Panel: SSRIs don't increase teen suicide risk

A report calls for the Food and Drug Administration to release all data on the use of these drugs for treating depression in young people.

By Susan J. Landers — Posted Feb. 9, 2004

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Washington -- Jumping into the debate over the pros and cons of prescribing a popular group of antidepressants to children and adolescents, an American College of Neuropsychopharmacology task force concluded that selective serotonin reuptake inhibitors do not increase teens' risk of suicidal thinking or suicide attempts and are effective in treating depression in this population.

The group's preliminary report runs counter to advisories issued last year by the U.S. Food and Drug Administration and its counterpart in the United Kingdom, which cautioned physicians about prescribing the antidepressants for children younger than 18.

The government agencies were acting on reports of a possible increase in suicidal thinking and suicide attempts among children and adolescents who were treated with certain of the SSRIs.

"At the heart of the issue is the fundamental medical principle 'do no harm,' " said J. John Mann, MD, co-chair of the ACNP panel that produced the report and a professor of psychiatry at Columbia University in New York City. Dr. Mann spoke at a Jan. 21 press briefing. "The question is, in treating these kids for depression -- which we must do -- can we do that in a way that does them more good than harm?"

That question has drawn a complicated set of responses. Britain, for example, had warned physicians against prescribing any SSRI antidepressant drug except fluoxetine (Prozac), for depressed youth younger than 18, while the FDA warned against the use of one SSRI, paroxetine (Paxil), but stopped short of warning against the use of other SSRIs. The U.S. agency has approved Prozac for treating children with depression, and its review of three trials determined that Paxil was no more effective than a placebo in treating depressed children and teens.

The FDA expanded its advisory last fall and urged physicians to monitor children and adolescents in general for changes in their clinical state and for increased suicide risk -- a step consistent with the ACNP report recommendations -- until additional evidence is examined. At press time, the agency had scheduled a Feb. 2 meeting of two advisory committees on the issue.

Differing opinions

"The most likely explanation for the episodes of attempted suicide while taking SSRIs is the underlying depression," said Graham Emslie, MD, ACNP task force co-chair and a professor of psychiatry at the University of Texas Southwestern Medical Center at Dallas.

Suicide is the third leading cause of death among young people, said Dr. Mann, and depression and other psychiatric disorders are major causes of suicide.

The task force determined that SSRIs are the only antidepressant drugs effective in treating depression in children and adolescents. If anything, the panel concluded, the increased use of SSRIs appears to have lowered the risk of suicide worldwide based on a review of epidemiological studies from several countries. The group noted that the rate of youth suicide in 15 countries had declined by about 33% over the past 15 years, a period of time that coincides with increases in SSRI prescribing rates.

Tricyclic antidepressants were not effective for young people, said the report, and cognitive behavioral therapy has not been well-tested in depressed adolescents and is not available in all parts of the country.

While the ACNP task force reached its conclusion after examining some of the same evidence that was reviewed by the FDA, it acknowledged that it did not have access to some of the studies reviewed by the FDA and recommended that all data held by the FDA or pharmaceutical companies be made available for review.

The task force of 10 -- nearly all psychiatrists -- reviewed clinical trials involving more than 2,000 young people in finding that there were no statistically significant increases in suicide attempts, self-harm and suicidal thinking related to SSRI use. In addition, there were no suicide deaths in any of the trials, said the panel.

While the task force report was not funded with pharmaceutical company money, the co-chairs and most panelists listed ties to the industry in the report. Some served as consultants and others received research funds from pharmaceutical companies.

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Treatment tools

A preliminary report by a task force of the American College of Neuropsychopharmacology includes the following recommendations for improving the treatment of children and teens with depression:

  • Continued use of selective serotonin reuptake inhibitors and other new-generation antidepressants. Clinicians should ask depressed patients about suicide, suicidal thinking and plans for suicide.
  • Release by the Food and Drug Administration of all data held by the agency or pharmaceutical companies to allow the ACNP and other research organizations to conduct an independent evaluation of the risks and benefits of SSRIs in youth and adults with depression and other mood disorders.
  • Finding better measures and assessment procedures for evaluating suicidal behavior in clinical trials.

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External links

Food and Drug Administration statement on Paxil for children (link)

American College of Neuropsychopharmacology (link)

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