Page "Sertraline" Paragraph 34

Suicidal ideation and behavior in clinical trials are rare.

For the above analysis, the FDA combined the results of 295 trials of 11 antidepressants for psychiatric indications in order to obtain statistically significant results.

Considered separately, sertraline use in adults decreased the odds of suicidal behavior with a marginal statistical significance by 37 % or 50 % depending on the statistical technique used.

The authors of the FDA analysis note that " given the large number of comparisons made in this review, chance is a very plausible explanation for this difference ".

The more complete data submitted later by the sertraline manufacturer Pfizer indicated increased suicidal behavior.

Similarly, the analysis conducted by the UK MHRA found a 50 % increase of odds of suicide-related events, not reaching statistical significance, in the patients on sertraline as compared to the ones on placebo.