Warning letters issued for Bayer Heart Advantage, Bayer Women's Low Dose Aspirin + Calcium
TUESDAY, Oct. 28 (HealthDay News) -- Drug giant Bayer HealthCare is illegally marketing two unapproved over-the-counter aspirin medications, the U.S. Food and Drug Administration said in warning letters issued Tuesday.
The products -- Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage -- are unapproved new drugs that require an approved new drug application to be legally marketed, the FDA said. In addition to being labeled as pain relievers, both products claim to reduce the risk of heart disease. Bayer Women's also claims to fight osteoporosis. Neither product has been approved by the FDA for such uses.
Such uses require a health-care professional's diagnosis and supervision, and therefore Bayer Women's and Bayer Heart Advantage can't be labeled for use by consumers and sold over-the-counter, the agency explained.
Bayer Heart Advantage combines aspirin and phytosterols, which the label claims helps lower cholesterol levels. Bayer Women's combines aspirin and calcium carbonate.
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process. The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process," Mike Chappell, the FDA's acting associate commissioner for regulatory affairs, said in an agency news release.
In addition, the FDA said Bayer Women's and Bayer Heart Advantage has labeling that lacks adequate directions for use by consumers. This means that directions aren't written in a way that consumers can use the products safely for their intended purposes without the supervision of a health-care professional.
"The marketing of these unapproved drugs is troubling," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in the news release. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health-care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
FDA officials said they weren't aware of any significant adverse events associated with Bayer Women's or Bayer Heart Advantage.
If companies fail to resolve violations cited in FDA warning letters, they face enforcement action such as injunctions and/or seizure of illegal products.
The FDA has more about its drug approval process.
-- Robert Preidt
SOURCE: U.S. Food and Drug Administration, news release, Oct. 28, 2008
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