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FDA Warns Bayer of Unapproved Drugs

-October 28, 2008

The Food and Drug Administration (FDA) warned Bayer HealthCare of two over-the-counter (OTC) products that contain aspirin, Oct. 28. The FDA warned that they do not approve the two products, both of which mix aspirin with a dietary supplement.

The FDA has not approved the two new pills, because it has not yet tested their effectiveness and safety. According to the FDA, Bayer is marketing both pills as pain relievers and as aids in reducing the risks of heart disease.

The two aspirin-containing products are:

• Bayer Heart Advantage: Bayer Aspirin combined with phytosterols

• Bayer Women’s: Bayer aspirin combined with calcium
 
While the FDA does allow some OTC drugs to be marketed without having full approval, the two drugs at hand do not meet the requirements that would allow that to be the case.

FDA Finds Bayer’s Marketing Problematic
According to the FDA, Bayer’s marketing strategies for the two drugs are problematic and may lead to confusion among consumers:

• Bayer has been marketing the new drugs as OTC drugs, when in fact any drugs that are marketed for reducing the risks of heart attack require supervision from a physician.

• The FDA has also stated that both the drugs have misleading directions and warnings for consumer use and safety.

No Adverse Events Related to the Drugs
Despite the FDA’s refusal to approve either one of the aspirin-containing drugs, the FDA noted that there have not been any documented adverse events related to the drugs. Agency members have expressed, however, concern for the new drugs’ safety and strongly advise that all consumers who are using the drugs to speak to their physicians about switching to approved drugs that provide similar treatments.

(Source: FDA)

Have you or someone you know suffered injuries due to an unapproved or recalled medication? If so, contact us to schedule a private consultation with a skilled defective drug attorney who will advocate for your legal rights and will fight to get you the compensation you need to cover any medical and emotional damages.

 

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