FDA News Digest November 4, 2002 _______________________________________________________________ Approval of Generic Version of Prilosec Called a 'Win-Win' FDA has approved a generic version of omeprazole, allowing the first marketing of a product that can compete with the brand-name drug Prilosec to treat certain gastrointestinal conditions. Health and Human Services Secretary Tommy G. Thompson called the approval "a win-win for patients" and added that "for those who could not afford the brand-name drug, [the approval] means greater access to a successful medication at a lower cost." http://www.fda.gov/bbs/topics/NEWS/2002/NEW00848.html _______________________________________________________________ FDA Issues Alert for Mexican Cantaloupes Due to Salmonella Outbreaks Because of unsanitary conditions that have resulted in four U.S. outbreaks of foodborne illness due to Salmonella bacteria in the last three years, FDA has issued an alert for cantaloupes from Mexico to be detained at all U.S. ports. The outbreaks are responsible for two deaths and at least 18 hospitalizations. Release: http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01167.html Spanish version: http://www.fda.gov/bbs/topics/ANSWERS/SPANISH/span01167.html _______________________________________________________________ Infant Formula Recalled After Bacterial Contamination Found Wyeth Nutritionals Inc. is recalling various batches of its powdered infant formula manufactured between July 12 and Sept. 25, 2002, after FDA tests detected the presence of Enterobacter sakazakii, a bacterium that can, in rare cases, cause complications in infants such as meningitis (brain inflammation) and sepsis (bacteria in the blood). About 1.5 million cans of milk- and soy-based formula, sold under several brand names, are being recalled. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00849.html _______________________________________________________________ FDA Warns Public About Possible Complications of Bone Cement FDA has notified the public that a bone cement used to treat spinal fractures related to the bone-thinning disorder osteoporosis has been linked to tissue damage, nerve pain, respiratory and cardiac failure, and even death. The agency is working with manufacturers of orthopedic devices to evaluate the long-term safety and effectiveness of the cement used in these spinal procedures. http://www.fda.gov/cdrh/safety/bonecement.html _______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be November 12. 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
