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
Abstract
BACKGROUND

Adverse drug reactions are responsible for increased costs and morbidity in the health system. Hepatotoxicity can be induced both by non-prescription drugs and by those used for chronic diseases. It is the main cause of safety-related drug marketing withdrawals and could be responsible for irreversible and fatal injuries.

AIM

To identify and to summarize Brazilian studies reporting the drug-induced liver injury.

METHODS

A systematic review of Brazilian 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. 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.

RESULTS

Twenty-two different criteria for hepatotoxicity were found. The great heterogeneity did not allow a meta-analysis. Standardization of parameter of drug-induced liver injury and greater effort in pharmacovigilance could contribute to learn more about drug-induced liver injury (DILI)’s epidemiology in Brazil.

CONCLUSION

The development of strategic public health policies seems to have an influence on the DILI scientific evidence in Brazil due to main studies are in HIV and tuberculosis line care, two strategic health policies in Brazil.

Keywords: Chemical and drug-induced liver injury, Pharmacovigilance, Pharmacoepidemiology, Adverse effects, Infectious disease medicine, Hepatotoxicity

Core Tip: Hepatotoxicity is the main cause of safety-related drug marketing withdrawals and could be responsible for irreversible and fatal injuries. A systematic review of Brazilian studies was found 32 studies and the hepatotoxicity ranged from one to 57%, led by isoniazid, rifampicin, and pyrazinamide. Few studies reported algorithm to assess causality and 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 drug-induced liver injury’s epidemiology in Brazil.