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.
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