Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.


"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "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."

Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.

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