The ban on Nimesulide has opened discussions on the wide usage of painkillers.
For years, nimesulide was one of those medicines almost every Indian household seemed to know. A fever? Body ache? Tooth pain? Someone would casually suggest a tablet, often without much thought. It worked fast, relieved pain quickly. That reputation made it incredibly popular, especially among chemists and the general public.
Simply put, nimesulide delivered quick relief. Many users felt it acted faster and stronger, especially for inflammation and fever. It was also aggressively marketed in the past and easily available over the counter, which made self-medication common. In many places, you didn’t need a prescription, you just named the problem and the pill was handed over.
The problem, however, was what people didn’t see. Over time, concerns grew about its safety. This eventually led regulators in India to ban or restrict its use, particularly in pediatric patients.
Despite this, nimesulide became a “go-to” drug because of habit, accessibility, and lack of awareness.
Frequent NSAIDs use warrants caution
"Nimesulide has been a commonly used NSAID (Non-Steroidal Anti-Inflammatory Drug) for quite some time now in India because of its faster onset of action.
But evidence has also been emerging over the last several decades that its safety profile significantly decreases with increases in its dosage levels (200mg/day) as well as its duration of action (more than 15 days). Available literature also points out that nimesulide can induce hepatotoxicity with instances of liver damage, as well as liver failure, reported among a few patients within a couple of days of its administration," Dr. Mukesh Thakur – Director, Internal Medicine, Acute Medicine & Clinical Transformation, Sir H. N. Reliance Foundation Hospital told TOI Health. He adds:
- Non-steroidal anti-inflammatory drugs act by inhibiting cyclo-oxygenase enzymes, which cause inflammation and pain
- The class also poses certain risks to the gastrointestinal system, renal system, cardiovascular system, and liver if abused or overused, especially when taken in higher doses for certain chronic ailments.
- Since safer first-line analgesics such as paracetamol, also known as acetaminophen, when taken at prescribed doses, monitoring is not required
- The indiscriminate and widespread use of analgesics, without proper medical guidance, merely conceals the problem without correcting its causes.
- This delays the diagnosis of severe ailments and renders a person prone to cumulative toxicity.
- NSAID-induced gastrointestinal and renal intolerance are well documented in patients using several analgesic drugs concomitantly.
- Individuals with underlying liver issues, alcohol use, and other comorbid conditions like diabetes and hypertension can be at high risk of quickly accumulating toxicity.
Several studies have found a direct link between high doses of nimesulide and health risks. Systematic review and meta-analysis of 25 studies found nimesulide associated with hepatotoxicity; 45.5% of severe cases needed transplantation or were fatal. Spanish case-population study calculated rate ratio 4.6 (95% CI 2.9–7.2) for acute liver injury within 30 days of use. European case-population from transplant registries estimated individual attributable risk of 1 in 1490 for acute liver failure leading to transplantation.
Study finds unexpected side effects of common painkillers
Marketing and sale of nimesulide was banned in Finland and Spain in 2002 and in Ireland in 2007 because of serious side effects affecting the liver. The drug was prohibited in Malaysia (2008), Singapore (2008), Vietnam (2008) and Argentina (2009).
"For those on existing treatments with high doses of nimesulide, it is necessary to consult a healthcare provider and discontinue treatment immediately," he recommends. Alternatively he suggests non-pharmacological pain management tools like physiotherapy and lifestyle changes and other options like paracetamol, ibuprofen, diclofenac (at approved doses).