Warning Issued For Kids Taking Effexor
Use of Antidepressants for Childhood Depression Under Scrutiny
Sept. 4, 2003 - Children who take certain antidepressants
intended for adults may have a higher risk of suicidal behavior, according to
In a letter sent to doctors, Wyeth Pharmaceuticals is warning
that studies have shown that children and teens taking its drug Effexor XR to
treat childhood depression are more likely to report feelings of hostility and
suicidal behavior than those taking a placebo.
It's the second such warning issued in the last three months
about an increased risk of suicidal behavior associated with the use of adult
antidepressants in children and adolescents. In June, the FDA recommended that
the antidepressant Paxil should not be used to treat childhood depression after
British researchers noted a higher rate of suicidal thinking and suicide
attempts among youths taking it.
But experts say that children and teenagers using these drugs
to treat depression should not abruptly stop using them in response to these
Instead, the American Academy of Child and
Adolescent Psychiatry advises that parents check with their child's doctor
concerning the medication, as an individual child's response to the
medication is something that needs to be addressed on
a case-by-case basis.
Heightened Suicide Risk
According to Wyeth's letter, which was sent to health care
providers on Aug. 22, clinical studies in children ages 6-17 showed increased
reports of hostility and suicide-related adverse events among those taking
Effexor XR compared with those on the placebo. These events included suicidal
thinking and self-harm, and they occurred at a rate twice that found with the
placebo (2% vs. less than 1% for hostility and 2% vs. 0% for suicidal thinking
among those treated for childhood depression).
No suicides occurred during these clinical trials.
"We made the discovery after evaluating clinical data from
ongoing and some completed pediatric trials, and we felt it was important to
provide this information to health care practitioners," says Wyeth
spokesman Doug Petkus. Wyeth is a WebMD sponsor.
In light of these findings, Wyeth has updated the prescribing
information for the drug to include details on the increased risk of hostility
and suicidal behavior in individuals under 18 years of age who take Effexor
Petkus says the FDA was notified in advance about the letter
and supported Wyeth's action.
Effexor XR is a longer acting version of Effexor. The FDA has
approved Effexor XR for the treatment of major depression and social anxiety
disorder in adults. But the drug has not been approved for use in children, and
Wyeth says its safety and effectiveness in children and adolescents has not
Dangers of Prescribing Adult Drugs to Kids
"What's happening is that you've got physicians and
psychiatrists who are prescribing antidepressants, including Effexor, to this
[pediatric] population. Although we don't recommend it, and it's not approved
for use in this population," Petkus tells WebMD.