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SSRIs: Reconsidering Their Role in Childhood Depression
In 2003, the U.K. equivalent of the FDA (the CSM) banned the use of all selective serotonin reuptake inhibitors (SSRIs) except fluoxetine for treating depression in children and adolescents. The ban occurred because of concern about reported suicidal behavior in some children very shortly after treatment was initiated with several SSRIs. This prompted two independent groups to systematically review data from randomized controlled trials of SSRIs.
The first group reviewed two trials of fluoxetine that included 315 children (age range, 7-18 years); better responses (i.e., lower depression scores or remission) and lower rates of serious adverse events (e.g., suicidal behavior) were found in the experimental groups than in the placebo groups. Published and unpublished data on paroxetine compared with placebo revealed no clinical efficacy for paroxetine in children and increased risk for serious adverse events. In the single study of sertraline, its efficacy was superior to that of placebo; however, when additional unpublished data on remission from other trials was considered, that benefit disappeared. Citalopram and venlafaxine (a serotonin noradrenaline reuptake inhibitor) had unfavorable risk-benefit profiles.
The second group compared the collective results of six studies (including some of those discussed above) that involved 941 children who were assigned to fluoxetine, paroxetine, sertraline, or venlafaxine or to placebo. Effectiveness was found only in doctors' ratings of depression; no efficacy was shown for any of 10 measures that relied on patients' or parents' reports. Serious adverse events were significantly more common among paroxetine and sertraline recipients than among placebo recipients.
Comment: Concerns about the safety of SSRIs for children are not confined to the U.K.; the FDA also is reconsidering the role of SSRIs in treatment of childhood depression. Some people have suggested that data on serious adverse events have been minimized and those on clinical efficacy have been magnified. Clinicians who use SSRIs to treat childhood depression must recognize that SSRIs' efficacy might be limited and that serious side effects, such as suicidal behavior, can occur after treatment is initiated. If an SSRI is prescribed for a young patient, very close monitoring is necessary. At the time of publication, the full text of the second original article was available free of charge.
— Howard Bauchner, MD
Published in Journal Watch General Medicine May 11, 2004
Citation(s):
Whittington CJ et al. Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data. Lancet 2004 Apr 24; 363:1341-5.
- Medline abstract (Free)
Jureidini JN et al. Efficacy and safety of antidepressants for children and adolescents. BMJ 2004 Apr 10; 328:879-83.
- Original article (Subscription may be required)
- Medline abstract (Free)