FDA Issues Warning Letters to Bayer over Unapproved Aspirin Products

By Aaron Poehler

Published on October 28, 2008

In warning letters issued today, the U.S. Food and Drug Administration stated that two over-the-counter aspirin-based medications marketed by German conglomerate Bayer AG make unsubstantiated health claims about fighting osteoporosis and heart disease.

According to the FDA, Bayer's products Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium each contain dietary supplements which have not been proven. Bayer Aspirin with Heart Advantage contains the plant extract phytosterois, which is claimed as a cholesterol-lowering supplement, while Bayer Women's Low Dose Aspirin + Calcium includes calcium carbonate intended to help fight osteoporosis.

The text of the warning letters indicated to Bayer that all new treatments for heart disease and osteoporosis must be reviewed by FDA officials before marketing and that neither product has received the necessary approvals. The letters specified a timeframe of 15 days for Bayer to respond to the warnings.

FDA warning letters are not legally binding, but companies that do not comply with the warnings may face legal action.

While Bayer had not officially responded to the warnings as of Tuesday morning, a Bayer spokesman stated that the company stands behind both of the indicated products as well as all marketing claims made on their behalf.

A current investigation by the U.S. House of Representatives Energy and Commerce Committee is looking into whether Bayer misled the public in its marketing of Bayer Aspirin with Heart Advantage.

 

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