On the FDA website it was announced that it issued warning letters to Bayer for placing two types of over-the-counter aspirin, Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage). on the market without obtaining prior FDA approval.
The agency is unaware of significant adverse events linked to these products, but is concerned because neither has been subject to the approval process. The FDA also found that the products were misbranded because they did not contain adequate instructions for use. In fact, the instructions for the aspirin component for short-term use contraindicated those for phytosterols (Bayer Heart Advantage) and calcium (Bayer Woman’s) which promoted daily use without time limits.
“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.”
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