ASSESSMENT OF PATTERN, CAUSALITY, SEVERITY AND PREVENTABILITY OF ADVERSE DRUG REACTIONS OF ANTIDEPRESSANT DRUGS USED IN PSYCHIATRY DEPARTMENT OF A TERTIARY CARE HOSPITAL
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Abstract
Background: Antidepressant medications are a cornerstone in the management of depressive and various anxiety disorders, significantly improving the quality of life for millions worldwide. Antidepressants are commonly prescribed for a variety of psychiatric disorders. However, their use is associated with a spectrum of adverse drug reactions (ADRs), which may impact patient compliance and therapeutic outcomes.
Objectives: To evaluate the pattern, severity, and preventability of ADRs associated with antidepressant drugs in the psychiatry department of a tertiary care hospital.
Methods: A prospective observational study was conducted over a 12-month period among patients receiving antidepressant therapy. ADRs were identified, documented, and analyzed using standard pharmacovigilance tools such as Causality Assessment Scale Naranjo’s Scale, Modified Hartwig and Siegel Severity Scale, and the Schumock and Thornton Preventability Scale.
Results: A total of 329 ADRs were reported in 122 patients. The most common antidepressants associated with ADRs were selective serotonin reuptake inhibitors (SSRIs), particularly Escitalopram and Venlafaxine. The most frequent ADRs were central nervous system effects (51.67%), followed by gastrointestinal disturbances (40.72%) and sexual dysfunction (4.25%). Causality assessment classified 97.95% of ADRs as ‘possible’, and 2.05% as ‘probable’. In terms of severity, 92% were ‘mild’ and 8% ‘moderate’. Preventability assessment indicated that 7% of ADRs were ‘ preventable’ and 93% ‘not preventable’. Conclusion: The study highlights the importance of continuous ADR monitoring, especially for antidepressant medications. Most ADRs were mild and not preventable, emphasizing the need for careful selection, monitoring, and patient education to improve drug safety.
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Dr Sarita Singh
Assistant Professor, Department of Pharmacology, Kalyan Singh Government Medical College Bulandshahr, Uttar Pradesh, India
Dr. Mangesh Kumar Tripathi
Assistant Professor, Department of Pharmacology, G.S.V.M. Medical college, Kanpur, Uttar Pradesh, India
Dr Himanshu Sharma
Associate Professor, Department of Pharmacology, G.S.V.M. Medical college, Kanpur, Uttar Pradesh, India