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Review Papers | Pharmacy | India | Volume 11 Issue 9, September 2022 | Rating: 4.6 / 10
Regulatory Profile of Nimesulide with its Adverse Event in Europe and Rest of the World
Krutika Sawarkar | Sakshi Sharma [4] | Amruta Shete | Mrunali Bhasme
Abstract: All of the formulations are intended for the prevention or treatment of disorders and diseases, with just a few medications being lifesaving and necessary; the rest are interchangeable. Due to a lack of law enforcement and medical awareness, banned medications are nonetheless available in developing countries like India. Some of these medications, such as Nimesulide, Rofecoxib, Phenyl propanamine, and other OTC remedies, have been banned by the European Medicines Agency (EMA) due to side effects such as agranulocytosis, kidney and liver failure, and are still on the market. That wasn't outlawed until 2011 in India, which was too late because it was still legal for adults to use their despite its hepatotoxicity and potential drug interactions. [1, 37, 43] Non-steroidal anti-inflammatory drugs (NSAIDs) and cyclo-oxygenase-2 (cox ?2) inhibitors are structurally heterogeneous drugs that share similar therapeutic actions and adverse effects. Hepatotoxicity, although a relatively rare adverse effect of this class of drugs, can be severe. These drugs have also been associated with idiosyncratic hepatotoxicity in susceptible patients. This has led to the withdrawal of some NSAIDs from the market. Nimesulide is an NSAID, with cox-2 preference, which has been reported to cause death from hepatic failure. However, most reports have been from European countries. Asian reports include that from Israel and India [4, 19, 21, 23, 38].
Keywords: Nimesulide, Europe, India, Hepatotoxicity, Regulatory Profile, Adverse effects
Edition: Volume 11 Issue 9, September 2022,
Pages: 74 - 79