The United States Food and Drug Administration (FDA) recently issued warning letters to the major drug manufacturer, Bayer HealthCare, for unlawfully marketing two over-the-counter Aspirin-based products. The products in question are “Bayer Women’s Low Dose Aspirin + Calcium” and “Bayer Aspirin with Heart Advantage.”
Bayer marketed both medications for uses not approved by the FDA. Labels for the products claimed that they would reduce the risk of heart disease. Labels on Bayer Low Dose Aspirin for women claimed that the drug could be used to combat osteoporosis. Labels on Bayer’s “Heart Advantage” line of aspirin made claims that the drug lowered cholesterol.
Not only were the claims unapproved by the FDA, but, these effects, if proven, would have required that lines of aspirin be dispensed and administered by healthcare professionals. These requirements would make the products prescription medicines, unlawful for over-the-counter sales.
In a statement released by the FDA, Michael Chappell, acting Associate Commissioner for Regulatory affairs, stated: “The FDA considers these products new drugs and thus they must undergo the FDA’s drug approval process. The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”
At present, the FDA is unaware of any cases in which the drugs in question have caused adverse effects in a patient. Manufacturers who fail to comply with FDA regulations and correct violations, cited in warning letters, are subject to legal proceedings.