-- Robert Preidt
MONDAY, Feb. 6 (HealthDay News) -- Antidepressant drugs such as
Prozac do not raise suicide risk in young people, a new study
The finding should help reassure doctors about prescribing
antidepressants to youngsters, said first author Robert Gibbons, a
professor of medicine, health studies and psychiatry at the
University of Chicago.
In 2004, the U.S. Food and Drug Administration ordered a "black
box warning" for Prozac (generic name fluoxetine) after data from
25 clinical trials suggested the medications increased the risk of
suicidal thoughts and behaviors in children and young adults up to
But this analysis of data from 41 clinical trials involving a
total of more than 9,000 patients identified no such link in either
adults or children.
"I hope that the [black box] warnings will not prevent depressed children and adults from getting treatment for depression," Gibbons said in a university news release.
One expert agreed. Dr. Mark Russ, director of psychiatric
services at Zucker Hillside Hospital in Glen Oaks, N.Y., said the
study "argues that treatment with the antidepressant medications
examined ... is not associated with a higher risk of suicidal
ideation and behavior, and should not be withheld for this
The study also found that Prozac and another antidepressant
called Effexor (venlafaxine) reduced suicidal behavior and
depression in adults and seniors.
For their study, Gibbons and colleagues used clinical trial data
-- some of it unpublished -- from drug makers and a large U.S.
National Institute of Mental Health collaborative study of Prozac
and Effexor. The study -- funded by the U.S. National Institute of
Mental Health and the U.S. Agency for Healthcare Research and
Quality -- appears online Feb. 6 in the journal
Archives of General Psychiatry.
To assess the effects of antidepressants in children, the
researchers examined four trials of Prozac. Until recently, it was
the only antidepressant approved for use in children, according to
a University of Chicago Medical Center news release.
The studies showed that the drug reduced depression symptoms in
children and did not have any effect on their suicide risk.
The results from the trials of Prozac and Effexor in adults and
seniors found that the drugs reduced both depression symptoms and
suicide risk. This suggests that antidepressants cut the suicide
risk in adults and seniors by easing patients' depression, the news
"I think that this paper supports the general idea that the effects of antidepressants in kids and adults are not really the same, since we don't see anything but beneficial effects of antidepressants in adults and geriatrics," Gibbons said in the release. "In kids, we don't see a harmful effect, but we do see a disassociation between the beneficial effects on depression and the potential beneficial effect on suicide."
He added: "This raises continued questions about what's going on
in children. Maybe children think about suicide in part because of
depression, but also maybe due to other reasons not related to
depression that are not affected by antidepressants."
One expert welcomed the study findings.
"This very important study goes a long way to undoing what I consider an ill-conceived FDA issued black box warning for antidepressants and risk of suicide in children and adolescents," said Dr. Norman Sussman, a psychiatrist at NYU Medical Center in New York City. "It was a finding of an increased rate of ideation [suicidal thoughts] and attempts during some clinical trials that formed the entire basis for the FDA black box warning. Yet, as the authors of the current paper point out, no actual suicides occurred in these [trials]."
According to Sussman, who is also professor of psychiatry at NYU
School of Medicine, the warning led to a drop in antidepressant
prescriptions for depressed children. "In what I hope will lead to
a corrective series advisories that encourage antidepressant use,
the results of this study confirm what clinicians have observed all
along, namely, treatment with antidepressants decreases suicide
risk," he said.
Gibbons agreed. "The greatest cause of suicide is untreated or
undiagnosed depression," he said. "It's very important that this
condition be recognized and appropriately treated and not discarded
because doctors are afraid to be sued."
The Nemours Foundation has more about
children and depression.
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