Are antidepressants safe for adolescents?

• Published in: Postgraduate medicine Vol. 118; no. 3; pp. 33 - 34
• Main Author: Winters, Nancy C.
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01-09-2005; JTE Multimedia
• Subjects: Adolescent; Antidepressive Agents - adverse effects; Antidepressive Agents - therapeutic use; Child; Depressive Disorder - drug therapy; Humans; Mianserin - adverse effects; Mianserin - analogs & derivatives; Mianserin - therapeutic use; Safety; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Suicide
• ISSN: 0032-5481; 1941-9260
• DOI: 10.3810/pgm.2005.09.1784

A: The October 2004 US Food and Drug Administration (FDA) mandate that a black box warning be added to labeling of all antidepressants used in children and adolescents sparked widespread concern about their use.1 (Reference) The FDA's decision was based on a review of pooled analyses of nine antidepressants (ie, selective serotonin reuptake inhibitors [SSRIs] and others) used in 24 short-term (4-week to 16-week) placebo-controlled trials.2 (Reference) As a whole, the trials had involved more than 4,400 children and adolescents with major depression, obsessive-compulsive disorder, or other disorders. The analysis revealed an average risk of suicidal thinking or behavior of 4%, twice the risk of placebo of 2%. The FDA concluded that only fluoxetine hydrochloride showed significant advantage over placebo and, therefore, the benefit of this drug exceeded the risk. Although there have been trials supporting the efficacy of citalopram hydrobromide, sertraline hydrochloride, and paroxetine, only fluoxetine has met the efficacy standard of showing benefit in at least two randomized controlled trials. A third randomized controlled trial3 (Reference) confirmed that fluoxetine, alone or in conjunction with cognitive behavior therapy, is an effective treatment for depression. In this multisite study, 61% of the subjects responded to fluoxetine alone, and 71% responded to fluoxetine plus therapy--twice the response rate of 35% for subjects who received placebo. The American Academy of Child and Adolescent Psychiatry (AACAP) and the American Psychiatric Association also recommend fluoxetine as the first-line antidepressant.4 (Reference)