FDA News Digest November 18, 2002 _____________________________________________________________ Reported Adverse Reactions Prompt New Warnings for Pain Drug Bextra FDA and pharmaceutical manufacturer Pharmacia are advising health care professionals about reported serious, but rare, adverse effects linked to the arthritis and menstrual pain treatment Bextra (valdecoxib) that include potentially life-threatening skin reactions. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01170.html _____________________________________________________________ Sterility Questioned in Injectable Drugs Made by S. Carolina Pharmacy FDA has issued a warning to consumers and health care professionals that use of all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, S.C., should be discontinued because FDA lacks assurance that the drugs are sterile. FDA believes the company's products have been distributed in 11 states. One of Urgent Care's drugs was recalled in September after four patients who used it developed a rare fungal meningitis. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01171.html _____________________________________________________________ FDA Commissioner Cites 'Better Future' of FDA at Groundbreaking Speaking at the Nov. 15 groundbreaking for a new FDA facility in White Oak, Md., FDA Commissioner Mark B. McClellan, M.D., told attendees, "Standing here today, I don't see just a nice tent and a construction site. I see a better future of the FDA." The groundbreaking represents an early phase of a massive project that ultimately will consolidate much of FDA's operations at the White Oak site. http://www.fda.gov/oc/speeches/2002/whiteoak1.html ______________________________________________________________ Deputy Commissioner Speaks About FDA's User Fee Experiences At the Financial Times of London's Global Pharmaceutical Conference earlier this month, FDA Deputy Commissioner Dr. Lester M. Crawford discussed FDA's experiences with charging user fees to drug companies seeking approval of their products. http://www.fda.gov/oc/speeches/2002/london.html ______________________________________________________________ FDA's 2003 Science Forum Now Open for Registration Interested persons can register now for the 9th Annual FDA Science Forum, to be held April 24-25, 2003, in Washington, D.C. Open to the public, the forum brings scientists from all disciplines and organizational components of FDA together with industry, academia, consumers, and others to share information about the science-based mission of the agency. Discussion topics include risk management and public health initiatives in the wake of 9/11/01. http://www.dcscienceforum.org ______________________________________________________________ Latest FDA Consumer Available Now Online The November-December issue of FDA Consumer magazine, available at http://www.fda.gov/fdac/602_toc.html, has articles on the following topics: * Sleep deprivation -- Not getting enough shuteye can have serious consequences. This article offers tips for solving sleep problems. * Oxygen bars -- Dispensing oxygen without a prescription is against federal law, and oxygen bars may subject customers to unnecessary risk. * Benefits/risks of medicines -- This article gives advice on how to make wise decisions about the drugs you take. * Sunning for science -- FDA is examining what happens to the skin when chemicals in some moisturizing and beauty products are exposed to sunlight. * Plastics and the microwave oven-- From plastic wrap to popcorn bags, FDA reviews substances used to make plastics for food use. * The "Poison Squad" -- A hundred years ago, government volunteers dined on carefully prepared foods laced with potentially poisonous preservatives, all in the interest of science. * FDA's public affairs specialists -- This year marks the 50th anniversary of this elite corps of FDA professionals who deliver health information to consumers. The issue also has: * food safety tips to help ensure that your holidays stay happy, * a report on some dairy operators who received fines for "milking" customers, * and the "fda.gov" column, which reviews and previews health-related websites. _________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be November 25. 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
