Martus, Hans-Joerg, Erkman, Linda, Maremanda, Nihal, Elhajouji, Azeddine and Hartmann, Andreas (2021) Comprehensive review of genotoxicity data for diclofenac. Mutation research..

Abstract

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) discovered decades ago, which has since been used by an estimated one billion patients, and demonstrated a well acceptable safety profile. In support of its marketing approval, a comprehensive set of genotoxicity studies had been conducted in vitro and in vivo. Despite the fact that these studies preceded both GLP requirements and ICH guidelines on genotoxicity testing, they were conducted using the best scientific principles and are considered appropriate by contemporary standards. In addition to bacterial mutagenicity and mammalian in vitro assays, repeat-dose, germ cell and dominant lethal assays had been conducted. These data are made available for the first time to offer researchers an opportunity to review the existing data set which unequivocally demonstrates that diclofenac is not genotoxic. The lack of a genotoxic potential is further substantiated by long-term bioassay data demonstrating that diclofenac has no carcinogenic potential in rodents. However, more recently, new studies were published showing a genotoxic potential for diclofenac in novel or modified in vitro test systems. These new data are discussed in the context of the existing comprehensive data package.

Item Type:	Article
Date Deposited:	10 Apr 2021 00:45
Last Modified:	10 Apr 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44046