All formulations of the popular painkiller Nimesulide above 100 milligrams should be banned, and a “black box” warning made mandatory on all products containing the drug, says the report prepared by the country’s top medical research body, the Indian Council of Medical Research (ICMR), following a request from the Drug Technical Advisory Board (DTAB).
Highlighting the poor safety profile, an 11-page report on Executive Summary Effect of Nimesulide in Adult Humans, accessed by News18, suggests that the drug should be reserved only as a second-line treatment and should be used only after all first-line options have been tried and found ineffective.
“The findings of this report underscore the need for stricter regulatory oversight and improved public awareness regarding the use of nimesulide in adult populations. While nimesulide remains an option for management of fever and pain, its poor safety profile necessitates careful consideration, particularly among high-risk groups,” said the report in the conclusion. “This report is submitted for consideration by the Drug Technical Advisory Board (DTAB) to implement the recommendations.”
The expert panel, in January 2024, during the 90th DTAB meeting, commissioned ICMR to assess the drug’s impact on adults. DTAB falls under the country’s apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO). All recommendations of DTAB are submitted to the Drug Controller General of India (DCGI), who heads CDSCO, for final approval.
“ICMR report has already been considered by DTAB and its recommendations may soon come into effect, once approved by DCGI,” a top source privy to the development told News18. “However, a pharmaceutical company, DR Reddy’s, has submitted a representation against the ban on the drug and has mentioned that the drug is safe in the adult human population. DTAB will now deliberate and give recommendations in this matter.”
In February, India banned the use of the drug for animal use. News18 has earlier reported how the government is trying to educate the healthcare community about the side effects of the drug.
Why is Nimesulide under the scanner?
First launched in Italy in 1985, Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has been widely used in India for its analgesic and antipyretic properties. Nimesulide is available in India under brand names. However, safety concerns have emerged over its adverse effects, particularly side effects on the liver, leading to regulatory scrutiny and action in various countries.
The European Medicines Agency (EMA) restricted its use in 2002 to adults only, and since then, many countries, including the United Kingdom, the United States, Canada, Australia, Singapore, and Japan, have imposed bans or strict usage guidelines for both human and veterinary applications. It is only in India and Pakistan that the drug is available for consumption by the elderly and adults.
In 2011, the apex drug regulatory agency of India, the Central Drugs Standard Control Organisation (CDSCO), banned the use of Nimesulide in children below 12 years following reports of severe liver damage.
“Recent concerns have been raised regarding its continued use in adult populations, especially in high-risk groups, prompting review by the Drug Technical Advisory Board (DTAB),” said the ICMR report in its background. “Furthermore, a High Court directive has mandated the evaluation of reasons for the non-ban of nimesulide in India, aligning with the vulture conservation efforts that led to the veterinary ban recommendation.”
It added that “During the 90th DTAB meeting, it was agreed to ban on veterinary use of all formulations of nimesulide. Further, it was decided that ICMR may also be requested to study the effect of nimesulide on adult human beings for further course of action in light of the fact that nimesulide drug has been prohibited in children below 12 years of age.”
Recommendations for CDSCO
According to the ICMR report, which is prepared by conducting a review of literature, evaluating international regulatory status, and stakeholder consultations, Nimesulide continues to be widely used in India due to a lack of awareness among healthcare providers and the public regarding its adverse effects. “Even though nimesulide is a Schedule H prescription medicine, it is available as an OTC medicine in India,” it said.
Hence, to tighten the regulations around the drug, ICMR has proposed eight recommendations for the drug regulatory body, CDSCO.
ICMR suggests enforcing OTC restrictions on the sales of the drug, which means the drug cannot be purchased without a valid prescription from a registered medical practitioner.
Also, it suggests that “all formulations of nimesulide above 100 mg should be banned”.
It has proposed “CDSCO to ask manufacturers to place a black box warning on the nimesulide labels for all medicines that contain nimesulide, whether single agent or combination.”
A black box warning is the most severe warning issued by regulatory agencies, such as the US Food and Drug Administration (FDA), for prescription medications. It alerts healthcare professionals and patients about serious or life-threatening risks associated with the drug’s use.
ICMR has also suggested that “Nimesulide should be used only as a second-line drug, only after exhausting first-line options” along with imposing age restrictions. It suggests that Nimesulide should be banned in patients below 18 years, as well as those who are 60 years and above.
“Nimesulide should not be used in pregnancy, lactating mothers, or people planning for pregnancy,” the report said.
Also, Nimesulide should not be used in patients with renal and hepatic (liver) impairment and also should not be co-administered with other hepatotoxic and renal toxic drugs.
The ICMR report also suggests active post-marketing surveillance or phase IV clinical trials by all manufacturers of all medicines containing nimesulide, irrespective of when the approval was obtained
Source: News18
