Nimesulide to have ‘box warning’
With reports of Nimesulide causing liver toxicity red-flagged, the Drug Controller General of India (DCGI) has asked the manufacturers to add “box warning” on its label, suggesting that its use to be restricted to 10 days and if longer clinical use is necessary then liver function test should be assessed periodically. The health ministry had earlier last year banned the paediatric use of the analgesic Nimesulide after the sub committee of the government’s chief advisory body-the Drug Technical Advisory Board (DTAB) recommended for the same.
However, for the population of 12 years and above it has been decided that the box warning-“use of nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, be warranted, liver function test should be assessed periodically.”
In his recent letter to the state drug controllers, the Drug Controller General of India has asked that the box warning should be mentioned on label as well as package insert and other promotional literature of formulations containing nimesulide. “In view of above, you are requested to direct manufacturers of nimesulide containing formulations for use in patients of 12 years and above in your state to incorporate the box warning in a conspicuous manner on the label, carton, package insert and other promotional literature of the drug,” the letter said.
The drug has been under scanner for sometime now. While, the box warning-doctors say is a welcome step, they feel that it should be rather be made a scheduled drug and not over the counter drug. “It is a anti inflammatory and anti-pyratic drug. It is not the first line drug for fever pain or inflammation. The safest among this group is still paracetamol. Nimesulide specially in smaller children or in any age group who have even mild liver dysfunction or kidney impairement can rapidly worsen the liver and kidney function. In viral infections and fever in all age groups it causes platelet dysfunction and acute bleeding. It should also never be used in pregancy because it causes fetal kidney permanent damage,” said Dr Dr Sanjeev Bagai, senior consultant, pediatrician and nephrologist, CNMD, Nephron clinic.
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