Last Friday the FDA issued a warning letter to Wyeth Pharmaceuticals Inc. over an advertisement for Effexor XR published in a professional journal. The FDA states that the letter overstates the efficacy of Effexor XR and makes unsubstantiated claims of the drug’s superiority to other treatments. The letter also claims that the ad understates the risks associated with the use of Effexor XR. These claims among others deemed “unsubstantiated” by the FDA have prompted the response by the FDA.
The journal ad claims that “In an open-label study of patients who failed previous
antidepressant treatment, nearly 60% achieved remission when changed to EFFEXOR XR” (emphasis original). This claim is misleading because it suggests that Effexor XR is more effective than has been demonstrated by substantial evidence or substantial clinical experience. In addition, by implying that Effexor XR can successfully treat patients who have not responded to other antidepressant treatments, the claim misleadingly suggests that Effexor XR is superior to other antidepressant treatments when this has not been demonstrated by substantial evidence or substantial clinical experience.
The FDA has order Wyeth to immediately cease dissemination of the advertisement in question and to submit a plan to provide a corrective message to those who received the violative advertisement.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.