FDA News Digest March 1, 2004 ______________________________________________________________
THIS WEEK'S NEWS -- FDA Rule Requires Bar Codes on Drugs, Blood to Help Prevent Errors -- New Type of Treatment Approved for Advanced Colon Cancer -- HHS Task Force to Study Importing Prescription Medicines -- New Federal Programs to Address Prescription Drug Abuse -- U.S. Signs Charter With Mexico, Canada on Public Health Issues -- Pump Approved for Children Waiting to Receive a Heart Transplant -- New Web Site Focuses on Prevention, Diagnosis, Treatment of Heart Disease -- FDA Warns Consumers to Avoid Herbal 'Green Hornet' Product -- Recalls, Market Withdrawals -- Meetings ______________________________________________________________ FDA Rule Requires Bar Codes on Drugs, Blood to Help Prevent Errors As part of a wide-ranging effort to improve patient safety, FDA has finalized a rule requiring bar codes -- similar to those found on foods and other consumer products -- on thousands of human drugs and biological products. The measure aims to protect patients from medication errors by helping ensure that health professionals give the right drugs at the right dosages to the right patients. The rule also requires machine-readable information on container labels of blood and blood components intended for transfusion. Press release: http://www.fda.gov/bbs/topics/news/2004/hhs_022504.html Additional information: http://www.fda.gov/oc/initiatives/barcode-sadr/ New Type of Treatment Approved for Advanced Colon Cancer FDA has approved Avastin (bevacizumab) for treating colon cancer that has spread to other parts of the body. Avastin is the first drug to be approved that works by preventing the formation of new blood vessels, shutting off blood, oxygen and other nutrients tumors need to grow. The drug was shown to extend patients' lives about five months when used with standard chemotherapy drugs. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01027.html HHS Task Force to Study Importing Prescription Medicines The Department of Health and Human Services has created a multi-agency task force to study how drug importation may be conducted safely and what impact it might have on patient health, medical costs, and development of new medicines. Press release: http://www.fda.gov/bbs/topics/news/2004/hhs_022604.html Fact sheet: http://www.fda.gov/bbs/topics/news/2004/hhs_fs022504.html New Federal Programs to Address Prescription Drug Abuse FDA has joined with several other agencies to release the White House National Drug Control Strategy, which outlines measures aimed at curbing the non-medical use of prescription drugs. Included in the strategy are programs to prevent the misuse of pain management drugs, educate medical professionals and consumers about prescription drug abuse, and boost efforts to identify those who abuse prescription drugs by redeeming prescriptions from multiple physicians. Press release: http://www.whitehousedrugpolicy.gov/news/press04/030104.html More information: http://www.fda.gov/oc/initiatives/rxdrugabuse/default.htm U.S. Signs Charter With Mexico, Canada on Public Health Issues On behalf of the United States, FDA has signed the Trilateral Cooperation Charter with health officials from Canada and Mexico to formalize the exchange of public health information of mutual interest to the three countries. Subject areas under the charter include drugs, biologics, medical devices, and food safety. Press release: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01028.html Charter text: http://www.fda.gov/oia/charter.html Pump Approved for Children Waiting to Receive a Heart Transplant FDA has approved the DeBakey VAD Child, a ventricular assist device that will help children aged 5 to 16 with severe left ventricle failure survive long enough to receive a heart transplant. Though similar devices exist for adults, this is the first to be approved for children. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01280.html New Web Site Focuses on Prevention, Diagnosis, Treatment of Heart Disease FDA has created a new Web site that functions as a gateway to information about FDA-regulated products to prevent, diagnose and treat heart disease. The site describes cardiovascular conditions, and it links to detailed information about diagnostic tests, medications, medical devices, and healthy lifestyles. http://www.fda.gov/hearthealth FDA Warns Consumers to Avoid Herbal 'Green Hornet' Product FDA is warning consumers not to buy or use "Green Hornet," a liquid product promoted as an herbal version of the illegal street drug Ecstasy. FDA considers this product to be an unapproved drug because it contains undeclared ingredients found in over-the-counter drugs. FDA is taking the action following reports of severe adverse reactions in four teenagers who used Green Hornet. The store that sold the product to them has stopped selling it. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01026.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Classico Traditional Basil Pesto Sauce and Spread (pine nuts not listed on label) http://www.fda.gov/oc/po/firmrecalls/international02_04.html For a listing of recalls, market withdrawals, and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ PUBLIC MEETINGS March 17 -- FDA/Drug Information Association Workshop: "Combating Counterfeit Drugs"; Washington, D.C. http://www.diahome.org/Content/Events/04027.pdf 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 FDA News Digest. Our next posting will be March 8. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
