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Effexor XR Claims in Ad Draw FDA Rebuke of Wyeth

Dec 18, 2007 | Parker Waichman Alonso LLP

Ads for Effexor XR in a medical journal are misleading, the Food & Drug Administration (FDA) says, prompting the agency to issue a warning letter to Wyeth, the maker of the widely-used antidepressant.  The FDA said the wording of the ad overplays the benefits of Effexor XR and minimizes dangerous side effects.

Effexor XR is an extended version of the original Effexor.  Effexor is the top selling anti-depressant in the world, according to Wyeth, and Effexor drugs reaped sales of $958 million in the third quarter of 2007 alone.

Effexor and Effexor XR work by increasing the brain’s uptake of the neurotransmitters serotonin and norepinephrine, both of which effect mood.  But both drugs are known to have dangerous side effects, including an increased risk of suicidal thoughts and behavior when used in children and adolescents, as well as hypertension and serious withdrawal symptoms. Despite such serious side effects, Effexor and Effexor XR are marketed by Wyeth as better alternatives to antidepressants like Paxil, Prozac and Zoloft.

Now, the FDA is charging that an ad which appeared in a medical journal makes “unsubstantiated superiority” claims about Effexor XR.  The FDA criticized several claims in the ad, including citation of a study claiming that said Effexor XR prevented a depressive episode in 92 percent of cases, versus 55 percent for a placebo. The agency said that claim is "based on a study that is inadequate."

The FDA also faulted Wyeth's claim that 20 million people have been treated with the Effexor XR, a statistic the FDA said is based on suspect data.  Because people may associate the number of people treated with quality, this claim "may mislead consumers and healthcare providers," FDA wrote.

This is not the first time Wyeth has been accused of making misleading Effexor claims.  Last month, Dr. Daniel Carlat recounted his experiences as a Wyeth-paid Effexor lecturer in the New York Times.  According to Dr. Carlat, the Effexor information Wyeth instructed him to convey during visits to physician offices was often incomplete, downplayed risks, and was skewered to favor Effexor over other drugs.  When Dr. Carlat, uncomfortable with the Wyeth-provided script, altered it to include more complete data on hypertension, he was visited by a district manager, who expressed concern that the doctor was not exhibiting enough “enthusiasm” in his talks.   Dr Carlat quit lecturing for Wyeth shortly after that episode.

The FDA has ordered Wyeth to cease running  ads for Effexor XR that make misleading claims in medical journals.  The company must also provide the FDA with a list of other Effexor XR marketing materials that make similar claims, as well as a detailed plan for discontinuing the use of such materials.   Wyeth has until December 21 to respond to the FDA Effexor XR warning letter.  

The Effexor XR ads in question are no longer running, but a spokesperson for Wyeth told Reuters that the company believes they were “responsible.”