AMA to Study Safety of SSRIs In Youngsters

The AMA will prepare an independent and comprehensive review of the scientific data pertaining to safety and efficacy of using selective serotonin reuptake inhibitor (SSRI) antidepressants in the treatment of child and adolescent psychiatric disorders.

In response to a resolution introduced by APA and the American Academy of Child and Adolescent Psychiatry (AACAP), the AMA's Council on Scientific Affairs will be preparing a report in an attempt to mitigate some of the confusion surrounding the Food and Drug Administration's (FDA) recent“ black box warning” about the risk of suicidality in children and adolescents being treated with SSRIs (Psychiatric News, November 19, 2004).

The resolution was approved by the AMA's House of Delegates at last month's interim meeting in Atlanta. Testimony in reference committee hearings preceding the vote was overwhelmingly supportive.

(Prior to any action taken by the House of Delegates, all resolutions are brought before a reference committee and debated; based on testimony provided during that hearing, the reference committee then makes a recommendation to the house to approve the resolution or not, with or without amendments.)

John McIntryre, M.D., chair of the AMA Section Council on Psychiatry and chair of the reference committee that heard testimony on the issue of children and SSRIs, told Psychiatric News that the FDA action had created much confusion around the use of medications that have proven successful in the treatment of some children and adolescents.

“It was clear to the House of Delegates that the FDA black-box warning was confusing both to the public and parents with kids on antidepressants, but also to physicians who prescribe these medications,” McIntyre said. “The house approved the resolution asking for a prompt study by the AMA's Council on Scientific Affairs.”

Child psychiatrist David Fassler, M.D., vice chair of the Section Council on Psychiatry, AACAP delegate, and author of the resolution, told the reference committee that the data on which the FDA based its action were far from conclusive.

“Data on children and SSRI antidepressants are inconsistent and inconclusive,” Fassler said. “In particular, it's important to underscore that there have been no actual suicides in any of the clinical trials, which have now included close to 5,000 subjects. Second, the public is confused by inaccurate and contradictory media reports. And finally, physicians are confused by the recent FDA decision to require black-box warnings on all antidepressants used in the treatment of children and adolescents with psychiatric disorders. We very much need an independent, authoritative scientific review of this topic.”

In October the FDA ordered drug companies to label all antidepressants distributed in the United States with strongly worded warnings that the medications “increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) or other psychiatric disorders.”

The FDA decision has not been without controversy. In a joint statement, APA President Michelle Riba M.D., M.S., and President-elect Steven Sharfstein M.D., said, “The American Psychiatric Association believes antidepressants save lives.... We restate our continued deep concern that a `black-box' warning on antidepressants may have a chilling effect on appropriate prescribing for patients. This would put seriously ill patients at grave risk.”

Riba and Sharfstein said that APA is “working to help mitigate such an impact by collaborating with nonpsychiatric physicians—including pediatricians and general practitioners—to help them better understand their patients' needs and properly diagnose, treat, and monitor patients” (Psychiatric News, November 5, 2004). ▪