The FDA's Division of Drug Marketing, Advertising, and Communications says a Wyeth professional journal ad for Effexor XR (venlaxine HCl) tablets was misleading because it overstated the drug's efficacy, made unsubstantiated superiority claims and other unsubstantiated claims, and minimized risks.

A recent warning letter says Effexor is indicated for treating major depressive disorder, among other things. The labeling says its use is associated with a number of serious risks and includes a black-box warning regarding suicide. There are also warnings for worsening and suicide risk, the need to screen patients for bipolar disorder, the potential for interactions with MAOIs, serotonin syndrome, hypertension and mydriasis.

The warning letter says the ad's claim that nearly 60% of patients who failed previous antidepressant treatment achieved remission when changed to Effexor was based on a study that for several reasons failed to support the magnitude of the claimed response rate and any conclusion that Effexor is superior to alternatives.

The letter says, by selecting only patients who responded to Effexor XR to continue to the next treatment phase, and by failing to properly account for potential recurrent depressive episodes in those patients who discontinued Effexor XR, the study design was biased in favor of Effexor XR.

Finally, the letter says, the ad's claim that over 20 million patients were treated with Effexor was also misleading.