FDA Panels Back Black Box Warning on Antidepressants: Analysis of 24 Pediatric Trials Showed an Increased Suicidality Risk of 2%-3%

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BETHESDA, MD. -- A black box warning alerting prescribers to the risk of suicidal behavior and ideation with antidepressants in pediatric patients will likely be added to the labels of antidepressants, as recommended by the majority of the members of two Food and Drug Administration advisory panels.

At the end of a widely anticipated 2-day joint meeting, the FDA's psychopharmacologic drugs and pediatric advisory committees concluded that a reanalysis of the suicidality data from 23 pediatric trials of antidepressants, and a recently published trial of fluoxetine, indicated that those drugs were associated with an increased risk of suicidality--a term defined by the FDA as suicidal behavior and ideation.

An FDA analysis of 24 clinical trials determined that the increased risk over placebo was about 2%-3%, which, despite the limitations of the studies, was described as a "reasonably consistent signal for risk" by Dr. Thomas Laughren, leader of the FDA's psychiatric drug products group.

The relative risks of nine newer antidepressants in the trials--citalopram (Celexa), fluvoxamine (Luvox), paroxetine (Paxil), fluoxetine (Prozac), sertraline (Zoloft), venlafaxine (Effexor XR), mirtazapine (Remeron), nefazodone (Serzone), and bupropion (Wellbutrin)--varied, and most of the risks came from but were not limited to trials of major depressive disorder (MDD).

The panels agreed that it was better not to specify a chemical class of antidepressants, but antidepressants as a class. They also opted not to specify one disorder, since there was an increased risk detected in non-MDD trials of some of the drugs.

Panel members then voted 15-8 in favor of adding a black box warning to convey this information to prescribers. Dr. Robert …