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.
Highlights
Drug-induced liver injury (DILI) is a rare but potentially severe adverse drug reaction that should be considered in patients who develop laboratory criteria for liver injury secondary to the administration of a potentially hepatotoxic drug
This study was aimed to determine the incidence and characteristics of DILI among the various adverse reactions reported to an AMC Pharmacovigilance Programme of India (PvPI) from a database over a duration of 8 years (2011–2018)
Drug-induced liver injury remains a challenge in modern hepatology
Summary
Drug-induced liver injury (DILI) is a rare but potentially severe adverse drug reaction that should be considered in patients who develop laboratory criteria for liver injury secondary to the administration of a potentially hepatotoxic drug. Incidence of DILI in the west is reported to be 14/100,000 patient-years [1,2]. Studies before the release of a drug are usually underpowered to detect rare side effects such as DILI and information on these is often obtained in the post-marketing phase. Very few studies have been done in India for the evaluation of DILI. This study was aimed to determine the incidence and characteristics of DILI among the various adverse reactions reported to an AMC Pharmacovigilance Programme of India (PvPI) from a database over a duration of 8 years (2011–2018). The results would help guide the clinicians about the causal drugs, characteristics, and management of DILI in our health-care setup
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