to solicit public opinions on the subject. http://www.fda.gov/cder/meeting/riskManagement.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. ________________________________________________________________ How's your knowledge of health-related topics such as menopause, smallpox, and asthma? Find out by taking our 9-question quiz at http://www.fda.gov/fdac/quiz/onlinequiz10_js.html. ________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be April 7. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
