Nimesulide, Banned 13 Years Ago Still Prescribed To Children; Govt Calls For ‘Sensitisation’ Drive

New Delhi: The Indian Pharmacopeia Commission (IPC) has urged drug manufacturers to ‘sensitise’ paediatricians and other healthcare professionals about the importance of not prescribing painkiller and anti-fever medicine Nimesulide to children. Notably, despite a 13-year-old ban on the use of the drug, reports of side effects continue to reach the drug monitoring agency indicating that the drug is still being prescribed, according to News18.

Notably, Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and is allowed to be sold for adult dosage in India. It helps relieve pain associated with various disease conditions and reduces high fevers not managed by general medicines. In 2011, the Union Ministry of Health and Family Welfare banned the pediatric use of Nimesulide 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,” the Union Health Ministry said in a press release on March 11, 2011.

However, despite the ban, the Pharmacovigilance Program of India (PvPI) – which monitors and collects information about adverse drug reactions (ADRs) and adverse events associated with pharmaceutical products is receiving complaints. 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, News18 reported.

IPC has written a letter to all drug makers who hold the marketing approvals of the drug to begin this drive. While reminding that the union health ministry in February 2011 prohibited the manufacture, sale and distribution of the drug, the letter dated October 1 said, “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” and urged all concerned healthcare professionals and consumers not to prescribe or use the Nimesulide formulations in children under 12 years of age. The letter put the onus of circulation of this warning on the marketing authorisation holders or pharma companies where they want them to “circulate this information and awareness poster” to all “paediatric physicians, consultants in their hospital and professional circle for spreading awareness…”

The new poster drafted by PvPI to drive awareness clarifies that “Nimesulide is a pain killer” and it is “prohibited for use in children below 12 years of age.” Depicting a child refusing to consume the medicine, the poster reads that the drug may cause “liver toxicity, serious skin adverse reactions like Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis,” the report added.