April 17, 2005
The Food and Drug Administration (FDA) has ordered Bayer and GlaxoSmithKline to pull a television ad for their impotence drug, Levitra, charging that it made an unsubstantiated claim and failed to include information about side effects.
The agency said that the companies cannot substantiate claims that Levitra is superior to competitors such as Viagra or that it improves female satisfaction during sexual activity.
"FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Levitra is superior to other treatments," the FDA said in a letter to the companies.
It's the second time the FDA has ordered an impotence ad taken off the air. In November, the FDA told Pfizer Inc. to discontinue a Viagra ad that referred to the actor as "wild thing," saying the company did not state that the drug is for men and failed to mention potential side effects.
The drug companies said the Levitra commercial is a "reminder ad" and does not include the listing of potential side effects that the longer, 45-second version does. The FDA said reminder ads can only call attention to a drug, not say how to use the drug or how well it might work.
Text of Letter
Here is the text of the letter sent by FDA to the drug companies:
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).
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).
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).
Warnings
Warnings for the drug include the following:
Physicians should consider the cardiovascular status of the patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.
