Bayer Warned Over Misleading Claims for Aspirin SupplementsOct 29, 2008 | Parker Waichman LLP Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage include unproven claims. The FDA also said the two products are being sold illegally.
Bayer Aspirin with Heart Advantage contains plant sterols and claims on its packaging to help control cholesterol, while Bayer Women's Low Dose Aspirin + Calcium claims to help strengthen bones and prevent osteoporosis. While vitamin and herb supplements are generally not subject to FDA approval, adding them to already-approved drugs makes them entirely new products that must be subject to FDA review before being sold, the agency said.
"These statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used," the FDA wrote in an Oct. 27 warning letter to the company released on Tuesday.
The FDA has not yet directed Bayer to remove the aspirin supplements from the market, but the letter gave the company 15 days to respond. Bayer basically has two options for dealing with the problem: stop selling the products or conduct clinical trials and seek FDA approval. If Bayer does not act, the FDA could seize the product, seek an injunction or take other legal steps.
For its part, Bayer says it is reviewing the FDA warning letter, but insists it stands by its product. In a statement, Bayer said its advertisements tell buyers to check with their doctors before taking the combination aspirins. Bayer Aspirin with Heart Advantage also tells consumers the drug does not replace cholesterol-lowering medication.
Earlier this month, the FDA cited Bayer for running two TV ads for its Yaz birth control pill that the agency said were misleading. In a letter dated October 3, the FDA said that the Bayer TV ads implied that Yaz was approved to treat the symptoms of premenstrual syndrome (PMS). According to the FDA, Yaz is only approved for premenstrual dysphoric disorder, a more serious condition that causes anxiety, tension, persistent anger and other symptoms. In its letter, the FDA said there is no evidence that Yaz eliminates the PMS symptoms described by the ads.
The FDA also said that both ads left the impression that Yaz is approved as a treatment for acne of all severities when this is not the case. Yaz is only approved to treat moderate acne.
The FDA also said that the ads contained fast-moving images and background music, that might be distracting to viewers. These elements were aired while information about potential Yaz side effects - including potentially life-threatening blood clots - was described. The FDA was concerned that the presentation would distract viewers from the ads' important safety information.