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The Truth About Nimesulide: Why Did the US and Other Countries Ban This Drug?

Written by Sara Aquino
Published 14/02/2025 às 11:48
Nimesulide, a popular drug in Brazil, is banned in the US due to health risks, especially liver damage. Find out why!
Photo: IA

Nimesulide, one of the anti-inflammatory drugs most consumed in Brazil, its safety is questioned in several countries. Despite its popularity in Brazil, where it ranks third among the best-selling drugs, this drug is banned in the United States, Canada, Japan, Spain, Ireland and other countries due to serious health risks, especially related to liver damage.

Nimesulide belongs to the class of non-steroidal anti-inflammatory drugs (Ines) and stands out for its triple action: anti-inflammatory, analgesic and antipyretic.

This means that it is capable of relieving inflammation, pain and fevers, making it a quick and effective option for various clinical conditions.

In Brazil, more than 102 million boxes of the medicine were sold in a single year, according to consultancy Close-Up International.

This sales volume reflects the frequent use of the substance by patients seeking quick solutions for pain and inflammation. However, experts warn of the dangers of indiscriminate use.

Risks and side effects

Despite its effectiveness, nimesulide can cause serious adverse effects. One of the main problems is its relationship with liver damage, which can occur even with short-term treatments.

Reported symptoms include nausea, vomiting, diarrhea, dizziness and allergic reactions.

In more severe cases, there may be drug-induced hepatitis, liver failure and even the need for a liver transplant.

A recent study analyzed 468 cases of liver injuries drug-induced deaths in Latin America, and nimesulide was among the drugs associated with the worst prognoses. As a result, authorities in several countries decided to ban or restrict its use.

Why is nimesulide banned in the US?

In the United States, Food and Drug Administration (FDA), the drug regulatory agency, never approved nimesulide due to the proven risks of hepatotoxicity.

The decision was based on evidence that the drug can cause liver failure, even at therapeutic doses.

Ireland, for example, immediately suspended sales of the drug in 2007 after reports of severe cases of liver failure.

Since then, the European Medicines Agency (EMA) has imposed severe restrictions on the use of nimesulide, limiting its prescription to specific cases and for short periods.

Nimesulide in Brazil

Unlike the United States and other countries that have banned the drug, nimesulide remains widely available in Brazil.

The National Health Surveillance Agency (Anvisa) requires a medical prescription for its acquisition, but experts warn that sales and excessive use still occur without proper supervision.

Hepatologist Raymundo Paraná highlights that the culture of self-diagnosis and the ease of purchasing without control are factors that aggravate the problem.

“Many patients take anti-inflammatories as if they were harmless painkillers, but they forget about the risks to the liver, kidneys and cardiovascular system,” he warns.

safe alternatives

Given concerns about the safety of nimesulide, experts recommend safer alternatives for treating pain and inflammation.

Painkillers such as paracetamol and dipyrone are often suggested, as they pose less risk to the liver when used correctly.

Furthermore, it is essential that the use of any medication is guided by a health professional, avoiding self-medication and its adverse consequences.

Although nimesulide remains available in Brazil, its history of being banned in several countries, including the United States, raises an important warning.

Indiscriminate use can pose significant health risks, reinforcing the need for greater regulation and awareness of its potential adverse effects.

Therefore, it is essential that patients seek medical advice before using the medication and consider safer options for treating pain and inflammation.

with the BBC

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Ruth Michel Kehde
Ruth Michel Kehde
14/02/2025 23:08

I believe that if it is an unreliable medicine, it should be banned from use in Brazil. The United States is a reference in health, among other developed countries.

Sara Aquino

General Pharmacist and Writer. I write about Jobs, Courses, Science, Technology and Energy. Passionate about reading, writing and music.

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