FDA: 2 Bayer Aspirin Products 'Unlawful'

FDA: 2 Bayer Aspirin Products 'Unlawful'
FDA Calls the Drugs 'Misbranded', Warns of Legal Action Against Bayer if Violations Are Not Promptly Corrected
By Daniel J. DeNoon
WebMD Health News
Reviewed by Louise Chang, MD

Oct. 28, 2008 -- Bayer is "illegally marketing" and making "misleading" claims about two "misbranded" aspirin products, the FDA warns.

The products are Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage. Both are sold over the counter.

According to the FDA:

    * Bayer Women's combines aspirin with calcium. Its label suggests it will strengthen bones and fight osteoporosis.
    * Bayer Heart Advantage combines low-dose aspirin with phytosterols. Its label suggests it will lower cholesterol.
    * Both products' labels suggest they will reduce the risk of heart disease.

The FDA says that drugs claiming to "fight" or otherwise treat osteoporosis require official approval. And FDA says the claim to lower cholesterol is a claim to treat or prevent heart disease and high cholesterol levels -- both of which require new drug approval.

The FDA also says the drugs are "misbranded because their labeling lacks adequate directions for use by consumers." That's because the FDA believes the safe use of the drugs requires diagnosis and supervision by a health care professional -- something it is "not possible" for the labels of over-the-counter drugs to ensure.

In its warning letters to Bayer, the FDA notes that aspirin, calcium, and phytosterols could be marketed separately. But when combined into a single pill, the FDA says the combination of aspirin plus either supplement must be approved as a new drug.

"Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction," the FDA threatens in its official warning letters to Bayer.

The FDA acknowledges that it has received no reports of adverse reactions to either of the two Bayer drugs.

Bayer did not respond to WebMD's request for comment by publication time.