The FDA’s Division of Drug Marketing, Advertising, andCommunications says a Wyeth professional journal ad for Effexor XR (venlaxineHCl) tablets was misleading because it overstated the drug’s efficacy, madeunsubstantiated superiority claims and other unsubstantiated claims, andminimized risks.
A recent warning letter says Effexor is indicated fortreating major depressive disorder, among other things. The labeling says itsuse is associated with a number of serious risks and includes a black-boxwarning regarding suicide. There are also warnings for worsening and suiciderisk, the need to screen patients for bipolar disorder, the potential forinteractions with MAOIs, serotonin syndrome, hypertension and mydriasis.
The warning letter says the ad’s claim that nearly 60% ofpatients who failed previous antidepressant treatment achieved remission whenchanged to Effexor was based on a study that for several reasons failed tosupport the magnitude of the claimed response rate and any conclusion thatEffexor is superior to alternatives.
The letter says, by selecting only patients who responded toEffexor XR to continue to the next treatment phase, and by failing to properlyaccount for potential recurrent depressive episodes in those patients whodiscontinued Effexor XR, the study design was biased in favor of Effexor XR.
Finally, the letter says, the ad’s claim thatover 20 million patients were treated with Effexor was also misleading.
From the February 01, 2008 Issue of MM+M - Medical Marketing and Media
