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Europe investigates the safety of Nolotil and its generic metamizole

The growing consumption of painkillers in Spain, with Nolotil leading

Jesus Carames

June 15, 2024 | 6:57 pm

Concerns about agranulocytosis

Europe has put the Nolotil and its generic, the metamizole o dipyrone, due to concerns about its possible link to cases of agranulocytosis, a rare and serious immune disorder. The European Medicines Agency (EMA, for its acronym in English) has initiated a comprehensive review of all medicines that contain this active ingredient, either alone or in combination with others.

The Spanish Medicines Agency announced this Friday that the review began at the request of its counterpart in Finland. The Finnish agency had requested the withdrawal of the only product authorized in that country with metamizole. This process will involve a detailed analysis by the Pharmacovigilance Risk Assessment Committee (PRAC, for its acronym in English), which will evaluate the scientific evidence on the risks of the drug.

Procedure and evaluation

The report of the PRAC It will not be final; must be ratified by the rest of the European medicines agencies and, finally, by the European Commission, which will make a final and binding decision for the entire UE.

El metamizole It is the most consumed analgesic in Spain. Marketed for more than a hundred years, it has always been considered safe, although it is known that on rare occasions it can trigger agranulocytosis. This side effect, although very rare, is serious and can even be fatal, since it causes a sudden decrease in neutrophils, a type of white blood cell, increasing the risk of infections.

Genetic predisposition

This disorder has been linked to a greater genetic predisposition in the Anglo-Saxon and Northern European population. For this reason, it was decided not to prescribe the drug in the United States and the United Kingdom.

In 2018, the Spanish Ministry of Health reviewed the effects of the drug after several cases of agranulocytosis in British patients. The decision was to advise against using the drug in the floating population, but no reason was found to withdraw it. The risks were considered within the ranges known for the Spanish population.

Last year, the Spanish Medicines Agency maintained the recommendations after carrying out a new evaluation, motivated by a complaint before the National Court by an association of people affected by the side effects of Nolotil. This association claims to know of at least 350 cases of infections caused by the consumption of the painkiller, some of them resulting in death.

Studies and statistics

The Prosecutor's Office requested information from the Ministry of Health about the manufacturing, importing, marketing and distributing companies in Spain, as well as about the authorizations granted and the communication of adverse reactions.

Subsequently, the Medicines Agency launched a pharmacoepidemiological study. Although this study has not yet been published, the first conclusions indicate that the incidence of agranulocytosis among patients who begin treatment with metamizole it is very low, appearing in a range of 1 to 10 cases per million users in a representative population of clinical practice in Spain.

With this ongoing research, European authorities seek to ensure patient safety and the effectiveness of treatments containing metamizole, ensuring that any risks remain within acceptable and well-known limits.

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