Nimesulide: clinical and histological evidences of severe hepatotoxicity

Bessone, Fernando; Colombato, Luis; Passamonti, Marco; J, Ferrer; Godoy, Adriana; Bagnulo, H.; Grignola, Juan C.; Rondán, Mariella; Villamil, Facundo; Guma, Carlos; Gierer, Ileana María; Vorobioff, Julio; Domínguez, N.; Fassio, E; Tanno, Hugo

doi:10.1016/s0168-8278(01)81028-x

Cited by 7 publications

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“…In a study done at Argentina to evaluate the hepatotoxic potential of nimesulide, patients had presented with jaundice, pruritus and asthenia and all patients had evidence of drug induced acute hepatitis with predominant cholestasis and one patient had hepatocellular damage. 7 But median time of onset of symptoms were 25 days and 50% of cases normalised their liver function tests in a median of 55 days. 7 In contrast to this, only hypoalbuminemia and SGPT elevation was seen.…”

Section: Discussionmentioning

confidence: 93%

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A clinical study on nimesulide hepatotoxicity

Nair

Rema²,

Shenoy³

2018

Int J Res Med Sci

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Background: Hepatic injury can occur with the use of nimesulide, a non steroidal anti-inflammatory drug. This study was done to evaluate the hepatic and renal functions in patients with rheumatological complaints receiving nimesulide for 2 weeks.Methods: Fifty patients with rheumatological complaints treated at orthopaedic outpatient clinic of a tertiary care centre with nimesulide 100mg twice daily were enrolled in this study. The sociodemographic details, details of comorbidities, history of use of alcohol or tobacco, indication for treatment with nimesulide etc. were recorded in a predesigned proforma. All patients were followed up for two weeks and reviewed at the end of each week for any gastrointestinal adverse effects, changes in blood routine, liver function tests and renal function tests. Data collected was entered in Microsoft Excel 2010, analysed and results were expressed as mean and standard deviation.Results: Out of the fifty patients analysed, mean age was 39 years. 66 % were males. Among liver function tests, only serum albumin and serum aspartate aminotransferase (SGPT) were altered after treatment with nimesulide. Blood urea nitrogen, serum creatinine and blood routine remained normal. No gastrointestinal adverse effects were noted.Conclusions: Nimesulide produced changes in serum albumin and SGPT levels without prominent gastrointestinal or renal adverse effects.

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Section: Discussionmentioning

confidence: 93%

“…7 But median time of onset of symptoms were 25 days and 50% of cases normalised their liver function tests in a median of 55 days. 7 In contrast to this, only hypoalbuminemia and SGPT elevation was seen. This may be because of lesser exposure to nimesulide in present study (only for 2 weeks).…”

Section: Discussionmentioning

confidence: 93%

A clinical study on nimesulide hepatotoxicity

Nair

Rema²,

Shenoy³

2018

Int J Res Med Sci

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“…In 1997, as per the literature, one of the groups in Argentina reported the first observation linking Nimesulide and hepatotoxicity [19]. Since then, there have been consistent reports of severe hepatotoxicity until the national health authorities of several countries withdrew Nimesulide from the market [20][21]. Nevertheless, the drug is still marketed in several European countries, but the EMEA report recommends limiting the duration of treatment to 15 days and limiting the drug use, i.e., the maximum dose, to 100 mg per day [3].…”

Section: Nimesulidementioning

confidence: 98%

“…There are several other alternatives available in market. [16]With respect to Indian marketNimeulide is not only the drug causing liver toxicity, infect several studies have indicated other drugs higher incidence as compared to Nimesulide (Table 1) [17].…”

