“In this re-analysis of the FDA safety summaries, we found evi-dence that the rate of (attempted) suicide was about 2.5 times high-er in antidepressant arms relative to placebo. Our findings thus conflict with the work by Khan et al., who based their effect estimates on PEY rather than the number of patients. When haz-ards are not constant over time, PEY is inappropriate and may obscure a true adverse drug effect, since (attempted) suicide most-ly occurs shortly after treatment initiation and not during con-tinuation or maintenance phases [6, 9]. Adverse-event risk should therefore be calculated based on the number of patients exposed to treatments rather than PEY, and this is also the approach ap-plied by the FDA. Thus, when based on the number of patients randomized rather than PEY, the data presented herein suggest that antidepressants significantly increase the suicide risk in adults with major depression. Further research is required to establish whether the increased suicide risk observed in RCT generalizes to real-world practice, and we acknowledge that suicide attempts constitute just one aspect of a thorough risk-benefit evaluation.”
Read Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database, on karger, June 24, 2019.
Image credit Ian Espinosa.