Bayer Products Questioned by the FDA

Bayer has been given fifteen days by the FDA to take action regarding allegations that the company is marketing and selling two aspirin products that have not been given FDA approval. The company has been told to comply by either ending sales of their Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin plus Calcium or to proceed with clinical trials, in order to gain the required FDA approval.

The German company manufactures the Heart Advantage product, which is aspirin with a plant extract called phytosterois, that the company claims on the products label has been proven to help lower cholesterol,  and Bayer’s Women’s Low Dose Aspirin, aspirin combined with calcium carbonate that the company states on the label helps to fight osteoporosis. While Bayer’s aspirin product has FDA approval, the FDA states when the product is altered by adding other supplements it is a new product, and therefore requires new research for those products to gain FDA approval.

The FDA allows traditional pain relievers to be sold over the counter without approval as long as the product has proper labeling and directions for consumers. However, with the two drugs in question the FDA feels Bayer has gone beyond these regulations, and that their labeling misrepresents the medications by claiming the added ingredients for each medication help to fight diseases, such as heart disease and osteoporosis. Any drug used to treat heart disease or osteoporosis has to be reviewed by the FDA and cannot be sold over the counter. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, finds the marketing of the unapproved drugs bothersome and “the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events.”

Anne Coiley, a Bayer spokeswomen, explained that Bayer intends to look over the warning letters issued by the FDA and respond, but the company “stands behind the marketing of both products” and that the products labeling gives direction for consumers  to talk with their doctors about taking the medication. The FDA states that those companies who do not resolve FDA violations raised in warning letters will risk possible injunctions or seizures.