Warning Issued for Kids Taking Effexor
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 new research.
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 findings.
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.
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 XR.
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 been established.
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 new research.
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 findings.
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 XR.
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 been established.
Source...