Banned 13 years ago, Nimesulide is still prescribed to children; Government Joins Sensitization Drive – News18

Despite a 13-year ban on the use of the pain reliever and antipyretic drug Nimesulide in children, reports of side effects continue to reach the drug watchdog – indicating that the drug is still being prescribed , News18 has learned.

Following these results, the watchdog Indian Pharmacopeia Commission (IPC) has urged drug manufacturers to ‘warn’ pediatricians and other healthcare professionals about the importance of not giving this drug to children.

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and is approved for sale for adults in India. It helps relieve pain associated with various disease states and reduce high fever that is not controlled by general medicine.

In 2011, the Union Ministry of Health and Family Welfare banned the use of Nimesulide in children under 12 years of age.

In many countries, products containing Nimesulide are not approved for children under the age of 12. This drug is considered hepatotoxic and children are considered at risk of developing liver disease, “Union Department of Health said in a statement dated March 11, 2011.

However, despite the ban, the Pharmacovigilance Program of India (PvPI) – which monitors and collects information on adverse drug reactions (ADRs) and adverse events related to pharmaceutical products – receives complaints.

According to the letter, obtained by News18, the Indian Pharmacopeia Commission (IPC) – which runs the Pharmacovigilance Program of India (PvPI) – has decided to launch an “action” on health professionals and consumers to do not use the drug Nimesulide in children under 12 years of age.

The IPC has written a letter to all drug manufacturers who have marketing authorization for the drug to initiate the process.

Publish information and post notices

While reminding that the Ministry of Public Health in January 2011 prohibited the manufacture, sale and distribution of the drug, the letter dated October 1 said, “PvPI is receiving reports that Nimesulide has caused adverse drug reactions from marketing authorization holders under PvPI.”

It also called for action in the interest of “pediatric patient safety” and urged all health professionals and concerned consumers not to prescribe or administer Nimesulide to minors. 12.

The letter placed the responsibility for the publication of this warning on marketing authorization holders or pharma companies where they are required to “tell this information and warning poster” to “pediatricians, consultants in their hospital and a professional center for spreading awareness…”

What does the new poster say?

A new poster prepared by PvPI to raise awareness, seen by News18, states that “Nimesulide is a painkiller” and is “prohibited for use in children under 12 years of age.”

Showing a child refusing to take the medicine, the poster reads that the drug can cause “liver toxicity, adverse skin effects such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis.”

An old practice, doctors who don’t know can still prescribe: Specialists

Dr. Dinesh Raj, a pediatrician at Delhi’s Holy Family Hospital, was surprised to see Nimesulide used so far.

“Nimesulide is banned in children but, surprisingly, it is still being used. Doctors may not know about the negative effects of Nimesulide in children,” he said while explaining that this medicine is used for fever and pain.

“Besides the common side effects of gastritis, vomiting, abdominal pain etc., it has been associated with serious side effects such as stomach bleeding and liver failure,” he added. by saying.

Dr GV Basavaraja, president of the Indian Academy of Pediatrics (IAP), told News18 that such a mistake can only be made by those who are old doctors and are not updated with the current guidelines.

Also, he said that in remote health care areas such as community health centers (PHCs) or community health centers (CHCs), many pediatricians are not available and are doctors who general or other counselors who give drugs to children. “In this situation, there is a great opportunity to prescribe Nimesulide as doctors (who treat adult patients) may not be aware of the contraindication in children.”

Basavaraja, who is also a renowned pediatrician based in Bengaluru, said that in the last 15 years, he has not written a single prescription for Nimesulide. “The IAP strongly recommends that doctors should not prescribe this drug to children and we will send advice to our 50,000 members again as a reminder.”

Echoing similar sentiments, Dr Maninder Dhaliwal, a pediatric pulmonologist 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, the changes in management are not as well communicated, perhaps in small or rural settings. I don’t think there is a pediatrician who prescribes nimesulide for fever. The prevention is clear but some doctors may prescribe it due to lack of awareness, since in adults it is being used,” Dr. Dhaliwal said.

He also said that “habit and familiarity with the drug in adult medicine can lead to a better understanding of nimesulide. Or sometimes the habits may continue even after regulatory changes, and if only it would be rare.”