Tests of Wyeth’s top-selling drug, the antidepressant Effexor, in children found an increased risk of suicidal behavior, the pharmaceutical company is warning medical workers.
In what’s known as a “Dear Doctor” letter, Madison-based Wyeth has sent a two-page letter to health care professionals stating that clinical studies of the long-acting version of the drug, Effexor XR, resulted in increased reports of “hostility and suicide-related adverse events, such as suicidal ideation and self-harm.” None of the pediatric patients in the tests committed suicide.
Neither Effexor nor Effexor XR has been approved for use in patients younger than 18, but doctors often prescribe such “off-label use” for children and adolescents.
“We don’t encourage it, but people are doing it” with Effexor, Wyeth spokesman Doug Petkus said Wednesday.
The Aug. 22 letter, written by Dr. Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, said a study of Effexor XR’s use against depression, 2 percent of the children reported thoughts about suicide, versus none in a comparison group getting a dummy pill, and 2 percent displayed hostility, more than double the rate in the comparison group getting the dummy pill. In a second study of Effexor XR in patients under 18 with generalized anxiety disorder, 1 percent displayed abnormal or changed behavior; none did so in the comparison group.
Wyeth sent the letter to thousands of psychiatrists, general practitioners, other physicians and pharmacists, Petkus said.
Prozac, made by Eli Lilly & Co., is the only antidepressant approved in this country for use by patients under 18.