FDA Warns Wyeth About Effexor Ad

December 20, 2007
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration posted on its website a Warning Letter it sent to Wyeth Pharmaceuticals regarding a journal advertisement for the company?s ?Effexor XR? antidepressant.

Rockville, MD (Dec. 14)-The US Food and Drug Administration posted on its website a Warning Letter it sent to Wyeth Pharmaceuticals (Madison, NJ) regarding a journal advertisement for the company’s “Effexor XR” antidepressant. The agency claims the ad misbrands the drug because “it overstates the efficacy of Effexor XR, makes unsubstantiated superiority claims, in addition to other unsubstantiated claims, and minimizes the risks associated with the use of Effexor XR.”

Citing a study of patients who failed previous antidepressant treatment, Wyeth’s ad claims that nearly 60% achieved remission when they changed their treatment to Effexor XR. FDA says the cited study does not support Wyeth’s claim because it was nonblinded and did not minimize potential bias.

In addition, the agency notes that the cited study lacked a placebo group. Placebo responses are “substantial” in depression studies, according to FDA. Because the study had no placebo group, the agency says, the 60% remission rate was “misleadingly high.”

FDA says the ad asserts that Effexor XR is superior to other antidepressant therapies, but provides no information to support this claim. The agency notes that patients were not randomized to their previous, failed therapy, and that the study thus does not effectively compare Effexor XR to other medications.

The ad’s claim that Effexor XR provides a 92% probability of preventing a new episode of depression in maintenance year two is unsubstantiated, according to FDA, because it is based on a study that was “biased in favor of Effexor XR treatment.” The study in question selected only patients who responded to Effexor XR to continue to the next phase of treatment.

FDA requested that Wyeth pull the journal ad and all similar promotional materials. The agency asked for a written response listing all promotional materials for Effexor XR that are similar to the journal ad, and explaining Wyeth’s plan for discontinuing misleading materials and disseminating truthful information.

Click here for the full text of the Warning Letter.