Author(s): Vanderburg DG, Batzar E, Fogel I, Kremer CM, Vanderburg DG, Batzar E, Fogel I, Kremer CM, Vanderburg DG, Batzar E, Fogel I, Kremer CM, Vanderburg DG, Batzar E, Fogel I, Kremer CM
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Abstract OBJECTIVE: The analyses were conducted to identify possibly suicide-related adverse events in Pfizer-sponsored, phases 2 through 4, placebo-controlled, completed studies of sertraline in adult patients and evaluate the risk of suicidality with sertraline versus placebo. METHOD: U.S. Food and Drug Administration (FDA)-defined search methodology was used to identify possibly suicide-related adverse events in short-term, all-duration/all-indication, and psychiatric studies of sertraline. Categorization of possibly suicide-related adverse events was based on the approach developed by the Columbia group for the FDA's analysis of pediatric suicide risk with antidepressants. The incidences of possibly suicide-related adverse events were calculated for individual classifications and for the predefined combined category of suicidality along with the sertraline versus placebo relative risks and corresponding 95\% CI limits. Exact binomial CI limits were calculated for the individual treatment group incidences. Age group analyses were also performed using the age limits defined by the FDA. RESULTS: Ninety-nine suicidality events were identified among 19,923 sertraline- and placebo-treated subjects participating in 126 studies conducted between the mid-1980s and the mid-2000s. Four cases of completed suicides among 10,917 sertraline-treated subjects yielded an incidence of 0.04\% (95\% CI = 0.01 to 0.09) and 3 cases among 9,006 placebo treated subjects yielded an incidence of 0.03\% (95\% CI = 0.01 to 0.10). There were no statistically significant differences between sertraline and placebo in any of the individual categories or combined suicidality risk category across all performed analyses. CONCLUSION: Results of short-term, all-duration, and psychiatric studies analyses, as well as age-group analyses, performed in accordance with the FDA-specified search strategy, show no significant increase in suicidality risk in adult sertraline- versus placebo-treated patients. Copyright 2009 Physicians Postgraduate Press, Inc.
This article was published in J Clin Psychiatry
and referenced in Epidemiology: Open Access