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Healthy Skepticism Library item: 9847

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: Journal Article

FDA Reanalyzes Data as Controversy Continues Over Antidepressant Use by Children and Adolescents
Psychiatr Serv 2004 May; 55:(5):598-599


Published reports of antidepressant trials among children and adolescents have consistently exaggerated the benefits of the drugs and downplayed serious adverse effects, including suicidality, according to a meta-analysis of data from efficacy trials that was published in the British Medical Journal (BMJ) in April. The authors cited “disturbing shortcomings” in the studies’ methods and reporting and concluded that “confidently recommending these drugs as a treatment option, let alone as first line treatment, would be inappropriate.”

The data reviewed came from six placebo-controlled trials of three antidepressants-fluoxetine, sertraline, and paroxetine-among patients under age 18. The authors found that improvement in the group receiving placebo was strong and that the additional benefit from the drugs was of doubtful clinical significance, which led them to conclude that the evidence was not sufficient to justify risking the adverse effects observed in the trials…


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