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Page: << Prev | 1 | 2 | 3 | Next >> One year later, the FDA directed manufacturers of those drugs to revise their labeling to include a black-box warning. The warning alerts health-care providers to an increased risk of suicide and suicidal thoughts in children and teens.
On the other side of the argument, a major new study found that SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.
The negative press SSRIs received may have had a chilling effect on their use in the pediatric population, however. One recent study found that the number of U.S. children being prescribed the antidepressants has dropped since warnings about suicidal behavior associated with the drugs emerged. This trend could be worrisome if it means that young patients who might benefit from SSRIs aren't getting them, experts have said.
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The only SSRI approved by the FDA for use in pediatric patients is Prozac, but others are prescribed on an off-label basis.
In 2004, an FDA review of 24 placebo-controlled trials involving antidepressant medication in more than 4,400 children and adolescents found that the medications spurred a twofold (4 percent vs. 2 percent) increased risk for suicidal behavior or ideation (thoughts of suicide), although no completed suicides were reported.
The current paper was a large review of all of the published and unpublished randomized clinical trials involving the use of antidepressants by children and adolescents younger than 19. The youngsters were being treated for major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and anxiety disorders other than OCD. In all, 27 trials were reviewed and 5,310 patients were followed.
For every 100 children and adolescents treated with antidepressants, about one child would have thoughts of suicide or would attempt suicide beyond the risk associated with the underlying condition, the researchers found.
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