The Food and Drug Administration's Deliberations on Antidepressant Use in Pediatric Patients
July 10, 2005 09:01

On February 2, 2004, the Food and Drug Administration organized a joint meeting of the Neuro-Psychopharmacologic Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to examine the occurrence of suicidality in clinical trials that investigate the use of the newer antidepressant drugs in pediatric patients. Committee members reconvened on September 13- 14, 2004, and concluded that there was a causal link between the newer antidepressants and pediatric suicidality. This article provides a summary of the Food and Drug Administration deliberations for the pediatric clinician. We also provide research, regulation, education, and practice implications for care for children and adolescents who may be eligible for treatment with these medications. Pediatrics 2005;116:195-204; depression, pediatrics, children, adolescents, antidepressants, suicide, regulation, mental health, FDA.

Last, 3 events in winter 2004-2005 that have implications for ongoing medical education included (1) announcements of previously unreported adverse effects with other psychotropic medications including atomoxetine (Strattera) and mixed amphetamine salts (Adderall), (2) the recent publication of several contrasting large- scale studies that examined the association between suicide attempts and the SSRIs in adults,40,41,67 and (3) another recently published observational study that found no association between suicide attempts and the SSRIs in pediatric patients.68 These events highlight that medical knowledge regarding medications is not static. We need to remind the medical community, health plan administrators, and the public that treatment recommendations and practice standards must continue to be reexamined and updated to incorporate new knowledge as it becomes available.

The FDA Commission hearings on the use of antidepressants in youths raised a number of important issues regarding the safety and the efficacy of the SSRIs and related antidepressant medications. Furthermore, the investigation brought attention to the needed areas of improvement in our current system for drug approval and postmarketing surveillance in pediatric as well as adult populations. It will require strong advocacy, greater oversight, and cross-organizational partnerships between clinicians, professional organizations, federal agencies, health plans, and consumers to ensure the provision of safe and efficacious treatments for children and adolescents with mental health needs.

On February 2, 2004, the Food and Drug Administration organized a joint meeting of the Neuro-Psychopharmacologic Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to examine the occurrence of suicidality in clinical trials that investigate the use of the newer antidepressant drugs in pediatric patients. Committee members reconvened on September 13- 14, 2004, and concluded that there was a causal link between the newer antidepressants and pediatric suicidality. This article provides a summary of the Food and Drug Administration deliberations for the pediatric clinician. We also provide research, regulation, education, and practice implications for care for children and adolescents who may be eligible for treatment with these medications. Pediatrics 2005;116:195-204; depression, pediatrics, children, adolescents, antidepressants, suicide, regulation, mental health, FDA.

Recent estimates of the rates of mental health disorders in pediatric populations are staggering, suggesting that at least 1 in 10 children and adolescents has mental illness severe enough to cause some level of impairment.1-5 Taken in the aggregate, mental health disorders are the most common pediatric disorders that negatively affect quality of life across the domains of home, school, and peer functioning. Many youths with these disorders go on to display an inability to function fully as adults, costing society in terms of both human and fiscal resources.