Publication:

A cross-sectional study to assess the adverse effect profile of second generation antipsychotics: risperidone, olanzapine and quetiapine

Background Pharmacovigilance is the scientific approach to a drug related problem.  Psychotropic drugs are known to cause several adverse drug reactions (ADRs).  This study aimed to assess the adverse effect profile of 3 second generation antipsychotics-risperidone, olanzapine and quetiapine in patients on monotherapy of any of these second generation antipsychotics.

Methods This was a hospital based cross-sectional study conducted in psychiatric outpatient department of Psychiatry in Father Muller Mental Health Centre, Mangalore. The study sample consisted of patients suffering from schizophrenia and other psychotic disorders according to ICD 10 criteria (F20- F29) and who were maintaining remission  on any one of the second generation antipsychotics viz risperidone, olanzapine or quetiapine.

Results Out of 154 subjects, 68 were on risperidone, 74 were on olanzapine, and 12 were on quetiapine. Most common ADRs reported were increased appetite (26%), weight gain (15%), tremors (14%), fatigue (14%), constipation (14%), dyspepsia (10%), somnolence (12%), decreased appetite (10%). Among these ADRs none of them were preventable and belonged to mild to moderate severity. Causality of adverse events was assessed by Naranjo algorithm; a probability scale for ADR. Severity was assessed by modified Hartwig and Seigel scale. Preventability was assessed using Schumock and Thronton criteria.

Conclusions The most common ADRSs reported with SGAs were increased appetite and weight gain and the frequency of ADRs were higher with subjects receiving risperidone.