Despite a 13-year-old ban on the use of the painkiller and anti-fever medicine Nimesulide in children, reports of side effects continue to reach the drug monitoring agency – indicating that the drug is still being prescribed, News18 has learnt.
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.
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.
According to the letter, accessed by News18, 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.
IPC has written a letter to all drug makers who hold the marketing approvals of the drug to begin this drive.
Circulate information and awareness poster
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…”
What does the new poster say?
The new poster drafted by PvPI to drive awareness, seen by News18, 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.”
Old practice, unaware doctors may still prescribe: Experts
Dr Dinesh Raj, paediatrician at Delhi’s Holy Family Hospital, expressed surprise over the use of Nimesulide to date.
“Nimesulide is banned in children but, surprisingly, it is still being used. The practitioners may be unaware of the serious adverse effects of Nimesulide in children,” he said while explaining that this drug is used for fever and pain.
“Apart from the standard side effects of gastritis, vomiting, abdominal pain etc, it has been linked to serious side effects like gastrointestinal bleeding and liver failure,” he added.
Dr GV Basavaraja, president of the Indian Academy of Pediatrics (IAP), told News18 that such an error can only be made by those who are old-time practitioners and are not updated with the current guidelines.
Also, he said that in remote healthcare settings such as public health centres (PHCs) or community health centres (CHCs), many paediatricians are not available and it is general physicians or other consultants who prescribe the drug to children. “In this situation, there is a high chance of prescribing Nimesulide as those doctors (who treat adult patients) may not be aware of the ban among children.”
Basavaraja, also a well-known paediatrician based in Bengaluru, said that in the last 15 years, he hasn’t written a single prescription for Nimesulide. “IAP strongly advocates that doctors should not write this drug for children and we will send the advisory to our 50,000 members once again as a reminder.”
Echoing a similar point of view, Dr Maninder Dhaliwal, an expert in pediatric pulmonology at NCR-based Amrita Hospital, believes that not all doctors may be fully aware of the updated guidelines or may misinterpret the restrictions.
“In some cases, regulatory changes aren’t uniformly communicated, maybe to smaller or rural healthcare setups. I don’t think any paediatrician is writing nimesulide for bringing down fever. The ban is clear but some physicians might be giving it because of a lack of awareness, as in adults it is still used,” Dr Dhaliwal said.
He also said that “habit and familiarity with drugs in adult medicine might lead to comfortable prescribing of nimesulide. Or sometimes habits may persist even after regulatory changes, though it would be rare.”
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