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CHICAGO : The risk of suicidal behaviour in children and teenagers using some of the most popular antidepressants is negligible and US authorities should consider removing mandatory health warnings from the drug packaging, according to a study released Tuesday.
The use of many newer antidepressants in the treatment of children and adolescents has been dogged by controversy for years now, with critics and several studies contending that the drugs actually triggered suicidal impulses and attempts in some vulnerable patients.
In 2004, the US Food and Drug Administration (FDA) mandated tough "black box" warnings alerting consumers to the potential deadly side effects of the drugs in younger patients.
And in 2006, the FDA published a review of 24 studies involving 4,400 children and adolescents that showed the drugs carried a twofold increased risk of suicidal behaviour, although no suicides were reported.
The furore caused some doctors to shy away from writing prescriptions for such medications for younger patients, leading some physicians and patient advocates to charge that troubled youngsters were going untreated, according to many US newspaper reports.
This study, like the FDA report in 2006, was based on a review of numerous clinical trials, but the authors analysed the data using a different methodology from the federal scientists.
The investigators found that the drug-related risk of suicidal behaviour was less than one percent, and that just one in 100 youngsters reported experiencing suicidal thoughts after beginning to take the medications.
Even fewer than one in 100 acted on those thoughts and no one killed themselves, according to the study in the April 18 edition of the Journal of the American Medical Association (JAMA).
The researchers concluded that the risk was not statistically significant, and that the drugs were effective for the treatment of anxiety disorders and to a lesser extent obsessive compulsive disorder and major depression in children and adolescents.
"We believe that the strength of evidence presented here supports the cautious and well-monitored use of antidepressant medications as one of the first-line treatment options," the authors said.
The analysis was based on 27 studies conducted between 1998 and 2006 involving more than 5,000 participants.
Patients were all aged 19 and under and were prescribed Serzone, Effexor and Remeron or one of the many SSRIs (selective serotonin reuptake inhibitors) on the market, including Prozac and Zoloft.
David Brent, professor of psychiatry at the University of Pittsburgh School of Medicine, one of the authors of the paper, noted the dangers associated with withholding treatment from emotionally and mentally troubled youngsters and urged the FDA to review its stance on the black-box warnings.
"While there is a small, increased risk of suicidal thoughts in those who use antidepressants, it would be much, much riskier to not treat these children and adolescents dealing with these disorders," he said in a statement.
"While I support the FDA's role in monitoring the safety of medications, in this case, the FDA should reconsider the black-box warning on these medications," he concluded.
The study was funded by the National Institute of Mental Health and conducted by Brent and Jeffery Bridge at Ohio State University in Columbus, Ohio. - AFP/fa
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