Did FDA Teen Suicide Warning Backfire?
After Antidepressant Warning, Youth Prescriptions Down, but Suicides Way Up
Sept. 13, 2007 - Warnings that antidepressants may increase teen suicides appear to have backfired, a new study suggests.
The study shows that a steep drop in antidepressant prescriptions for children and teens followed the FDA and European drug authority warnings. At the same time, there was an unprecedented spike in child and teen suicides.
The study isn't proof that the antidepressant warnings caused the increase in suicides. But the circumstantial evidence -- from both the U.S. and the Netherlands -- is very compelling, says study researcher Hendricks Brown, PhD, director of the prevention science and methodology group at the University of South Florida College of Public Health, Tampa.
"The FDA actions look like they had very serious unintended consequences," Brown tells WebMD. "Our analyses show that the FDA actions, which should have reduced or at least not changed the number of suicides for youth, had just the opposite effect."
On the advice of an expert panel, the FDA in 2004 put a "black-box" warning -- its highest warning level -- on antidepressants for pediatric use. The panel's advice was based not on actual suicides, but on indications that suicidal thoughts and behaviors increased in some children and teens taking newer SSRI-type antidepressants.
It looks as though the FDA effort backfired, says Boris Birmaher, MD, director of the child and adolescent mood and anxiety program at the University of Pittsburgh's Western Psychiatric Institute. Birmaher was not involved in the study.
"Years ago we speculated that suicides -- not suicidal thoughts or suicide attempts but real deaths -- were going down because a lot of doctors, not just psychiatrists, were prescribing SSRI antidepressants," Birmaher tells WebMD. "Then comes the black box, and without any other specific reason there was a huge increase in the number of kids dying from suicide. This is not proof, just a statistical association. But it is suspicious."
Researcher Robert D. Gibbons, PhD, of the University of Illinois, Chicago, was a member of the FDA panel. He voted against the black-box warning.
"The FDA has overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons told WebMD in April 2007.
The study by Gibbons, Brown, and colleagues, appears in the September issue of the American Journal of Psychiatry.
(Have you held off putting your teen on antidepressants because of black box warnings? Talk about it on the Depressed and Bipolar Kids: Family Support message board.)
Did FDA Teen Suicide Warning Backfire?
After Antidepressant Warning, Youth Prescriptions Down, but Suicides Way Up
Sept. 13, 2007 - Warnings that antidepressants may increase teen suicides appear to have backfired, a new study suggests.
The study shows that a steep drop in antidepressant prescriptions for children and teens followed the FDA and European drug authority warnings. At the same time, there was an unprecedented spike in child and teen suicides.
The study isn't proof that the antidepressant warnings caused the increase in suicides. But the circumstantial evidence -- from both the U.S. and the Netherlands -- is very compelling, says study researcher Hendricks Brown, PhD, director of the prevention science and methodology group at the University of South Florida College of Public Health, Tampa.
"The FDA actions look like they had very serious unintended consequences," Brown tells WebMD. "Our analyses show that the FDA actions, which should have reduced or at least not changed the number of suicides for youth, had just the opposite effect."
On the advice of an expert panel, the FDA in 2004 put a "black-box" warning -- its highest warning level -- on antidepressants for pediatric use. The panel's advice was based not on actual suicides, but on indications that suicidal thoughts and behaviors increased in some children and teens taking newer SSRI-type antidepressants.
It looks as though the FDA effort backfired, says Boris Birmaher, MD, director of the child and adolescent mood and anxiety program at the University of Pittsburgh's Western Psychiatric Institute. Birmaher was not involved in the study.
"Years ago we speculated that suicides -- not suicidal thoughts or suicide attempts but real deaths -- were going down because a lot of doctors, not just psychiatrists, were prescribing SSRI antidepressants," Birmaher tells WebMD. "Then comes the black box, and without any other specific reason there was a huge increase in the number of kids dying from suicide. This is not proof, just a statistical association. But it is suspicious."
Researcher Robert D. Gibbons, PhD, of the University of Illinois, Chicago, was a member of the FDA panel. He voted against the black-box warning.
"The FDA has overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons told WebMD in April 2007.
The study by Gibbons, Brown, and colleagues, appears in the September issue of the American Journal of Psychiatry.
(Have you held off putting your teen on antidepressants because of black box warnings? Talk about it on the Depressed and Bipolar Kids: Family Support message board.)
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