Wyeth is warning doctors that tests show its antidepressant Effexor caused an increased risk of suicidal behavior in children.
In what is known as a “Dear Doctor” letter, Madison, N.J.-based Wyeth is telling 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.” No children in the tests committed suicide.
“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, the letter states.
The caution comes after U.S. and British regulators in June said that no one under age 18 should take GlaxoSmithKline’s antidepressant Paxil because it could increase a child’s risk of suicide attempts.
The U.S. Food and Drug Administration is investigating how newer antidepressants affect children. Even though Eli Lilly & Co’s Prozac is the only antidepressant approved for treating children, some doctors are prescribing other medications for minors.