The United States Food and Drug Administration (FDA) sent a letter to Bayer Pharmaceuticals, Schering Corporation and GlaxoSmithKline today concerning their review of direct-to-consumer television advertising for the prescription drug Levitra (vardenafil HCL).

The television ad under discussion, entitled “My Man,” fails to disclose the drug’s indication, fails to include information about major side effects of the medication, and fails to make adequate provisions for dissemination of FDA-approved labeling. It also contains suggestions that Levitra is superior to other treatments for erectile dysfunction treatments, when this has not been demonstrated by substantial clinical evidence. For these reasons the FDA is requesting that Bayer immediately cease the dissemination of this ad and supporting promotional materials. Schering and GlaxoSmithKline market Levitra on behalf of Bayer.

The FDA concluded that the totality of the television ad, which shows a woman speaking directly to the camera while video flashes-back to moments when she and her “man” appear romantically involved, suggests that Levitra will provide a satisfying sexual experience from the female partner’s perspective. The ad does not indicate that Levitra is indicated for the treatment of erectile dysfunction nor does it list the major side effects and contraindications of the drug.

Levitra may have negative effects in patients taking alpha-blockers because it can produce hypotension. Other adverse effects associated with Levitrainclude headache, flushing, rhinitis, dyspepsia and nausea.

In addition, the woman in the ad states that Levitra is “the best way to experience that difference,” implying that Levitra is superior to other treatments for erectile dysfunction. The FDA stated that it is unaware of substantial clinical evidence to back up this claim.