Systematic Reviews
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pharmacol Ther. May 5, 2021; 12(3): 40-55
Published online May 5, 2021. doi: 10.4292/wjgpt.v12.i3.40
Overview of drug induced liver injury in Brazil: What is the role of public health policy on the evidence?
Matheus William Becker, Karin Hepp Schwambach, Michele Lunardelli, Carine Raquel Blatt
Matheus William Becker, Karin Hepp Schwambach, Michele Lunardelli, Carine Raquel Blatt, Graduate Program in Medicine-Hepatology, Federal University of Health Sciences of Porto Alegre, Porto Alegre 90050-170, RS, Brazil
Carine Raquel Blatt, Pharmacoscience Department, Federal University of Health Sciences of Porto Alegre, Porto Alegre 90050-170, RS, Brazil
Author contributions: Becker MW, Lunardelli M, and Blatt CR collected the data and wrote the paper; Becker MW, Schwambach KH, Blatt CR wrote and revised the paper.
Conflict-of-interest statement: Authors declare no conflict of interests for this article.
PRISMA 2009 Checklist statement: The guidelines of the PRISMA 2009 statement have been adopted.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Matheus William Becker, MSc, Pharmacist, Graduate Program in Medicine-Hepatology, Federal University of Health Sciences of Porto Alegre, Sarmento Leite, 245 Street, Porto Alegre 90050-170, RS, Brazil. matheuswbecker@gmail.com
Received: November 25, 2020
Peer-review started: November 25, 2020
First decision: January 7, 2021
Revised: January 20, 2021
Accepted: April 25, 2021
Article in press: April 25, 2021
Published online: May 5, 2021
ARTICLE HIGHLIGHTS
Research background

Drug-induced liver injury (DILI) is the main cause of safety-related drug marketing withdrawals and could increase costs and morbidity in the health system. DILI identification is a challenge due to the diversity of drugs with hepatotoxic potential, the lack of symptoms specificity, and the absence of specific biomarkers in the clinical practice.

Research motivation

Identify and summarize Brazilian studies reporting the drug-induced liver injury.

Research objectives

The aim of this study was to know the profile of DILI in Brazil. A systematic review of Brazilian DILI studies was carried out until June 2020. It was found 32 studies, being 10 retrospective cohorts, 12 prospective cohorts, 5 cross-sectional, 3 case-control, one case series and one randomized clinical trial. Tuberculosis, human immunodeficiency virus and hepatitis C virus patients were the mainly group investigated the hepatotoxicity rate ranged from one to 57%, led by isoniazid, rifampicin, and pyrazinamide. Few studies reported algorithm to assess causality Drug interruption and moderate outcomes are report in the most of studies. Severe outcomes, such as chronic liver damage and liver transplantation were reported in some studies.

Research methods

It was found 32 studies, being 10 retrospective cohorts, 12 prospective cohorts, 5 cross-sectional, 3 case-control, one case series and one randomized clinical trial. In most studies were investigated tuberculosis patients followed by other infectious conditions like human immunodeficiency virus (HIV) and hepatitis C virus. The hepatotoxicity ranged from one to 57%, led by isoniazid, rifampicin, and pyrazinamide. Few studies reported algorithm to assess causality. In most studies, there were moderate outcomes and it was necessary drug interruption. However, few severe outcomes, such as chronic liver damage and liver transplantation were reported.

Research results

DILI could be caused both by non-prescription drugs and by those used for chronic diseases. The diagnosis and notification of the DILI cases are of great importance for the early detection and reduction of damages to the patients.

Research conclusions

Twenty-two different criteria for hepatotoxicity were found. Standardization of parameter of drug-induced liver injury and greater effort in pharmacovigilance could contribute to learn more about DILI's epidemiology in Brazil.

Research perspectives

This research is expected to broaden the debate to establish a solid pharmacovigilance policy and the creation of a wide national DILI monitoring network and his integration with other DILI networks. Finally, bringing together experiences and cases bringing doctors, pharmacists, industry and patients closer together.