Warnings, Columns-Drugs & Supplements, April 2005

FDA Says Levitra TV Ad Misleading

ROCKVILLE, Md -- A direct-to-consumer television ad for the Levitra erectile dysfunction drug "fails to disclose the drug's indication," as well as information relating to major side effects, the U.S. Food and Drug Administration said in an April 15 warning letter to manufacturer Bayer Pharmaceuticals Corp.

Bayer also failed to "make adequate provision for dissemination of the FDA-approved labeling in violation of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 352) and FDA implementing regulations," according to a letter sent to the company from FDA Consumer Protection Analyst Joan Hankin.

"Moreover, the …