AN ANALYSIS OF CASES OF DRUG-INDUCED LIVER INJURY REPORTED TO AN ADVERSE DRUG REACTION MONITORING CENTER

  • BALA SUBRAMANIAM Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
  • MEGHA SHAH Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
  • CHETNA DESAI Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
  • JIGAR PANCHAL Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
  • SAMIDH SHAH Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.

Abstract

Objectives: Drug-induced liver injury (DILI) is a frequent cause of liver injury and acute liver failure .We aimed to analyze the cases of DILI reported over a period of 8 years to the adverse drug reaction (ADR) monitoring center (AMC) at our institution.


Methods: This observational retrospective study was conducted at the ADR monitoring center of a tertiary care hospital. Cases reported to the AMC, Pharmacovigilance Programme of India during the year 2011–2018 were analyzed as per the criteria used to analyze the ADRs.


Results: A total of 5448 ADRs were reported during the study period, of which 105 (2%) were suspected to be DILI. The mean age of the patients with DILI was 39.26 years. Men (66.66%) were more commonly affected than women (33.34%). The most common drug groups causing DILI were antiretroviral (ART) (42.85%) and antitubercular (ATT) (40%). Most common single drug responsible for DILI was isoniazid (44.44%) followed by atazanavir (28%) and pyrazinamide (22.22%). Increase in serum bilirubin was the most common DILI (64.75%). About 79% of cases had a possible causality and 21% of cases had probable causal association with the suspected drugs. Majority of the ADRs (83%) were not preventable and mild in severity (21%). All ADR forms were complete in accordance with National Coordinating Center scale.


Conclusion: DILI is commonly observed in patients taking ART and ATT drugs for more than a month. Regular monitoring and assessment in these patients may help in preventing DILI and manage these ADRs.

Keywords: Drug-induced liver injury, Hepatotoxicity, Adverse drug reaction, AMC, Pharmacovigilance Programme of India

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SUBRAMANIAM, B., M. SHAH, C. DESAI, J. PANCHAL, and S. SHAH. “AN ANALYSIS OF CASES OF DRUG-INDUCED LIVER INJURY REPORTED TO AN ADVERSE DRUG REACTION MONITORING CENTER”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 11, Sept. 2020, pp. 109-12, doi:10.22159/ajpcr.2020.v13i11.39312.
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