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Nimesulide: patients still exposed to a risk of severe hepatitis

    Prescrire International
    |June 9, 2011
    PubMed

    Insights

    Nimesulide, a nonsteroidal anti-inflammatory drug (NSAID), poses significant liver damage risks, particularly for young women. Despite warnings, it remains available, with severe hepatic events accumulating globally.

    Area of Science:

    • Pharmacology
    • Hepatology
    • Drug Safety

    Background:

    • Nimesulide, a nonsteroidal anti-inflammatory drug (NSAID), has been available since 1998.
    • Regulatory agencies in Spain, Ireland, and Italy have issued warnings regarding nimesulide's hepatic adverse effects.
    • By early 2008, 17 cases of nimesulide-induced liver damage requiring transplantation were reported across Europe.

    Purpose of the Study:

    • To evaluate the hepatic safety profile of nimesulide compared to other NSAIDs.
    • To assess the risk of severe liver damage associated with nimesulide use.
    • To highlight the unacceptable continued marketing of nimesulide given available therapeutic alternatives.

    Main Methods:

    • Retrospective study analyzing NSAID exposure in approximately 400,000 patients (1997-2001).
    • Analysis of the European pharmacovigilance database for reported cases of liver damage.
    • Review of case reports concerning nimesulide-induced liver damage requiring transplantation.

    Main Results:

    • Nimesulide is neither more effective nor better tolerated than other NSAIDs.
    • An Italian study indicated a doubled risk of severe liver damage with nimesulide compared to other NSAIDs.
    • The European pharmacovigilance database shows nimesulide is associated with more severe liver damage cases than other NSAIDs and cox-2 inhibitors, with young women being particularly at risk.

    Conclusions:

    • Nimesulide is associated with a higher risk of severe liver damage compared to other NSAIDs.
    • Liver damage can occur even at recommended doses and within 15 days of initial use.
    • The continued marketing of nimesulide is unacceptable due to accumulating reports of severe liver damage and the availability of safer alternatives.

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