FDA NEWS DIGEST -- JUNE 10, 2002 FDA APPROVES RESTRICTED MARKETING OF LOTRONEX -- FDA has approved the marketing of Lotronex to treat women with severe, diarrhea-predominant irritable bowel syndrome but with restrictions and provisions that include a risk management plan. Lotronex was voluntarily withdrawn from the market in November 2000 following reports of serious and life-threatening adverse events. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00814.html FDA STEPS UP POST-MARKETING SURVEILLANCE OF MEDICAL DEVICES -- To reduce the number of adverse events from medical device failure, manufacturers of certain critical devices will be required to gather data on their products' performance for up to three years. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00813.html LABELING CHANGED FOR ARTHRITIS TREATMENT CELEBREX -- Based on results of a recent study, FDA has approved new labeling for arthritis drug Celebrex to show that there is no safety advantage in upper gastrointestinal events for the drug when compared with two other treatments, ibuprofen and diclofenac. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01151.html _________________________________________________________________ Thanks for subscribing to the FDA News Digest. The next posting will be sent June 17. 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"
