Skip to main content Back to Top

9/4/2003

Caution Urged in Pediatric Use of Venlafaxine

Cheryl A. Thompson

Wyeth Pharmaceuticals has advised health care professionals to be alert to signs of suicidal ideation in young patients taking venlafaxine, or Effexor.

The Aug. 22 "Dear Health Care Professional" letter noted that the labeling for venlafaxine immediate-release tablets and extended-release capsules now includes a statement about increased reports of hostility, suicidal ideation, and self-harm in children and adolescents who participated in clinical studies of the drug.

Not added to the products' labeling were the frequencies of these adverse events: Hostility or suicidal ideation occurred in 2 percent of the children and adolescents who received the drug for the treatment of major depressive disorder, the letter stated. Abnormal or changed behavior was reported in 1 percent of the participants who received the drug for the treatment of generalized anxiety disorder. These adverse events occurred in less than 1 percent of the children and adolescents who received placebo instead of venlafaxine.

No one in the pediatric studies committed suicide, Wyeth reported.

In the letter, the company reminded clinicians that it does not recommend the use of venlafaxine in pediatric patients. Those already receiving the drug should not abruptly stop treatment, the company warned, because of the risk of discontinuation symptoms. According to venlafaxine's labeling, these symptoms include agitation, anorexia, confusion, and seizures.

Wyeth's communication came nine weeks after the Food and Drug Administration announced that it had started reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in pediatric patients receiving paroxetine as a treatment for major depressive disorder. A United Kingdom Department of Health expert group had earlier announced that it had started studying reports of suicidal behavior in children and adolescents taking paroxetine or another selective serotonin-reuptake inhibitor.

Venlafaxine is not a selective serotonin-reuptake inhibitor.