A Medical Accountability Network's representative discovered a labeling change to Effexor XR from Wyeth in June, 2006 in the FDA's MedWatch newsletter from November. The Madison, N.J.-based drug company did not send letters to doctors or issue warning labels at any time.
In approving Wyeth's application to use Effexor for panic disorder, the FDA wanted homicidal ideation listed as a rare adverse event, defined as something not proven to be linked to the drug. Wyeth never notified doctors or issued warning labels because it found no causal link between its drug and homicidal thoughts, according to a Wyeth official.
In its typical boiler response, Wyeth's mouthpiece added that the drug is safe and effective.
