Safety profile of amisulpride in short- and long-term use.

OBJECTIVE: To assess the safety of the new atypical antipsychotic drug, amisulpride, in short- and long-term use.
METHOD: Studies comparing the safety of amisulpride with that of haloperidol and risperidone, respectively, are reviewed. Safety was monitored by open adverse event reporting, the Simpson-Angus Scale, the Barnes Akathisia Scale and the Abnormal Involuntary Movement scale.
RESULTS: In short- and long-term studies, amisulpride induced significantly less EPS and akathisia than haloperidol. Safety ratings were similar to risperidone in short-term studies. In studies of chronic schizophrenia with predominant negative symptoms, amisulpride was similar to placebo. Endocrine effects were similar in amisulpride-, haloperidol- and risperidone-treated patients. Weight gain with amisulpride was significantly less than risperidone in a short-term study. No clinically important effects on haematological, hepatic or cardiac function were recorded. Data obtained in short- and long-term studies have been confirmed in extensive post-marketing surveillance data.
CONCLUSION: Amisulpride has a broad spectrum of efficacy in schizophrenia without introducing the iatrogenic consequences associated with older therapies.