Early post-marketing phase vigilance (EPPV) of paliperidone palmitate (PAL-P) revealed a mortality of at least 32 (0.29%) out of approximately 11,000 patients with schizophrenia administered PAL-P between November 2013 and May 2014 (average administration period of four months). Since then, many psychiatrists may have become distrustful of PAL-P, as well as of other long-acting injectable antipsychotics (LAI). This study reviewed the mortality data observed in several premarketing clinical trials of antipsychotics, including PAL-P, post-marketing surveillances (PMS) of antipsychotics conducted in Japan, and several large-scale cohort studies performed in developed countries, and re-evaluated the mortality risk of PAL-P. The results of the literature review were as follows: 1) the mortality of the patients on LAI in clinical trials was 3.56-7.95/1,000 person-years. This number was not higher than that of those on oral antipsychotics (5.00-8.55/1,000 person-years); 2) the mortality of those on PAL-P in clinical trials (3.56/1,000 person-years) was not higher than that on the other LAIs (6.34-7.95/1,000 person-years); 3) the mortality of those on PAL-P observed in the EPPV(equivalent to 0.22% per three months)was similar to the three-month mortality observed in the PMSs of risperidone LAI, oral paliperidone, or oral blonanserin (0.19-0.31%); and 4) based on data of the cohort studies, the four-month mortality of those with schizophrenia was estimated at 0.35-0.68%. Therefore, the mortality observed in the EPPV of PAL-P did not seem to be of clinical significance, even allowing for the possibility of underestimating the mortality in the EPPV.
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