2004N-0330 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee
FDA Comment Number : EC48
Submitter : Dr. David Margulies Date & Time: 10/05/2004 04:10:30
Organization : State University of New York at Stony Brook
Health Professional
Category :
Issue Areas/Comments
A black box on the use of SSRIs, or other antidepressants, in children and/or adolescents will effectively eliminate what frequently is the only pharmacological treatment (or any treatment for that matter) available for many patients. My understanding of the research that is the basis for the consideration of a black box warning on this class of drugs is weak at best. Considering the morbidity and mortality associated with depression, and other diagnoses treated with theswe drugs, it is much more likely that restrictions will do more harm than good.