Effexor (generic name: venlafaxine), also known as venlafaxine hydrochloride, is prescribed for the treatment of severe mental depression. The drug is also used to treat certain anxiety disorders and relieve symptoms of anxiety. It has been linked with suicide, suicidal ideation, suicidal behavior, and suicide attempts. Effexor is an SNRI antidepressant (serotonin and norepinephrine reuptake inhibitor).
Manufacturer Wyeth Pharmaceuticals warned doctors that tests showed that Effexor caused an increased risk of suicidal behavior in children. In what is known as a "Dear Doctor" letter, Wyeth told health professionals that clinical studies of the long-acting version, Effexor XR, found a higher incidence in children of "hostility and suicide-related adverse events, such as suicidal ideation and self-harm."
"You should be alert to signs of suicidal ideation in children and adolescent patients prescribed Effexor or Effexor XR (and) reassess the benefit-risk balance" for each patient, Wyeth's letter stated.
The caution came on the heels of U.S. and British regulators' announcement that no one under 18 should take the popular antidepressant Paxil because it could increase a child's risk of suicide attempts. Those pediatric patients who were already taking Paxil were told to stop use gradually, under a doctor's supervision.
Wyeth's letter, written by Dr. Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, said that in a study of Effexor XR's use against major depression, 2 percent of the children reported thoughts about suicide, versus none in a comparison group getting a placebo pill.
Additionally, 2 percent displayed hostility, more than double the rate in those getting a placebo. In a study of patients under 18 with generalized anxiety disorder, 1 percent displayed abnormal or changed behavior; none did so in the comparison group.
The letter notes that the studies did not show Effexor relieves depression or anxiety in children.
Effexor was first approved in 1993; along with the once-a-day Effexor XR, it now generates $2.1 billion in annual sales for Wyeth, making it the company's biggest-selling drug.
