Side-effects of banned drug Nimesulide still reported in children: Report

A report claimed on Saturday that the side effects of painkiller Nimesulide are still being reported to the drug monitoring agency despite the medicine’s ban 13 years ago. This hints at the possibility that the drug is still being prescribed.
“Following these findings, monitoring agency Indian Pharmacopeia Commission [IPC] has urged drug manufacturers to ‘sensitise’ paediatricians and other healthcare professionals about the importance of not prescribing this drug to children,” News 18 reported on Saturday.
Nimesulide is used to relieve pain, inflammation, and fever. It belongs to a class of painkillers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) . In 2011, the Ministry of Health and Family Welfare banned the manufacture, sale and distribution of ‘nimesulide’ formulations for human use in children below 12 years of age.
“Nimesulide formulations in children below 12 years of age – Nimesulide containing products are not permitted in many countries in children under 12 years of age. The drug has been considered to be hepatotoxic and children are considered more susceptible to hepatotoxicity,” a statement issued by the Union health minister had stated.
Meanwhile, a research published in BMJ journal in 2003 said, “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,” a research published in the BMJ journal in 2003 stated.
However, despite the ban, the Pharmacovigilance Program of India (PvPI) is receiving complaints. The PvPI monitors and collects information about adverse drug reactions (ADRs) and adverse events associated with pharmaceutical products.
A letter accessed by News18 showed the Indian Pharmacopeia Commission (IPC) – which runs the Pharmacovigilance Program of India (PvPI) program – has decided to start ‘sensitisation’ of healthcare professionals and consumers to not use Nimesulide drugs in children under 12 years of age.
The letter dated October 1 reportedly read, “PvPI has been still receiving some reports of Nimesulide induced adverse drug reactions from marketing authorisation holders under PvPI.”
It further requested action in the interest of “paediatric patient safety”. It urged all concerned healthcare professionals and consumers not to prescribe or use the Nimesulide formulations in children under 12 years of age.