Effexor

Effexor has been connected with suicide, suicidal thoughts and actions and incidents of self-harm.

In what is known as a "Dear Doctor" letter, Madison-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 Wyeth letter states.

In March 2004, the FDA issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

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.

Additionally, 2 percent displayed hostility, more than double the rate in those getting the 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.

About Effexor

Effexor (Venlafaxine Hydrochloride) is prescribed for the treatment of severe mental depression and certain anxiety disorders.

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.

Note - Do not change medications without first consulting your doctor.

Please fill out the form below to contact a Case Manager.