THE CONCEPTS AND PROSPECTS OF NIMESULIDE INDUCED HEPATOTOXICITY

Abstract

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most widely prescribed class of drug. The current study was
carried out to reveal the facts and prospects of Nimesulide, an over-the-counter NSAID drug. Around 57 cases of
hepatotoxicity collected from the DILI registry in Spain and Latin America were reviewed. Various causality cases were
assessed using the RUCAM scale, which revealed the mean age of 59 years of patients among the entire case series of
hepatotoxicity, out of which 86% were women, and the mean onset time of action was 40 days, while 46 patients, i.e.,
81%, were also suffering from jaundice. Nimesulide-induced liver injury was found to be hepatocellular in 38 cases
(67%), mixed type in 12 cases (21%), and cholestasis in 7 cases (12%). The reported incidence of NSAID-induced liver
disease in clinical trials was found to be fairly constant, ranging from 0.29 per 100,000 [95% confidence interval (CI):
0.17-051] to 9 per 100,000 (95% CI: 6-15). Therefore, a higher risk of liver-related hospitalisation (32.3 per 100,000
patients) was reported. The studies indicated that Nimesulide and other NSAIDs cause extensive liver damage, ranging
from asymptomatic transient hyperaminotransducers to fulminant liver failure. However, various shortcomings in
epidemiologic studies jeopardise the opportunity to determine the actual risk of hepatotoxicity. The drugs, such as
Benoxaprofen and Bromfenac, have been withdrawn from the market due to their hepatotoxic behaviour. The present
review was carried out to critically analyse the results currently available in the literature on NSAID-induced
hepatotoxicity and to create an overview of the most commonly used compounds of the NSAID groups.