Hepatotoxicity reports in the FDA adverse event reporting system database: A comparison of drugs that cause injury
10.1016/j.apsb.2021.05.028
- Author:
Payal RANA
1
;
Michael D ALEO
1
;
Xuerong WEN
2
;
Stephen KOGUT
2
Author Information
1. Drug Safety Research & Development, Pfizer, Groton, CT 06340, USA.
2. University of Rhode Island, College of Pharmacy, Kingston, RI 02881, USA.
- Publication Type:Journal Article
- Keywords:
AE, adverse event;
Adverse event reporting;
CI, confidence interval;
CNS, center nervous system;
DILI, drug-induced liver injury;
DNA, deoxyribonucleic acid;
Drug-induced liver injury;
FAERS database;
FAERS, FDA's Adverse Event Reporting System;
FDA, US Food and Drug Administration;
Hepatotoxicity;
MedDRA, Medical Dictionary for Regulatory Activities;
Mitochondrial toxicity;
NCTR-LTKB, National Center for Toxicological Research-Liver Toxicity Knowledge Base;
NSAID, nonsteroidal anti-inflammatory drugs;
ROR, Reporting Odds Ratio
- From:
Acta Pharmaceutica Sinica B
2021;11(12):3857-3868
- CountryChina
- Language:English
-
Abstract:
Drug-induced liver injury (DILI) is a leading reason for preclinical safety attrition and post-market drug withdrawals. Drug-induced mitochondrial toxicity has been shown to play an essential role in various forms of DILI, especially in idiosyncratic liver injury. This study examined liver injury reports submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) for drugs associated with hepatotoxicity
