FDA News Digest September 16, 2002 ______________________________________________________________ Five Kidney Dialysis Deaths Possibly Linked to Blood Tubing Baxter Healthcare Corporation has notified dialysis centers that certain blood tubing used with its Meridian dialysis machines may be linked to five patient deaths and two injuries. Though the cause of the deaths hasn't been determined, the company has asked dialysis centers to discontinue using certain models of tubing and use other available models instead. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00835.html ______________________________________________________________ Draft Guidance Issued to Evaluate Safety of New Antimicrobial Animal Drugs Prompted by concerns that use of antimicrobial drugs in food-producing animals may lead to emergence of drug-resistant pathogens, FDA has drafted a guidance document that recommends an approach for assessing the safety of new antimicrobial animal drugs. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01162.html ______________________________________________________________ Health Advisory Issued About Increased Listeria Cases in Pennsylvania FDA and the U.S. Department of Agriculture's Food Safety Inspection Service are warning about a recent rise in Listeria monocytogenes cases in Pennsylvania. Listeria bacteria can cause serious and possibly fatal infections in newborns, the elderly, and those with weakened immune systems. The two agencies have not pinpointed a specific contaminated food but are recommending that at-risk individuals avoid certain foods. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00836.html ______________________________________________________________ FDA's Plans for Implementing Bioterrorism Law Explained on New Website Signed into law last June, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires numerous actions by FDA. A new website contains the text of the law and FDA's plans for implementing sections relevant to the agency. http://www.fda.gov/oc/bioterrorism/bioact.html ______________________________________________________________ Website Offers Information on Analgesics and Anti-Inflammatory Drugs FDA's Center for Drug Evaluation and Research has created a website that explains how analgesic (pain relief) and anti-inflammatory drugs are approved and provides information on approved products in those categories. Also on the site is a list of Web resources for arthritis information. http://www.fda.gov/cder/drug/Analgesia_antiinflam/default.htm _______________________________________________________________ Blood Pressure, Male Osteoporosis Among Topics in Latest FDA Consumer The September-October 2002 issue of FDA Consumer magazine, available at http://www.fda.gov/fdac/502_toc.html, has articles on the following topics: * Blood pressure monitors -- Replacing standard mercury-filled devices with environmentally friendly ones won't be simple. * Vaccine shortages -- Serious shortages of several vaccines appear to be over. * Osteoporosis and men -- This bone-thinning condition affects mainly women, but men should be concerned, too. * Imported drugs -- Unapproved drugs that come into the United States from foreign countries carry potential health risks. * Generic drugs -- These products make up about half of all prescriptions in this country. * Food freshness -- "Smart" packaging can now indicate food spoilage. * Treating "minor" animal species -- A shortage of approved drugs to treat wildlife, exotic animals, and some pets may be eased through research partnerships and proposed legislation. The issue also has: * a commentary on how FDA uses sound scientific methods to further its goals, * a report on a couple that received significant prison sentences for running a "virtual pharmacy" that illegally sold prescription drugs, * the "fda.gov" column, which reviews and previews health-related websites. _________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be September 23. 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
