The paediatric use of Nimesulide, a Non-steroidal non-inflammatory drug (NSAID), has been banned in India. The union health ministry upon recommendations by the experts on the Drug technical advisory board decided to ban the paediatric drug as it is known to cause liver injury.
Nimesulide, which has anti-pyretic, analgesic and anti-inflammatory effects, was first launched in Italy in 1985. The original patent for Nimesulide is US3840597, assigned to RIKER LABORATORIES INC., which was granted in 1974. A search for Indian patents/patent application discloses around 196 entries which refer to Nimesulide. It was marketed in over 50 countries for the treatment of acute pain associated with osteoarthiritis. The drug has been in controversy for over 10 years. The drug was withdrawn in many countries due to its hepatotoxic repercussion. Many cases of Nimesulide induced hepatotoxicity have been reported.
Following the realization of the Nimesulide associated hepatotoxicity, EMEA (European Agency for the Evaluation of Medicinal Products) in 2003 banned the use of Nimesulide in children below 12 years. India was, however, “contemplating” the ban of Nimesulide for a long time (apparently). The ban on paediatric use of Nimesulide was much awaited and welcomed by industry experts and medical specialists.
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