Bayer Told To Pull Incomplete Levitra Ads

Drug giant Bayer and its marketing partners have been instructed by the U.S. Food and Drug Administration to cease some advertising for Levitra, the firm's hit impotence drug.

In a four page letter sent by a regulatory review officer at the agency, the Levitra ads does not disclose the drug's side effects and makes claims that the FDA believes are unsubstantiated.
Specifically, the FDA wrote, "The TV ad fails to include the specific indication for the drug (namely, treatment of erectile dysfunction) or the required risk information. The TV ad also fails to make adequate provision for dissemination of the FDA-approved labeling.

Bayer has been given until April 27, 2005 to respond to the FDA in writing with its plans to cease promoting Levitra in this fashion.

posted by Consumer Help Web Editorial Team at 8:11 AM |