There is another twist in the nimesulide tale that negates the claims of drug manufacturers and even the Indian Medical Association about the safety of the medicine. The European Medicine Evaluation Agency (EMEA) has banned the use of Nimesulide in children below 12 in all member countries. The decision was announced early this month after a 16-month-long review of the controversial drug.The referrence to the use of drugs in children was made after Finland sought the EMEA’s advice on the hepatotoxicity of the drug in adults. While allowing its use in adults, the EMEA has restricted its approved indications to acute pain associated with osteoarthritis and dysmennorhoea only. Its use in fever is not permitted. Also it cannot be used for dental diseases such as pain and inflammation. Its topical form is to be used only for relief of pain due to sprains and acute inflammation of tendons due to injury (traumatic tendonitis) only.‘‘After the decision, even Italy, the only European country where Nimesulide is approved for use in older children (over the age of 6), will have to ban its use in all paediatric patients. Italy is the biggest user of Nimesulide in Europe,’’ Dr C.M. Gulati, former drug expert with WHO and editor of Monthly Index of Medical Specialities, said.This leaves India as the only country in the world where Nimesulide is being marketed for use not only in children but infants. The European decision might even question the findings of the IMA. ‘‘On the basis of an opinion poll among just 50 doctors out of over 400,000 doctors, the IMA came to the conclusion that Nimesulide was ‘safe and effective for all age groups starting with day 0 to over 60 years’ for a variety of conditions,’’ said Dr Gulati.The Drugs Controller General of India, in his response to a PIL, informed the Delhi High Court that there is no reason to ban the drug use on paediatric patients in India.There are over 70 brands of Nimesulide paediatric suspensions in the Indian market, including Nise of Dr Reddy’s and Nimulid of Panacea Biotec. Agreeing, Dr Gulati said: ‘‘Drug promotion in India depends more on providing incentives and less on accurate information. Sending prescribers on foreign jaunts, giving expensive gifts, including cars, is not uncommon.’’In the wake of the media outcry, the sale of Nimesulide preparations is steadily going down in India. It has already lost over 25 per cent of its market in the past six months.
