October 29th, 2008

Truth in Advertising – Bayer Warned about Unsubstantiated Aspirin Claims

Bayer AspirinAccording to Federal regulators from the Food and Drug Administration, Bayer has been illegally marketing two aspirin products that make unsubstantiated health claims about fighting heart disease and osteoporosis.

In both cases, the aspirin has been combined with a dietary supplement into a single pill.

Aspirin is often recommended by doctors to treat general aches and pains and in small doses (baby aspirin) as a blood thinner for patients with heart disease.

The two products in question:

  • Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)
  • Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s)–aspirin combined with calcium

These product formulations are not approved by FDA. The FDA has issued a warning letter to the Bayer Corporation.

Why the Warning?

Bayer has been marketing these products as pain relievers and as treatments for heart disease and osteoporosis. They claim that Bayer Heart Advantage helps in “reducing the risks of heart disease.”

The labeling for Bayer Women’s also claims that the product helps “fight” osteoporosis.

Treatments for heart disease and osteoporosis must be reviewed by government scientists and cannot be sold over the counter.

In addition the FDA has determined that these products have inadequate and misleading directions and warnings. Both products lack adequate directions and warnings for their safe use by consumers.

According to ABC News these results were discovered by the House Energy and Commerce Committee, has been investigating drug advertising and the FDA’s oversight of pharmaceutical manufacturers for over a year.

Sources:

October 28, 2009. FDA Warns Bayer Over Claims on 2 Aspirin Products: Federal Regulators Call Health Claims Unsubstantiated. ABC News.

U.S. Food and Drug Administration. October 28, 2009. FDA Warns Bayer About Two Unapproved Aspirin Products. Consumer Updates.

Image Source: Esra Su. Aspirin. Royalty Free Use.

Add comment October 29th, 2008


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