Bayer Gets FDA Warning

Jamie Sheller

Attorney
(866) 735-1102 Ext 475

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Aspirin is a pain reliever, and is used as a blood thinner in people with heart disease.  The FDA has issued warning letters to Bayer about two of its aspirin products, Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin With Health Advantage.  According to the FDA, Bayer has not provided evidence that these drugs are effective treatments for heart disease and osteoperosis.  Bayer argues that the two aspirin products are effective for promoting healthy hearts and bones, but adds that consumers should check with their doctors about treatment decisions.  However, the FDA says that osteoperosis and heart disease treatments cannot be sold over-the-counter, and must go through study and review.  The FDA is responsible for that approval process. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."  Though FDA warning letters are not legally binding, if a company ignores the warning, it can be sued by the FDA.  Bayer plans to respond to the warning letters within the allotted time frame.