In response to growing concern over reports that Effexor XR® (venlafaxine HCI), an antidepressant approved to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder, may be unsafe, its maker, Wyeth Pharmaceuticals, has affirmed that no causal link between the drug and homicidal thoughts and actions has been established.
Wyeth said it proactively performs comprehensive reviews of both clinical and post-market data and acts responsibly and in full accordance with regulatory requirements in disclosing safety data regarding its medicines.
Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs at Wyeth, says, “Depression is a serious, complex disease that can be difficult to treat, and patients with depression can have other serious co-morbid psychiatric illnesses. Homicidal thoughts may occur in patients with psychiatric conditions whether or not a patient is being treated with psychotropic medications.”
He went on to say, “It is unfortunate that unsubstantiated and irresponsible allegations have been made that may create undue concern and confusion on the part of patients who benefit from treatment with Effexor XR. However, we always encourage patients to discuss any concerns or confusion they may have with their treating physicians.”
As regulations dictate, Wyeth must document and report safety findings from its clinical trials and post-marketing surveillance data to health boards and regulatory agencies around the world. As well, they conduct periodic safety reviews to ensure the safety profile represented in labeling is accurate and current.
The term “homicidal ideation” first became part of the labeling in Effexor XR in the section entitled “Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor R,” in November 2005 upon FDA approval of Effexor XR for panic disorder. As part of the application for this treatment indication, the company provided the FDA with data including homicidal ideation in a clinical trial of Effexor XR.
Health authorities, including the FDA, recognize an important distinction between Adverse Reactions and Adverse Events. Adverse reactions are thought to result from using a medication, while adverse events have not been proven to occur as a result of taking a medication. An adverse event may or may not be causally related to treatment.