A prospective observational study to evaluate safety reporting of antidepressants at a tertiary care hospital in India

Indian J Pharmacol. 2014 Sep-Oct;46(5):543-6. doi: 10.4103/0253-7613.140591.

Abstract

Objective: This prospective observational study was carried out to identify the prevalence and Severity of ADRs of antidepressant in a tertiary care teaching hospital.

Materials and methods: Patients prescribed with at least one antidepressant were randomly selected and monitored for adverse drug reactions (ADRs), irrespective of their age and gender.

Results: Of the 401 patients who received antidepressants, 170 patients (42.39%) experienced 204 ADRs. Selective serotonin receptor inhibitors (SSRIs) [110 (53.92)] was the most common therapeutic class of drugs associated with ADRs. Gastrointestinal system [54 (26.47)] was most commonly affected system organ class. Dry mouth (n = 30) and diaphoresis (n = 21) were the most frequently reported ADRs. As assessed by the World Health organization (WHO) probability scale, 61% of the ADRs were 'probable' causality. Among all the ADRs, 22.54% (46) were preventable. Majority of the ADRs [(n = 184) 90.17%] were 'mild' in their severity.

Conclusion: In this study, incidence of adverse reaction to antidepressants was 42.3% were the most common SSRI inplicated drug group for the ADRs.

Keywords: Adverse effects; antidepressants; depression; psychiatric patients; psychiatry.

Publication types

  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Aged
  • Antidepressive Agents / adverse effects*
  • Child
  • Female
  • Humans
  • Incidence
  • India
  • Male
  • Middle Aged
  • Prevalence
  • Prospective Studies
  • Selective Serotonin Reuptake Inhibitors / adverse effects*
  • Severity of Illness Index
  • Tertiary Care Centers
  • Young Adult

Substances

  • Antidepressive Agents
  • Serotonin Uptake Inhibitors