Aspirin Supplements Get Bayer An FDA Warning

The FDA sent two warning letters to Bayer saying these supplements are illegal when combined with aspirin and the German based company is in violation and “prompt action” needs to be taken. The drugs contain calcium and phytosterols, dietary supplements that have yet to be proven to be effective on consumers.

In one of the warning letters dated October 27th, the FDA wrote: “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 isn’t saying that the products have harmful side effects, only that the marketing of the product is confusing. Bayer aspirin has been a staple in many household medicine cabinets for years.

Bayer Aspirin with Heart Advantage claims to help control cholesterol, while Bayer Women’s Low Dose Aspirin plus Calcium claims to help strengthen bones and prevent osteoporosis. The FDA says neither of these statements has been proven to be true, yet it is unclear if the agency will seek a recall of the medications. Bayer has 15 days in which to respond. If the company does not resolve these violations, they risk agency sanctions like injunctions or seizures, according to the FDA.

Bloomberg reports that in a telephone interview, Bayer spokeswoman, Anne Coiley said, “Bayer stands behind the marketing of both products.” The company is currently reviewing the FDA warning letters and has no further comment concerning the actions against their aspirin products.

Calcium has been known to help fight osteoporosis, the bone thinning disease; and phytosterols can help lower LDL (bad) cholesterol. Neither of these products has been approved by the FDA. Both are supplements that when taken alone may have an effect on your health. However, the FDA has not provided any direction on the supplements, neither positive nor negative, thus keeping consumers confused of its health benefits.

In 2007 Bayer aspirin had sales of $460 million translating into 1.5% of the companies’ total revenue of $32.4 billion, this according to Bloomberg financial data.

Bayer has marketed their Heart Advantage product as an aspirin that can reduce heart attack risk by up to 30%. Yet there is a warning on their website that this drug is not to be used as a replacement for cholesterol lowering medications.