Nimesulide to carry warning box

Written by fe Bureau | New Delhi | Updated: Apr 21 2012, 06:01am hrs
After banning the marketing of paediatric Nimesulide last year, the drug regulator has now asked pharma firms selling analgesic Nimesulide for adults to put a warning box on the package stating that use of the drug should be restricted normally to 10 days. The warning would also say that if the situation warrants a longer use of the medicine on a person, a liver function test should be performed periodically thereafter to assess the impact of the drug on the liver of the person.

The Nimesulide retail drug market for adults in the country, inclusive of combination drugs (of which Nimesulide is a constituent), according to a 2011 estimate, was valued at over R2,500 crore. The pure Nimesulide market had, however, shrunk to R300 crore by 2011.

Drug Controller General of India (DCGI) GN Singh has asked the drug firms to display the warning in a conspicuous manner on labels, cartons, package and even the promotional literature. The drug regulator has further directed the state drug regulators across the country to oversee the implementation of the move. Many European countries pulled out the drug from the market in early 2000s after clinical studies found that it may cause liver toxicity.

Nimesulide has never been approved for use in many regulated markets such as the US, UK, Canada, Australia, New Zealand and Japan in view of the concerns over its safety profile, according to Europes therapeutics initiative. And some other countries such as Ireland and Singapore decided to withdraw nimesulide from the market in 2007. Many drug regulatory experts have been of the view that this drug should be phased out of India as well.

A few months back, the drug controller said that formulations of paracetamol in combination with other drugs cant have a weight of more than 325 mg of the popular analgesic to avoid potential damage to a patients liver from overuse of the medicine. A US FDAs decision of last year prompted the decision of DCGI. The regulator at that time also made it mandatory for all manufacturers of these combination drugs to put a box-label on the formulation packs, warning the patient-consumer of potential liver toxicity if the drug is consumed more than the recommended daily dose. It has however, allowed a period of three years to drugmakers to make the transition.