FDA Cautions Doctors That Antidepressants May Pose Youth Risks
Concerned that antidepressant use may lead to suicidal behavior in children and adolescents, the U.S. Food and Drug Administration is urging doctors to proceed with caution when prescribing the medications to youngsters.
In a health advisory issued Oct. 27, the FDA cited as the source of its concern "an excess" of reports of suicidal thinking and suicide attempts in clinical studies of pediatric patients taking such drugs to treat severe depression.
Richard Lieberman, the coordinator of the suicide-prevention program for the 740,000- student Los Angeles school district, applauded the federal warning.
"I think it's prudent—we need to back the truck up," the school psychologist said. "I don't know that there's been enough study on the use of these drugs on children."
In 20 placebo-controlled trials overseen by the FDA for eight antidepressant drugs, involving more than 4,100 pediatric patients, there were no reports of completed suicides. The data did, however, suggest more suicidal behavior and thinking among patients who were assigned to several of the antidepressants, compared with those who were given placebos, according to the FDA advisory.
Though the evidence is far from conclusive, the agency warned that "it is not possible at this point to rule out an increased risk of these adverse events for any of these drugs" when children with severe depression take them.
The drugs studied in the trials were: citalopram, fluoxetine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine. Fluvoxamine was also included, though it is not approved for use as an antidepressant in this country.
Of the eight medications, Prozac, the brand name for fluoxetine, is the only one the FDA has approved for use by children and adolescents with depression.
'Difficult Task Ahead'
The advisory last week is not the FDA's first on pediatric use of antidepressants. Last summer, the agency warned against prescribing Paxil, the brand name for the drug paroxetine, for children and adolescents because three controlled studies of pediatric patients using the drug showed "possible increased risk of suicidal thinking and suicide attempts."
Clinical studies had failed to show that Paxil was even effective in treating children who suffered severe depression, the agency noted in a June 19 warning. The FDA never approved Paxil for use on pediatric patients.
School health experts said last week they hoped the federal advisory would prompt greater communication between the doctors who prescribe antidepressants to children and school health officials. And some said they hoped parents would be more assertive about asking prescribing physicians whether a drug is even approved for use on younger patients.
"The decision of whether to put a student on an antidepressant is best made by a team that includes the parents, the school-health personnel, and the prescribing physician," said Scott Poland, the director of psychological services for the 75,000-student Cypress-Fairbanks school district in Houston.
Several mental- health experts said it was important to note the cautious tone of the FDA advisory.
The agency "is not saying they have proof that antidepressants cause children to commit suicide," said Stephen E. Brock, an assistant professor of psychology at the California State University-Sacramento. "What we should all do is continue to be vigilant in watching for suicidal behavior and ideation in individuals who suffer from major depressive disorder."
In a paper posted on its Web site, the FDA cautions that recent press and medical- journal reports of suicides and attempted suicides by youngsters on antidepressants "are very difficult to interpret, in the absence of a control group," because the same behavior is seen in children with major depressive disorders who are not treated with such drugs.
"The FDA has a difficult task ahead of it," Mr. Brock said. "What needs to be sorted out is, 'Is it the depression causing the suicidal behavior or is it the drug?'"
Vol. 23, Issue 10, Page 13Published in Print: November 5, 2003, as FDA Cautions Doctors That Antidepressants May Pose Youth Risks