Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs

Traversa, Giuseppe; Bianchi, C.; Da, Roberto; Abraha, Iosief; Menniti‐Ippolito, Francesca; Venegoni, Mauro

doi:10.1136/bmj.327.7405.18

Cited by 188 publications

(177 citation statements)

References 13 publications

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“…These results confirm other epidemiological studies demonstrating a small risk of severe liver injury in patients taking nimesulide and other non-steroidal antiinflammatory drugs 77 . …”

Section: Hepatic Safetysupporting

confidence: 82%

Acute pain: a multifaceted challenge – the role of nimesulide

Kress

Baltov

Basiński

et al. 2015

Current Medical Research and Opinion

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“…These results confirm other epidemiological studies demonstrating a small risk of severe liver injury in patients taking nimesulide and other non-steroidal antiinflammatory drugs 77 . …”

Section: Hepatic Safetysupporting

confidence: 82%

Acute pain: a multifaceted challenge – the role of nimesulide

Kress

Baltov

Basiński

et al. 2015

Current Medical Research and Opinion

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“…Various reports of nimesulide hepatotoxicity [11,12] have been published, though how often this condition is reported is the subject of heated debate because spontaneous reports of adverse drug events are helpful warning signals, even if they do not allow clinicians to determine incidence or relative risk. Data obtained from population-based epidemiological studies reporting the incidence or comparative risks of hospitalisation and death are, in fact, lacking.…”

Section: Introductionmentioning

confidence: 99%

Clinical course and outcomes of drug-induced liver injury: Nimesulide as the first implicated medication

Licata

Calvaruso

Cappello

et al. 2010

Digestive and Liver Disease

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a b s t r a c tBackground and aims: Drug-induced liver injury (DILI) is the most common cause of death from acute liver failure, and accounts for approximately 13% of cases of acute liver failure in the United States. The clinical presentation of DILI covers a wide spectrum, from asymptomatic liver test abnormalities to symptomatic acute liver disease, prolonged jaundice and disability, or overt acute or subacute liver failure. The aim of our study was to evaluate the number of DILI cases admitted to our Unit and to identify the drugs responsible. Thus, we reviewed all clinical records of patients with DILI admitted to our Unit from 1996 to 2006. Patients and methods: A database was constructed, reporting demographic, clinical features at onset, laboratory results, suspected drugs and follow-up. Liver damage was defined as hepatocellular, cholestatic or mixed, according to clinical and laboratory data. Results: Forty-six patients were admitted with a diagnosis of DILI. Presentation was jaundice in 22 patients and hepatic failure in 3 (all attributed to nimesulide). Liver damage was of a cytolytic pattern in 19 cases (41%), cholestatic in 15 (33%) and mixed in 12 (26%). Jaundice was found to be higher in nimesulideinduced liver damage compared to other drugs (p = 0.007). Three out of 14 patients with nimesulideinduced DILI developed encephalopathy and/or ascites. Time of recovery in the nimesulide group was significantly lower than DILI from other drugs (p < 0.001). Conclusion: Non-steroidal anti-inflammatory drugs, psychotropic drugs and antimicrobials are the most common causes of DILI. Nimesulide-induced DILI is usually reversible upon discontinuation of the drug, but occasionally progresses to liver failure.

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“…Traversa et al reported that, in a cohort study of thousands of patients taking various NSAIDs, ibuprofen was found to have a very low rate of liver toxicity, despite the massive use of this drug worldwide (8). Furthermore, several other studies and meta-analyses have failed to include severe liver injury as a side effect of ibuprofen use (9,10).…”

Section: Discussionmentioning

confidence: 99%

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

et al. 2015

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A 36-year-old Japanese woman took over-the-counter (OTC) medication for headaches for 20 days. Subsequently, five days after discontinuing the medication, a skin rash developed over the patient's upper and lower limbs and face, in addition to a fever, brown urine and serious liver dysfunction. Drug lymphocyte stimulation tests implicated ibuprofen, a main component of the OTC drugs, which has the potential to induce this pathology, and a diagnosis of drug-induced liver injury with multiform exudative erythema was made. The patient's symptoms and liver function tests returned to normal following treatment with systemic steroids.

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Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs

Abstract: Objective To estimate the risk of acute hepatotoxicity associated with nimesulide compared with other non-steroidal anti-inflammatory drugs.

Cited by 188 publications

References 13 publications

Acute pain: a multifaceted challenge – the role of nimesulide

Acute pain: a multifaceted challenge – the role of nimesulide

Clinical course and outcomes of drug-induced liver injury: Nimesulide as the first implicated medication

Drug-induced Liver Injury with Serious Multiform Exudative Erythema following the Use of an Over-the-counter Medication Containing Ibuprofen

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