Magazine article Clinical Psychiatry News

FDA Calls for Expanded Warnings on Antidepressants

Magazine article Clinical Psychiatry News

FDA Calls for Expanded Warnings on Antidepressants

Article excerpt

The warnings of an increased risk for suicidality in pediatric patients that appear on the labels of antidepressants should be expanded to include young adults aged 18-24 years but should include a statement saying that depression also is associated with an increased risk of suicide, according to a proposal by the Food and Drug Administration.

The FDA announced May 2 that the agency was asking manufacturers of all available antidepressants to revise the warning language on antidepressant labels, which includes the black box warning, to include a new warning about an increased risk of suicidality--suicidal behavior and thinking--during initial treatment with antidepressants to young adults. Initial treatment generally is considered to cover the first 1-2 months of treatment.

Language warning about the increased risk for suicidality in children and adolescents was added to the labels in 2005.

The proposal reflects recommendations made at a December 2006 meeting held by the FDA's Psychopharmacologic Drugs Advisory Committee. At that meeting, the panel agreed that the warning on the increased risk of suicidality associated with SSRIs and other antidepressants in children and adolescents be extended up to age 25, based on data presented by the FDA at that time.

But the revised warning also will note that the FDA's data did not show an increase in risk beyond age 24 and actually showed a decreased risk of suicidal thinking and behavior in people aged 65 years and older. The revised label also will "emphasize that depression and certain other psychiatric disorders that are treated with these drugs are themselves the most important causes of suicide," Dr. Thomas Laughren, director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research, said during the briefing.

"The important message for prescribers is that these drugs do have value across the age spectrum, but their use requires certain precautions," Dr. Laughren said. 'Any patients being treated with these drugs, whatever their age, should be monitored appropriately for worsening or unusual changes in behavior, especially early in treatment. …

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