Bayer HealthCare Receives FDA Warning Letters for Illegally Marketing Two Unapproved Drugs
November 3, 2008
Bayer HealthCare today received warning letters from the U.S. Food and Drug Administration (FDA) concerning two illegal, over-the-counter (OTC) aspirin products the drug company is marketing: Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The FDA warning letters state that the OTC medications, which contain a mixture of aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed.
Although the FDA allows some drugs meeting specific labeling, formulation, and indications (uses) requirements to be marketed without first obtaining agency approval, the new Bayer aspirin products fail to meet these requirements for several reasons.
To begin with, both products are labeled for use in reducing the risks of heart disease, and Bayer Women’s is also labeled for use in “fighting” osteoporosis. But these drug uses require a health care professional’s diagnosis and supervision. Therefore, FDA regulations prohibit these products from being labeled for these uses and sold over-the-counter (OTC).
In addition, the FDA says that Bayer Heart Advantage and Bayer Women’s are misbranded because their labeling lacks adequate directions for consumers. In order for an OTC drug to have adequate directions for consumer use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. Because the use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use, it is impossible, in OTC drug product labeling, for these products to have adequate directions for their intended uses.
Moreover, the products also are misbranded because their labeling is misleading and lacks adequate warnings. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products’ daily use without any time limits. The result is a mixed message about the products’ purposes and the length of time for which the products can be safely used.
Because Bayer Heart Advantage and Bayer Women’s do not meet the conditions required to be exempt from needing FDA approval, Bayer Heart Advantage and Bayer Women’s are therefore unapproved new drugs and are being sold unlawfully. If Bayer HealthCare fails to resolve the violations outlined in the FDA warning letters, the company faces the risk of enforcement action, such as injunctions and/or seizure of illegal products.
Bayer Women’s Aspirin & Bayer Heart Advantage Side Effects Attorneys
If you took Bayer Women’s or Bayer Heart Advantage and experienced adverse side effects, you may be entitled to compensation for your injuries. Contact us today for a free and confidential case evaluation.