Society and culture of Nimesulide

Brand names

Nimesulide is available throughout the world as original product with the following trademarks: Sulide, Nimalox, Mesulid (Novartis, Brazil, Boehringer Ingelheim, Greece, Italy), Coxtal (Sanofi, China, Bulgaria), Sintalgin (Abbott, Brazil), Eskaflam (GSK, Brazil, Mexico), Octaprin, Nimside (Teva, Pakistan), Nise (Russia, Venezuela, Vietnam, Ukraine), Nilsid (Egypt); Aulin (Bulgaria, Czech Republic, Italy, Romania, Poland), Ainex, Drexel, Donulide, Edrigyl, Enetra, Heugan, Mesulid, Minapon, NeRelid, Nexen, Nidolon, Nilden (Mexico); Emsulide, Nimed, Nimedex, Nimesil (Czech Republic, Moldova, Latvia, Kazhakhstan, Georgia, Poland), Nimulid (Trinidad & Tobago), Nimutab, Nimdase, Nimopen-MP Nise, Nimuwin, Nisulid, Nodard Plus, Nicip, Nimcap, Nic-P, Nic-Spas, Nimupain (India); Mesulid, Novolid, Relmex (Ecuador); Remisid (Ukraine); Coxulid, Emulid, Frenag, Fuzo, Motival, Nimeksil, Nimelid, Nîmes, Nimesdin, Romasulid, Sulidin, Suljel, Thermo Sulidin (Turkey), Xilox (Hungary); Modact-IR (Pakistan); and ad Sulidene and Zolan for veterinary use. Many generic and copy-products also exist (Lusemin, Medicox, Nidol, Nimalox, Nimesil, Nimotas, Nimulid, Nizer, Sorini, Ventor, Vionim, Neolide, Willgo among others), new-aid, Nexulide (Syria), Nims, Nice, Nimulide (Nepal).

India 

There have been several reports of adverse drug reactions in India.On 12 February 2011, The Indian Express reported that the Federal Ministry of Health and Family Welfare had finally decided to suspend the pediatric use of the analgesic nimesulide suspension.From March 10, 2011, nimesulide preparations are no longer suitable for children under 12 years of age.On September 13, 2011, the Madras High Court quashed the moratorium on the manufacture and sale of the pediatric drug Nimesulide and Phenylpropanolamine (PPA).

EMA confirms positive reward/risk ratio

On September 21, 2007, EMA issued a press release regarding the liver-related safety review of nimesulide.The EMA concluded that the benefits of these drugs outweighed the risks, but the duration of use needed to be limited to ensure that the risk of liver problems to patients was minimized.Therefore, the EMA has restricted the use of nimesulide in systemic formulations (tablets, solution, suppositories) to 15 days.

Irish Medicines Council

The Medicines Council of Ireland has decided to suspend the sale of nimesulide on the Irish market and refer it to the EU Committee for Medicinal Products for Human Use (CHMP) for review of its benefit/risk profile.The decision follows six cases of potentially related liver failure reported to the IMB by the National Liver Transplant Unit at St.Vincent’s University Hospital. The cases occurred between 1999 and 2006.

Bribes

In May 2008, the main Italian daily Corriere della Sera and other media reported that a senior official of Italy’s pharmaceutical agency AIFA was filmed by police while accepting bribes from pharmaceutical company employees.The payments were allegedly made to ensure certain drugs were not scrutinized by drug regulators.The investigation began in 2005 amid suspicions that some of AIFA’s drug tests had been falsified.Eight people were arrested.Nimesulide can be purchased with a doctor’s prescription, which is kept at the pharmacy as a receipt, nominally allowing strong control over sales.The original manufacturer of nimesulide was Helsinn Healthcare SA of Switzerland, which licensed the drug in 1976. Following the termination of patent protection in 2015 several other companies began to manufacture and market nimesulide.