Magazine article Clinical Psychiatry News

Suicide Causality Not Part of Black Box Warning

Magazine article Clinical Psychiatry News

Suicide Causality Not Part of Black Box Warning

Article excerpt

Revised requirements for antidepressant labels that would omit references to a causal link between the drugs and suicide in children and adolescents have drawn mixed reactions from clinicians.

"I think it's good that the FDA has shied away from making a blanket statement about causality," said Adelaide Robb, M.D., medical director of inpatient psychiatry at Children's National Medical Center in Washington.

But she says the black box warning is extreme.

"I wish the black box wasn't there," she said in an interview. "I think it is overly cautious, and I think it will steer people away from [prescribing] treatment that can be very effective."

The originally proposed wording for the labeling said, "A causal role for antidepressants in inducing suicidality has been established in pediatric patients." However, before the new labeling was implemented, the Food and Drug Administration decided to soften the language.

Current wording reads, "Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. …

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