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Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i65 (Published 27 January 2016) Cite this as: BMJ 2016;352:i65

Re: Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports

The authors ofthis paper essentially duplicate, with more limited data, many of the analyses presented in our 2009 BMJ paper but appear not to have read our paper very carefully. They write, "The FDA did not consider the limitations of the trials that we identified and introduced some of their own—for example, by only counting events within 24 hours after the randomised phase was over." Our event counts were based upon individual adverse event reports because we were concerned that the assessments by pharmaceutical sponsors may not have been accurate. Unlike the authors, we used a validate and standardized instrument to determine suicidal ideation or behavior; their determinations appear to have been more subjective. As for the 24 hour "limitation", this referred to the time of initial suicidal ideation or behavior; a subject who attempted suicide but whodid not die from the attempt until several days later would have been counted - not much of a limitation.

As for their statement that "an FDA employee published a paper in 2001 using FDA data that showed 22 suicides in 22 062 patients randomised to antidepressants,35 which equates to 10 per 10 000 population, but in the large FDA meta-analysis five years later, five suicides were reported in 52 960 patients, or 1 per 10 000 population," the "FDA employee" in question is the second author of our paper. The count of 22 suicides refers to all suicides in both placebo and treated groups and during open-label extensions and studies. The count of 5 suicides refers to antidedepressant-treated subjects only during double-blind treatment periods.

Competing interests: No competing interests

31 January 2016
Marc Stone
Physician
US FDA
10993 New Hampshire Ave Silver Spring MD 20