Objective: To assess the safety of the new atypical antipsychotic drug, ami
sulpride, in short- and long-term use.
Method: Studies comparing the safety of amisulpride with that of haloperido
l and risperidone, respectively, are reviewed. Safety was monitored by open
adverse event reporting, the Simpson-Angus Scale, the Barnes Akathisia Sca
le 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 ri
speridone in short-term studies. In studies of chronic schizophrenia with p
redominant 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 risperi
done in a short-term study. No clinically important effects on haematologic
al, hepatic or cardiac function were recorded. Data obtained in short- and
long-term studies have been confirmed in extensive post-marketing surveilla
nce data.
Conclusion: Amisulpride has a broad spectrum of efficacy in schizophrenia w
ithout introducing the iatrogenic consequences associated with older therap
ies.