A week before the FDA’s contentious hearing on SSRIs and child and adolescent suicidal behaviors, the American College of Neuropsychopharmacology (ACNP) released a preliminary report at a Washington, D.C., press briefing concluding that popular antidepressant medications do not increase suicidal behaviors in patients under age 18 with depression.
“The evidence linking SSRIs to suicide is weak,” said J. John Mann, M.D., co-chair of the ACNP task force examining the issue and a professor of psychiatry at Columbia University College of Physicians and Surgeons. Mann is also chief of neuroscience at the New York State Psychiatric Institute.
“There are strong lines of evidence in youth—from clinical trials, epidemiology and autopsy studies—that led the ACNP task force to conclude that SSRIs do not cause suicide in youth with depression.”
The ACNP task force reviewed a subset of the clinical trial data available to the FDA (see story on
page 1)—both published and unpublished—on the use of SSRIs in children and adolescents with depression. The task force was formed last September following British regulators’ warnings to physicians in May 2003 not to prescribe SSRIs to patients under the age of 18. British regulators based their decisions on a significantly broader database than that which was available to the ACNP. The FDA issued weaker warnings in June 2003 noting the controversy and advising close monitoring of any patient under 18 taking SSRIs.
“The most likely explanation for the episodes of attempted suicide while taking SSRIs is the underlying depression, not the SSRIs,” said Graham Emslie, M.D., co-chair with Mann on the task force and chief of the division of child and adolescent psychiatry at the University of Texas Southwestern Medical Center at Dallas. “The potential benefits of SSRIs outweigh the risks.”
Mann, who has devoted the last 30 years to the study of youth suicide, noted that suicide attempts and suicidal ideation in youths with depression is common, but completed suicide is rare. Unfortunately, he said during the press briefing, the link between suicidal ideation or attempt and actual suicide completion is highly complex and not well understood. What is known is that “kids who think about it or attempt it are not the same as those who complete it. There may be a link between what I would refer to as failed suicides and completion.”
A failed suicide, he noted, is a serious attempt that would have led to the patient’s death if medical intervention had not occurred.
The ACNP task force members emphasized that the current data appear to be contradictory, and it is difficult to draw conclusions on a drug’s efficacy in pediatric depression, for example, when three clinical trials are available, with one trial showing robust efficacy, a second showing small efficacy, and the third showing no statistical difference from placebo. The differences among individual trial results, the researchers said, is likely due to differences in methodology and data reporting.
ACNP is strongly urging that all data held by pharmaceutical companies or the FDA be made available publicly so that ACNP and others can conduct complete, independent evaluations.
A copy of the executive summary of the ACNP report is posted online at www.acnp.org.
