Despite the use of the painkiller and fever reducer nimesulide in children being banned for 13 years, reports of side effects continue to arrive at drug watchdogs, suggesting the drug is still being prescribed. According to an investigation by News18, this is the case.
Following these findings, the watchdog Indian Pharmacy Council (IPC) has asked drug companies to “sensitize” pediatricians and other health professionals about the importance of not prescribing the drug to children. urged.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and is permitted for sale in adult doses in India. It relieves pain associated with various medical conditions and reduces high fevers that cannot be treated with over-the-counter medicines.
In 2011, the Union Ministry of Health and Family Welfare banned the pediatric use of nimesulide in children under 12 years of age.
“In many countries, products containing nimesulide are not allowed for use in children under the age of 12. This drug is considered to be hepatotoxic, and children are more susceptible to the effects of hepatotoxicity. “The Federal Ministry of Health said in a press release on March 11, 2011.
However, despite the ban, India’s Pharmacovigilance Program (PvPI), which monitors and collects information on drug-related adverse drug reactions (ADRs) and adverse events, has received complaints.
According to a letter accessed by News18, the Indian Pharmacopoeia Committee (IPC), which runs the Indian Pharmacopoeia Vigilance Program (PvPI) program, has advised healthcare professionals not to use the drug nimesulide in children under 12 years of age. The company has decided to start “sensitizing” consumers. age.
The IPC has written to all drug manufacturers that hold marketing authorization for this drug to begin this effort.
Distribution of information and awareness posters
Reminiscing that the Union Health Ministry had banned the manufacture, sale and distribution of the drug in February 2011, the letter dated October 1 said, “PvPI will still allow reports on nimesulide-induced side effects to be filed under PvPI. “We have received approval from the holder of marketing authorization in the country,” he said.
It also called for measures that take into account the “safety of pediatric patients” and asked all relevant healthcare professionals and consumers not to prescribe or use nimesulide in children under 12 years of age.
The letter places the responsibility on the marketing authorization holder or pharmaceutical company to distribute this warning and “distributes this information and awareness poster to all pediatricians, hospital consultants, and professional circles to spread awareness…” I’m asking you to distribute it.
What does the new poster say?
A new poster, seen by News18 and drafted by PvPI to raise awareness, clearly states that “nimesulide is a painkiller” and “not for use in children under 12 years of age.”
A poster depicting a child refusing to take the drug says the drug can cause “serious skin side effects including liver toxicity, Stevens-Johnson syndrome, and toxic epidermal necrolysis.” are.
Old practice, ignorant doctors may still prescribe: expert
Dr. Dinesh Raj, a pediatrician at Delhi’s Holy Family Hospital, expressed surprise at the use of nimesulide so far.
“Although nimesulide is prohibited in children, surprisingly it is still used. Practitioners may not be aware of nimesulide’s serious side effects in children,” says the drug, which is used to treat fever and pain. He said while explaining that it is used for.
“Apart from the standard side effects such as gastritis, vomiting and abdominal pain, there has also been an association with serious side effects such as gastrointestinal bleeding and liver failure,” he added.
Indian Academy of Pediatrics (IAP) president Dr GV Basavaja told News18 that such mistakes can only be made by traditional medical practitioners who are not updated with the current guidelines.
He also said that in telemedicine settings such as public health centers (PHCs) and community health centers (CHCs), many pediatricians are not available, leaving general physicians and other consultants to prescribe medicines to children. . “In this situation, physicians (treating adult patients) are more likely to prescribe nimesulide because they may not be aware of the prohibition for children.”
Basabaja, who is also a prominent pediatrician based in Bengaluru, said he has never written a prescription for nimesulide in the past 15 years. “The IAP strongly insists that doctors should not prescribe this drug to children and will be sending another advisory to its 50,000 members as a reminder.”
Dr Manidhar Dhaliwal, pediatric pulmonology specialist at NCR-based Amrita Hospital, echoed similar views, saying that not all doctors are fully aware of the latest guidelines or misunderstand the restrictions. I think there is a possibility that it is.
“In some cases, regulatory changes may not be communicated uniformly and may be passed down to smaller or rural health care facilities. I don’t think any pediatrician is writing nimesulide to lower a fever. The ban is clear, but it is still used in adults, so some doctors may be banning it due to lack of awareness,” Dr. Dhaliwal said.
He also said that “familiarity and familiarity with the drug in adult care may lead to comfort in prescribing nimesulide.” Or, although rare, the habit may persist even after the regulation changes. ”
