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

BALA SUBRAMANIAM; MEGHA SHAH; CHETNA DESAI; JIGAR PANCHAL; SAMIDH SHAH

doi:10.22159/ajpcr.2020.v13i11.39312

Authors

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.

DOI:

https://doi.org/10.22159/ajpcr.2020.v13i11.39312

Keywords:

Drug-induced liver injury, Hepatotoxicity, Adverse drug reaction, AMC, Pharmacovigilance Programme of 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.

Downloads

Download data is not yet available.

References

Sgro C, Clinard F, Ouazir K, Chanay H, Allard C, Guilleminet C, et al. Incidence of drug-induced hepatic injuries: A French population based study. Hepatology 2002;36:451-5.

Shapiro MA, Lewis JH. Causality assessment of drug induced hepatotoxicity: Promises and pitfalls. Clin Liver Dis 2007;11:477.

Holt M, Ju C. Drug induced liver injury. Handb Exp Pharmacol 2010;196:3-27.

Larrey D. Epidemiology and individual susceptibility to adverse drug reactions affecting the liver. Semin Liver Dis 2002;22:145.

Kullak-Ublick GA, Andrade RJ, Merz M, End P, Benesic A, Benesic A, et al. Drug-induced liver injury: Recent advances in diagnosis and risk assessment. Gut 2017;66:1154-64.

Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L. Drug safety discontinuations in the United States, and Spain from 1974-through 1993: A regulatory perspective. Clin Pharm Ther 1995;58:108-17.

Naranjo CA, Busto U, Sellars EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538.

Mahajan MM, Thatte UM, Gogtay NJ, Deshpande S. An analysis of completeness and quality of ADR reports at an adverse drug reaction monitoring centre in Western India. Perspect Clin Res 2018;9:123-6.

Alfred. Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 13th ed. United States: McGraw-Hill Education; 2018. p. 1073-140.

Andrade RJ, Lucena MI, Fernandez MC, Pelaez G, Pachkoria K, García-Ruiz E, et al. Drug induced liver injury: An analysis of 461 incidences submitted to the Spanish registry over a 10 year period. Gastroenterology 2018;17:795-804.

Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, et al. Features and outcomes of 899 patients with drug induced liver injury: The DILIN prospective study. Gastroenterology 2015;148:1340-52.

De Valle MB, Klinteberg VA, Alem N, Olsson R, Bjornsson E. Drug-induced liver injury in a Swedish university hospital out-patient hepatology clinic. Aliment Pharmacol Ther 2006;24:1187-95.

Hussaini SH, Farrington EA. Idiosyncratic drug induced liver injury: An overview. Expert Opin Drug Saf 2007;6:673-84.

Andrade RJ, Lucena MI, Kaplowitz N, Garcia-Munoz B, Borraz Y, Pachkoria K, et al. Outcome of acute idiosyncratic drug-induced liver injury: Long-term follow up in a hepatotoxicity registry. Hepatology 2006;44:1581-88.