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
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.