BarcelonaMetamizole is the active ingredient in Nolotil, one of the most widely used painkillers in Spain and one of the most prescribed medicines for severe pain and treatment of inflammation, although it should not be the first medicine for these symptoms. Now the European Medicines Agency (EMA), in English, has begun a safety review of this ingredient to analyze what are the risks of agranulocytosis, a disorder characterized by a sudden decrease in white blood cells that can lead to serious infections, as well as increased susceptibility to infections.
The Public Prosecutor’s Office of the National State Court already reported last April that it was opening an investigation to study possible harmful effects associated with the consumption of metamizole. The Public Ministry opened preliminary procedures based on a complaint filed by the El Defensor del Pacient association against this analgesic, which has been marketed for more than 50 years and which has been under the spotlight for about five years due to its side effects. In fact, Nolotel has already been recalled from several countries such as the United Kingdom or Sweden.
Now Europe is looking into this drug. The origin of this latest research is Finland, where the only drug approved so far containing metamizole has been withdrawn. Approved uses for this pain reliever vary from country to country and range from treating pain after surgery or injury to treating pain and fever associated with cancer. In the European Union there are 19 countries that allow medicines containing metamizole, including Spain, which has agranulocytosis as a side effect.
Specifically, this effect consists of a sudden, sudden drop in levels of granulocytes, a type of white blood cell, which can cause serious infections that can be fatal, according to the European Medicines Agency. The product information for many medicines containing metamizole currently list agranulocytosis as a rare side effect – which may affect up to 1 in 1,000 people – or a very rare side effect – which may affect up to 1 in 10,000 people.
The European Medicines Agency (EMA) Safety Committee will now review the agranulocytosis risks of all metamizole-containing medicines authorized in the EU, as well as measures to reduce existing risks. The Commission will assess the impact of the disruption on the balance between the benefits and risks of medicines and make a recommendation on whether marketing authorizations should be maintained, diversified, suspended or revoked across the EU.
Controversy since 2018
The controversy over metamizole in Spain dates back to 2018, when the Spanish Agency for Medicines and Health Products (Aemps) recommended health professionals not to prescribe or use Nolotil in tourists arriving from northern Europe due to reports of serious secondary reactions; And even the deaths of Britons who were treated in the country with this drug. In fact, it is suspected that Nordic and British populations are more susceptible to agranulocytosis.
In 2022, 27.8 million Nolotel units were sold in the state, according to Efe. To consume this medication, it must be prescribed by a doctor. The incidence of this disease in Spain is considered “extremely exceptional”, amounting to about 5 cases per million inhabitants. It is a known side effect, but with a very low prevalence in southern Europe, it is not known why the incidence is slightly higher among northern populations, especially the UK and Ireland.
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