FDA warns Bayer about two OTC aspirin products
October 31st, 2008 by Kurt Niland
The Food and Drug Administration sent Bayer Health Care official warnings, stating that the company is marketing and selling two over-the-counter medications that are “illegal,” according to FDA spokeswoman Rita Chappelle.
The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA.
According to Bayer, its Women’s Low Dose Aspirin fights heart disease and osteoporosis with a combination of 81 mg of aspirin and the equivalent of an 8-oz glass of milk in calcium for possible “lifesaving benefits.”
Bayer Heart Advantage combines the same low dose of aspirin with plant phytosterols, molecular entities found in fruits and vegetables that are valuable for their cholesterol lowering properties.
While Bayer’s web site instructs users to talk to their doctors before beginning any aspirin regimen, the message isn’t so clear on the medicine’s packaging. Both Bayer medicines are packaged to appeal directly to consumers, who might be lead to think that they can treat their heart conditions, cholesterol, and osteoporosis with these OTC medicines.
The FDA requires that medicines designed to treat heart disease and osteoporosis be reviewed by its researchers. Federal law also forbids such medications to be sold OTC.
Labeling on Bayer’s Heart Advantage claims that the drug lowers cholesterol. Labeling for Bayer Women’s says that it fights osteoporosis. Improper use of medicines containing aspirin often causes serious side effects such as gastrointestinal bleeding. Aspirin resistance can also have devastating effects on the heart.
Bayer believes that neither products violate FDA regulations, but promises to review the case and report back to the FDA within 15 business days. The FDA indicated in its letter to Bayer that the company would face legal action.
Bayer is already under fire by the FDA and general public for its marketing of Trasylol when ample studies found the drug to be highly toxic to many people.