Study of adverse drug reactions of atypical antipsychotic drugs in the department of psychiatry in a tertiary care hospital of Assam

Objective: To monitor the adverse drug reactions (ADRs) of atypical antipsychotic drugs in the outpatient department (OPD) of psychiatry in Silchar Medical College and Hospital (SMCH) of Assam, and also to find out the causality and severity of ADRs, related to the antipsychotic drugs. Methodology: It was a prospective observational study carried in OPD of psychiatry. Permission from the institutional ethical committee (SMCH) was obtained. Patients with any psychotic disorder above 18 years (excluding pregnant women) of either sex who were prescribed only one atypical antipsychotic were included. Prescription containing conventional antipsychotics was excluded. ADRs reported spontaneously by the patients and also responses obtained in a questionnaire related to the likely ADRs from the patients was recorded in the case record form. Results: Total 78 patients out of whom 48 males and 30 females were included in this study. Of these, 71 patients complained of different types of problems after taking the medicines. Incidence of ADRs was higher in male (46 patients [64.78%]) in comparison to female (25 patients [35.21%]). Total 31 different types of ADRs were detected with the use of these antipsychotics. Weight gain was the most common ADR observed in 38 patients (53.52%). Out of four atypical antipsychotic drugs which have been encountered during our study causing ADRs, olanzapine was commonest followed by risperidone and amisulpride. Causality assessment using Naranjo's scale revealed that 85 (51.20%) ADRs were found to be “probable” and 81 (48.79%) were found as “possible” ADRs. According to Hartwig's severity assessment scale majority of ADRs were assessed as mild (108 [65.06%]) and 58 (34.93%) ADRs were assessed as moderate. Conclusion: Study showed weight gain was the commonest ADR with atypical antipsychotic drugs. The commonest drug causing ADRs was olanzapine. Majority of ADRs were assessed as probable as per Naranjo's scale and mild according to Hartwig's severity assessment scale.