OBJECTIVES

Liver being the primary site of metabolism plays a vital role in determining the safety profile of a drug. Liver Abnormalities perpetuates an alteration in the pharmacokinetics and pharmacodynamics of the drug, further increasing the risk of Adverse Drug Reactions (ADRs). So,this study aimed to assess the incidence of Adverse Drug Reactions observed in patients with hepatic diseases in the Gastroenterology department of a tertiary care hospital.

METHODS

A hospital based prospective and observational study was conducted among the inpatients admitted to Gastroenterology wards of a tertiary care hospital over a period of six months. The suspected ADRs observed were documented and categorized based on its causality, severity, preventability, predictability and outcomes.

RESULTS : A total of 200 patients were recruited for the study out of which 86 (43%) patients suffered with at least one ADR. ADRs were predominant in males (63%) as compared to females (37%). Patients with history of alcohol (22%) intake had higher incidence of ADRs. Majority of the ADRs were observed with Atorvastatin (11.6%), levofloxacin (11.6%) and spironolactone (10.3%). The organ system most commonly affected was gastrointestinal system (57%) followed by renal system (23%). Severity assessment showed that 22.58% ADRs were Level 2 (moderate) reactions. The preventability assessment using Schumack and Thornton scale revealed that 35 (39%) ADRs were probably preventable.

CONCLUSIONS : Early detection and management of ADRs helps to avoid further progression of the reaction and its complications. Special attention should be provided to the patients who are at a higher risk of developing ADRs.