FDA News Digest March 17, 2003 ________________________________________________________________ FDA Proposes Bar Codes for Drugs, Blood; New Adverse Reaction Reporting FDA has proposed two rules to help improve patient safety by reducing medication errors and by more quickly identifying potential errors. One proposal would require bar codes containing unique identifying information as part of the labeling on prescription drugs, over-the-counter drugs packaged for hospital use, vaccines, blood, and blood products. The other proposal would strengthen FDA's current safety reporting for drugs and biological products to identify problems both during clinical trials and after the products are on the market. http://www.fda.gov/oc/initiatives/barcode-sadr/default.htm ________________________________________________________________ Drug for Advanced HIV Is First in New Class of Treatments FDA has approved Fuzeon (enfuvirtide), a new type of injected HIV drug for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children 6 years and older. The drug augments current HIV treatments by affecting the spread of the virus in a different way from other medications. FDA approved the drug under an accelerated approval, which helps speed new drugs to market for people with serious or life-threatening illnesses. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00879.html ________________________________________________________________ FDA Approves Lower Dose of Postmenopausal Drug Prempro FDA has approved a lower dose of Prempro, an estrogen and progestin combination drug that treats symptoms such as hot flashes, night sweats and vaginal dryness in postmenopausal women. Though the new drug now gives women an additional treatment option, FDA urges women considering such treatments to discuss with their doctors whether the benefits of the drug outweigh the risks for them individually. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00878.html _________________________________________________________________ FDA Warns Public About Misrepresented Claims for Cancer Drug FDA is warning that a press release distributed by SuperGen Inc., makes false claims about the company's cancer drug Mitozytrex. Among discrepancies noted by FDA: exaggeration of the drug's effectiveness and a failure to note risks of taking the drug, including its possible adverse effects. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01204.html _________________________________________________________________ FDA Warns About Counterfeit Anemia Drug Procrit FDA has uncovered three lots -- a total of 120,000 units -- of contaminated counterfeit Procrit (epoetin alfa), a drug used to stimulate production of red blood cells in humans to treat severe anemia. FDA has issued a statement urging health care providers and patients to check packaging and vials carefully before using the product and giving instructions on what to do if they find counterfeit Procrit. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00877.html _________________________________________________________________ Latest FDA Consumer Magazine Available Online The March-April issue of FDA Consumer, available online at http://www.fda.gov/fdac/203_toc.html has articles on the following topics: . * FDA's new commissioner -- Mark B. McClellan, M.D., shares his vision of the challenges and opportunities that lie ahead for the agency. * Consumer drug advertising -- FDA surveys show that direct-to-consumer ads can be beneficial to both doctors and their patients. * Asthma -- Keeping this disorder under control. * Smallpox -- Questions and answers about the disease and its vaccine. * Estrogen/progestin drugs -- FDA action helps clear up confusion about these products for postmenopausal women. * Prescription drug abuse -- FDA teams with the Substance Abuse and Mental Health Services Administration to launch a new public education program. * FDA science -- Agency scientists apply new technologies and methods to protect public health. * Medical device user fees -- New law aims to reduce time to market for devices without compromising safety and effectiveness. The issue also has: * a commentary on asthma management in schools * a report on a wholesaler who received a 44-month prison term for selling counterfeit baby formula * the "fda.gov" column, which reviews and previews health-related websites. _________________________________________________________________ PUBLIC MEETINGS April Workshop to Discuss Risk Management for Drugs, Biologics FDA will sponsor a public workshop April 9-11 in Washington, D.C., to present the agency's current thoughts on risk management for drug and biologic products (excluding blood products other than plasma derivatives) and to solicit public opinions on the subject. http://www.fda.gov/cder/meeting/riskManagement.htm For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. _________________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be March 24. 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