FDA News Digest December 2, 2002 _____________________________________________________________ Allergy Drug Claritin Approved for Over-the-Counter Sales FDA has approved the drug Claritin (loratadine) as an over-the-counter (OTC) treatment for seasonal allergy symptoms such as nasal congestion, sneezing, and itchy nose, throat, eyes, and ears. Previously available only by prescription, Claritin met FDA's criteria for OTC marketing when the agency determined, among other things, that the drug could be used safely by consumers without medical supervision. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00855.html _____________________________________________________________ Non-Stimulant Approved for Treating Hyperactivity Disorder FDA has approved Strattera (atomoxetine), the first new drug in three decades for treating attention deficit hyperactivity disorder (ADHD). Strattera has a different mechanism of action from the stimulant-like drugs previously used to treat ADHD, thus the drug does not appear to have potential for abuse. In clinical trials, the drug was studied in children, adolescents, and adults, and it was shown to improve symptoms significantly when compared to a placebo. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01177.html _____________________________________________________________ Osteoporosis Drug is First That Stimulates New Bone Formation FDA has approved Forteo (teriparatide), the first drug for stimulating new bone formation. The drug is intended for use in postmenopausal women and in men with primary or hypogonadal osteoporosis at high risk of having a fracture. About 10 million Americans--80 percent of them women--have osteoporosis, a progressive thinning of bones that increases the risk of spine, wrist and hip fractures. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01176.html _____________________________________________________________ Nonsurgical Device Treats Uterine Fibroids by Shrinkage FDA has cleared for marketing a nonsurgical device that treats uterine fibroids (benign uterine tumors) by shrinking them. The procedure could save many women from having myomectomies (fibroid removal that leaves the uterus intact) or hysterectomies (removal of the uterus). http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01175.html _____________________________________________________________ FDA Commissioner Speaks About Agency Priorities At a conference in Houston last week, FDA Commissioner Mark B. McClellan, M.D., explained that his agenda for the agency includes four priorities: to ensure a strong, science-based FDA; to protect the public's health against a potential terrorist attack; to help consumers get reliable information about FDA-regulated products; and to reduce preventable adverse health events from FDA-regulated products. http://www.fda.gov/oc/speeches/2002/healthservice.html ______________________________________________________________ Website Explains Ethics Rules That Govern FDA Employees FDA has launched a new website containing information for agency employees and the public about FDA's ethics program, which is designed to help ensure that decisions made by agency employees are not tainted by any question or appearance of conflict of interest. The site provides guidance about issues such as gifts and awards, financial interests, outside employment, and political activities. http://www.fda.gov/opacom/ethics/ _____________________________________________________________ New Website Compiles FDA's Spanish Publications Dozens of FDA's Spanish-language publications are within easy reach on a new website that includes materials related to all products the agency regulates. Many of the publications are written for consumers; others provide guidance for FDA-regulated companies. Subjects found on the site include rare diseases, using medicine wisely, eating for a healthy heart, mammograms, and foodborne illness. The site also links to general information about health conditions such as diabetes, the flu, and hearing loss. http://www.fda.gov/oc/spanish/ _____________________________________________________________ HHS-Sponsored Site Offers Information about AIDS Treatments and Research A federally sponsored website offering comprehensive information on HIV/AIDS treatments and clinical trials was launched today to mark World AIDS Day. The site, AIDSinfo, provides a single, searchable resource of HIV/AIDS treatment guidelines and information about all federally funded and privately sponsored HIV/AIDS clinical trials. The site also includes information about FDA-approved therapies. AIDSinfo is sponsored by several agencies within the U.S. Department of Health and Human Services. http://aidsinfo.nih.gov ____________________________________________________________ How's your knowledge about health-related topics such as medicine use, oxygen bars, skin cancer, and sleep disorders? Find out by taking our 10-question quiz at http://www.fda.gov/fdac/quiz/onlinequiz8_js.html. ____________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be December 9. 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
