The FDA Tuesday sent warning letters to Bayer HealthCare concerning two unlawful, over-the-counter aspirin products—Bayer Heart Advantage and Bayer Women's.
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application to be legally marketed, according to the agency. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease; Bayer Women's is also labeled for use in “fighting” osteoporosis. Neither product has been approved by the FDA for such uses.
The FDA said that new drug uses require a healthcare professional's diagnosis and supervision, and therefore the products cannot be labeled for use by consumers and sold over-the-counter (OTC).
“The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process,” said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs.
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet, while Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the FDA said it regulates the product as a drug.
According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol. The FDA said that “although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease.”
“The marketing of these unapproved drugs is troubling,” said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.
The FDA said it is not aware of significant adverse events associated with the products.