Life Sciences

FDA rules Effexor XR journal ad misleading

Pharma Compliance Alert, December 19, 2007

The FDA ruled a professional journal ad for Wyeth's Effexor XR misbrands the product because it unsubstantiated superiority claims and minimizes risks associated with taking Effexor, according to a warning letter posted on the FDA's Web site last week.

According to the FDA, claims made in the ad are misleading because the studies they are based on were not properly designed. Other claims in the ad do not have supporting references, but add to the misleading nature of the advertisement.

The FDA also cited Wyeth for improperly claiming the number of patients treated with Effexor and Effexor XR because the data does not identify unique patients.

The FDA wants Wyeth to stop using the ad and submit a letter stating how the company plans to discontinue use of the material, as well as "a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages."

Click here to read the FDA's warning letter.