What are the 2004 FDA warnings and recommendations for children and adolescents taking SSRIs for major depressive disorder (clinical depression)?

Updated: Mar 28, 2019
  • Author: Jerry L Halverson, MD; Chief Editor: David Bienenfeld, MD  more...
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Answer

In September 2004, the results of an FDA analysis suggested that the risk of emergent suicidality in children and adolescents taking SSRIs was real. The FDA advisors (Columbia University) recommended the following:

  • A black-box warning label should be placed on all antidepressants, indicating that they increase the risk of suicidal thinking and behavior (suicidality)

  • A patient information sheet (“Medication Guide”) should be provided to the patient and the patient’s caregiver with every prescription

  • The results of controlled pediatric trials of depression should be included in the labeling for antidepressant drugs

The Psychopharmacologic Drugs and Pediatric Advisory Committees recommended that the products not be contraindicated, because access was important for those who could benefit from them. For more information, see the FDAStatementonRecommendations of thePsychopharmacologicDrugsand Pediatric AdvisoryCommittees.


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