The lancet more early reported Nimesulde's adverse effects, especially hepatic and kidney damage in 1999. And several papers discussed thoroughly the use of Nimesulide in children, from perspective of pharmacology study, clinical case and new drug registration. (1-6)

     In the following decade, The debate about Nimesulide's drug safety isn't over. With ADRs reported increasingly, more and more countries banned or suspensioned Nimesulide fomulation. howerer, EMEA is confident that nimesulide has a positive risk-benefit profile，respectively in 2004 and 2007 Nimesulide 's therapeutic indications was restricted to three conditions by EMEA.

        Nimesulide, as 'me-too drug', was popular in developing countries such as India, China, etc. There are more than 50 brands available in Chinese market, even several manufacturers competed for one same formulation, due to patent expiration and low production cost. In the end of 2010, fatal ADR of Nimesulide addressed by the media, and ambiguous reports titled Nimesule as "fetal antipyretics". in authorities opinion, no abnormal ADR data was found, and Nimesulide is still allowed in the market. In addition, the domestic leading manufacturing companies accused J&J of spreading rumors about nimesulide.

On the contrary, paediatric Nimesulide was banned in India lastly, where Nimesulide was ever used as pediatric antipyretic as common as China.

     The current controversy of nimesulide remind China , to be third largest pharma market in 2011, need to strengthen drug control in all life-cycle of a drug including new drug registration, postmarketing drug surveillance system, prescribing drug regulation, etc.