Healthy Skepticism Library item: 1089

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

Hankin Joan.
Levitra® (vardenafil HCl) Tablets
FDA 2005 Apr 13
http://web.archive.org/web/20090118215108/http://www.fda.gov/cder/warn/2005/Levitra.pdf

Abstract:

This letter notifies Bayer Pharmaceuticals Corporation (Bayer) and, by copy, Schering Corporation
(Schering) and GlaxoSmithKline (GSK), which market Levitra on behalf of Bayer, that the Division of
Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a direct-to-consumer
television advertisement (TV ad) for Levitra® (vardenafil HCl) Tablets (Levitra) submitted under cover
of Form FDA 2253 (entitled “My Man” ID# LEV680R0/PD3816504). The TV ad fails to disclose the
drug’s indication, fails to include information relating to the major side effects and contraindications,
and fails to make adequate provision for dissemination of the FDA-approved labeling in violation of
the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 352(n), and FDA implementing
regulations, 21 CFR §§ 202.1(e)(1) and (e)(3). Moreover, the TV ad is misleading because it contains
representations or suggestions that Levitra is superior to other erectile dysfunction treatments when
this has not been demonstrated by substantial evidence or substantial clinical experience. See 21 CFR
§ 202.1(e)(6)(ii).