Use of nimesulide in Indian children must be stopped

Editor—The continuing use of nimesulide for Indian children is shocking.¹ Numerous studies have established the life threatening hepatotoxic effects of nimesulide.²,³ Nimesulide is not used in the United States, and many European countries have also banned the drug because of its unacceptable rate of serious adverse reactions.

Although some studies have indicated that nimesulide may be chosen for osteoarthritis in selected patients with associated gastric problems, other non-steroidal anti-inflammatory drugs such as acetaminophen (paracetamol) are far better choices as antipyretics or analgesics, especially for children.⁴ No rationale exists for selecting nimesulide as the first drug of choice for fever or pain. Published studies from India indicate rampant abuse of nimesulide.⁵ At least 12 paediatric preparations of nimesulide are available in India, which affirms the widespread use of the drug in children.⁵

Hardly any dependable post-marketing surveillance for adverse drug reactions is undertaken in India. Moreover, unlike in the West, Indian doctors are not under any real supervision and therefore do not necessarily keep up with the rapidly changing information about adverse effects.⁵ Patients receiving nimesulide should be closely monitored for evolving hepatic failure. Indian patients may not follow necessary guidelines, for simple economic reasons. Even if the Indian drug control agencies are reluctant to impose a total ban on nimesulide, they should immediately forbid its use for treatment of fever or pain.

A plethora of scientific data show that nimesulide should not be used as the primary mode of treatment as an antipyretic or analgesic, especially in children, for whom much better and safer choices are available. It will be unfortunate if the Indian government waits for another “committee” report before stopping the use of nimesulide, even for the treatment of pain or fever, and lets more innocent patients suffer needlessly.