Antidepressants double suicidality in children, says FDA
New York Jeanne Lenzer
Children and adolescents treated with antidepressants are nearly twice as likely to develop suicidality—suicidal thinking and behaviour—as similar children treated with placebo. This is the finding of a meta-analysis of 24 studies by the US Food and Drug Administration. The studies tested 4582 patients taking nine antidepressants versus placebo for major depressive disorder, obsessive-compulsive disorder, generalised anxiety disorder, attention deficit or hyperactivity disorder, and social anxiety disorder.
The FDA’s analysis, published in this month’s Archives of General Psychiatry is the final review of data that were previously analysed but not released by the FDA (2006;63:332-9). News of the secret data emerged in August 2004, and led to criticism of the FDA when it was learnt that Andrew Mosholder, an expert in the FDA’s office of drug safety, concluded that antidepressants doubled the risk of suicidality in children, but he was not allowed to publish his findings (BMJ 2004;329:307, 7 Aug). FDA advisory hearings in September 2004 led FDA officials to require “black box warnings” about the risk of increased suicidality on all antidepressants for children.