The Food and Drug Administration (FDA) recently convened a public hearing on the safe use of antidepressants in pediatric patients and, on September 16, 2004, issued an update on its analysis of existing data. The report summarizes the FDA's recommendations based on the agency's Psychopharmacologic Drugs Advisory and Pediatric Advisory Committees' analysis of existing data, along with testimony from children and teenagers who had been helped by the medications. The agency acknowledged that the recent analysis of research trials showed a greater risk of suicidal behavior among children taking antidepressants during the first few months of treatment. The average risk for children taking the drugs was 4%, twice the placebo risk of 2%. Although no suicides occurred in these trials, the FDA has begun to require stronger warning labels for all antidepressants. However, the FDA maintains that children and adolescents should continue to have access to a full range of antidepressants and has called for more research into the matter. The specific drugs included in the analysis are:
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The FDA recommends that prescribing physicians, patients and their families be informed and watch for side effects, particularly in the early period after any of these medications are prescribed and at times of dosage changes. Adverse effects to watch for that might be linked to suicidal thinking and behavior include:
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Magellan's position, as stated in our guidelines on Major Depressive Disorder, is that the balance of evidence strongly supports the use and effectiveness of antidepressant medications in treating depression. We have encouraged our providers to continue to use their clinical judgment in treating depressed individuals and to follow the recommendations of our adopted practice guidelines. We have also recommended that our providers follow the Magellan Practice Guideline for Assessing and Managing the Suicidal Patient.
Magellan also recommends following the cautions of the earlier FDA Advisory statement, specifically that prescribing physicians, patients, and families stay alert and watchful for the above-mentioned warning signs and take prompt action if they or any other adverse affects are observed while taking these medications. If you have any questions or concerns, please talk to your provider, or contact Magellan using the toll-free number on your benefit or plan materials.
This page last updated November 14, 2008