WASHINGTON, Dec 14 (Reuters) - A Wyeth WYE.N ad for the widely used anti-depressant Effexor XR minimizes risks and overstates effectiveness, U.S. regulators said in a letter released on Friday.
Ads for the drug in a medical journal are misleading and make “unsubstantiated superiority” claims, while downplaying risks, the U.S. Food and Drug Administration said in the Dec. 10 letter, posted on the FDA Web site on Friday.
Many anti-depressants, including Effexor XR, carry labeling that warns of the risk of suicidal thoughts and behavior in children and adolescents.
Effexor is the top selling anti-depressant in the world, according to Wyeth. Effexor drugs reaped sales of $958 million in the third quarter of 2007 alone. Effexor XR is an extended version of the original Effexor.
Wyeth spokesman Doug Petkus said the company believes the ads, which are not now running, are “responsible.” The Madison, New Jersey-based drugmaker is in talks with the FDA to resolve the dispute, he said.
The FDA criticized several claims in the ad, including citation of a study claiming that the probability of preventing a depressive episode in 92 percent of cases, versus 55 percent for a placebo. FDA said that claim is “based on a study that is inadequate.”
Wyeth’s claim that 20 million people have been treated with the drug is based on suspect data and misleading, FDA said in the letter.
Because people may associate the number of people treated with quality, this claim “may mislead consumers and healthcare providers,” FDA wrote.
FDA gave Wyeth until Dec. 21 to submit a written response to the agency. (Reporting by Kim Dixon; Editing by Gary Hill)