Section: Epidemilogymentioning

confidence: 99%

The Concepts and Prospects of Nimesulide Induced Hepatotoxicity

Renuka,

Kaustubh,

Anshu

et al. 2023

JASR

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Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most widely prescribed class of drug. The current study wascarried out to reveal the facts and prospects of Nimesulide, an over-the-counter NSAID drug. Around 57 cases ofhepatotoxicity collected from the DILI registry in Spain and Latin America were reviewed. Various causality cases wereassessed using the RUCAM scale, which revealed the mean age of 59 years of patients among the entire case series ofhepatotoxicity, 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 liverdisease 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 100,000patients) was reported. The studies indicated that Nimesulide and other NSAIDs cause extensive liver damage, rangingfrom asymptomatic transient hyperaminotransducers to fulminant liver failure. However, various shortcomings inepidemiologic studies jeopardise the opportunity to determine the actual risk of hepatotoxicity. The drugs, such asBenoxaprofen and Bromfenac, have been withdrawn from the market due to their hepatotoxic behaviour. The presentreview was carried out to critically analyse the results currently available in the literature on NSAID-inducedhepatotoxicity and to create an overview of the most commonly used compounds of the NSAID groups.

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“…The most interesting point is that a self-decided [i.e., non-iatrogenic] new intake of nimesulide resulted in reappearance of pruritus 4 days later, confirmed in its nature by the increase in alkaline phosphatase, GGT and ALT, shaping an involuntary drug rechallenge. On 2001, mainly due to referrals after our initial communication in 1997, our database totalized 30 cases, out of which 17 % had severe liver injury or fulminant hepatic failure [84]. In 2009, which is to say 23 years after nimesulide was marketed in Argentina, our series includes 43 documented cases [unpublished data] of nimesulide-inducedhepatotoxicity.…”

Section: Clinical Characteristics Of Nimesulide and Nsaids Hepatotoximentioning

confidence: 99%

The Spectrum of Nimesulide-Induced-Hepatotoxicity. An Overview

Bessone¹,

Colombato²,

Fassio³

et al. 2010

AIAAMC

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Nimesulide is the unique molecule of the sulphonanilides class of non-steroidal antiinflammatory drugs [NSAIDs]: Nimesulide has analgesic, anti-pyretic, potent anti-inflammatory activities and very good gastro-intestinal [GI] tolerability. Therapeutic action is multifactorial, including cyclooxigenase-2 (COX-2) inhibition, scavenging of free radicals and inhibition of various pathways of inflammation. Nimesulide is oxidatively metabolised via liver cytochromes P450. Several unproven hepatotoxicy-predisposing-factors thought to be present in rheumatologic patients have been linked to a higher incidence of hepatic reactions in this sub-population. However, the molecular mechanism underlying hepatotoxicy remains to be elucidated. Nimesulide has been associated over two decades with reports of severe liver damage. The clinical presentation of nimesulide-related-hepatoxicity includes, malaise, pruritus, a wide range of ALT/AST elevation, and an average 4 fold elevation of alkaline phosphatase and GGT. Liver biopsy shows a predominance of hepatocellular involvement, less frequently cholestatic and mixed patterns. Both, the hepatitis pattern and the mixed-type combining cholestatic jaundice, might evolve into fulminant hepatic failure. However, the incidence of nimesulide-inducedhepatotoxicity is not homogeneous across the medical literature. Indeed, most of the countries find it to be comparable to that of other NSAIDs, while a significant higher hepatotoxicity is suggested by reports from Finland, Ireland and Argentina. Our series in Argentina comprising 43 cases is worrisome particularly because it evidences a significant proportion of severe forms. In the present work we analyze the epidemilogical characteristics of nimesulide-induced-hepatotoxicity and we describe the clinical and histologic spectrum of nimesulide-associated-liver damage based on the comparison of our series of 43 cases and worldwide published observations in the pertinent medical literature.

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Nimesulide: clinical and histological evidences of severe hepatotoxicity

Cited by 7 publications

References 0 publications

A clinical study on nimesulide hepatotoxicity

A clinical study on nimesulide hepatotoxicity

The Concepts and Prospects of Nimesulide Induced Hepatotoxicity

The Spectrum of Nimesulide-Induced-Hepatotoxicity. An Overview

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