FDA News Digest
March 31, 2008
_____________________________________IN THIS WEEK’S ISSUE
› FDA is advising consumers not to buy or use “Blue Steel” or “Hero” products, marketed as dietary supplements throughout the United States, because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect blood pressure level. They are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They are labeled as dietary supplements but do not qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in the ED drug Viagra.
› FDA also is advising consumers not to buy or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
› Honduran Cantaloupes grown by Agropecuaria Montelibano
Reason for recall: Salmonella contamination
› Certain batches of Stonyfield Organic Fat Free Blueberry Yogurt, 6-oz. cups
Reason for recall: reported plastic or glass fragments in product
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
Recommendations Made on Devices That Treat Blocked Heart Arteries
FDA has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, which are devices used to treat blocked heart arteries. FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines outline the agency’s recommendations for providing data to better address the clot issue and other potential safety concerns.
25 Drugs, Biologics Identified for Safety Plan Requirements
FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). FDA can require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. Manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.
FDA Seeks Civil Penalties from California Maker of Hearing Aids
FDA is seeking a $2.2 million penalty against California hearing aid manufacturer Advanced Bionics, LLC, for violations of federal law, including manufacturing standards violations and the failure to notify the agency of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks. The hearing aids pose a risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.
To view an archive of recent FDA news releases, go to
CONSUMER HEALTH INFORMATION
Each week, we offer links to articles about FDA activities and FDA-regulated products. In the spotlight this week:
› Taking a Close Look at Ultrasound
› Avoid Fetal “Keepsake” Images, Heartbeat Monitors
To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html