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Journal of Postgraduate Medicine, Vol. 55, No. 1, January-March, 2009, pp. 73 Letter Comment on: Nimesulide and adverse drug reactions: Time for a database Bissoli F Department of Internal Medicine, Clinica San Gaudenzio, Via Bottini 3, Novara 28100 Code Number: jp09018 Sir, I agree with Dr. Khan on the interest of a recently reported case of hepatitis and toxic epidermal necrolysis linked to nimesulide use, considering that apparently no case of this association has been previously published. [1],[2] In fact, spontaneous reports of adverse drug events are helpful warning signals of rare toxicities. It is to be, however, underlined that spontaneous reports do not allow us to determine incidences or relative risks, and can lead to spurious and potentially misleading conclusions. [3],[4],[5] More meaningful data may be obtained from population-based epidemiological studies reporting on the incidence or comparative risk of hospitalization and/ or death. [3] Based on such studies, the risk of serious liver injury due to the use of NSAIDs is quite low. [3] Although NSAIDs are cited as a common cause of liver damage, the apparently high "incidence" of NSAID-induced liver injury, reflects a much frequent use of these medications in the general population. [6] Very few fatal cases related to NSAID use have been reported, suggesting that the mortality rate is likely to be lower than 1/100,000 patient-years. [3] The largest epidemiological population-based study (almost two million prescriptions) specifically focused on nimesulide vs. other NSAIDs, demonstrated for this NSAID only a small risk of hospitalization for acute liver injury, without cases of transplantation or death due to liver damage. [7] The European Medicine Agency (EMEA) has recently confirmed that the occurrence of serious hepatic adverse reactions following nimesulide use is very rare, and that the drug′s benefit/risk profile is positive. [8] Regarding pediatric use of nimesulide, its administration is contraindicated in children below 12 years. These observations could help mitigate the concerns expressed about nimesulide. Obviously population-based studies need to be carried out in India for proper assessment. It also needs to be clarified that the original Marketing Authorization Holder years ago decided to withdraw from the registration process of nimesulide in Australia and New Zealand and not to require its registration in the US and Canada only for commercial reasons (nimesulide was an out-of-patent drug and therefore open to generic competition), not for safety problems. [9] References
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