The Spanish Agency for Medicines and Health Products (AEMPS) has reported that the European Medicines Agency (EMA) has initiated a review of medicines containing metamizole (alone or in combination with other active ingredients) in relation to with the risk of agranulocytosis. In Spain, it is best known for the brand Nolotil, the most used painkiller in the country.
The review is initiated at the request of the Finnish Medicines Agency, at the request of the marketing authorization holder to withdraw the only authorized product containing metamizole in that country, due to the notification of cases of agranulocytosis.
The Pharmacovigilance Risk Assessment Committee (PRAC) will evaluate the available evidence in relation to the risk of agranulocytosis for all medicines containing metamizole authorized in the European Union (EU), in their different indications of use. use and existing risk minimization measures.
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After completing this evaluation, the PRAC will issue the appropriate recommendations that must subsequently be ratified by the European Coordination Group (CMDh), of which all European medicines agencies are part – in Spain, the Spanish Agency for Medicines and Health Products (AEMPS). )- and, ultimately, by the European Commission, which will conclude with a final and binding decision for the entire EU.
Metamizole is an analgesic and antipyretic active ingredient marketed in Europe since 1922 and is currently available in 19 Member States with variable use between countries.
Metamizole is an analgesic and antipyretic active ingredient marketed in Europe since 1922.
In December 2023, the AEMPS issued an information note in which it maintained the recommendations to prevent the risk of agranulocytosis with metamizole after carrying out an evaluation of the new information available since 2018.
In addition, the AEMPS has carried out a pharmacoepidemiological study in the BIFAP database (Database for Pharmacoepidemiological Research in the Public Environment), which is pending publication (EUPAS41314). As a preliminary conclusion, this study confirms that the incidence of agranulocytosis among patients who start treatment with metamizole is very low, in the range of 1 to 10 cases per million users in a patient population representative of real clinical practice in Spain. , including patients who were on treatments for several weeks.
The AEMPS will communicate the conclusions or new recommendations that arise once the review of the available information has been carried out.
Agranulocytosis is a known adverse reaction for metamizole, already described in its technical information and leaflet. It consists of a sudden decrease in neutrophils, a type of white blood cells, which can predispose to the appearance of infections. Although its frequency of occurrence is very low, it is a serious adverse reaction that can lead to the death of the patient.
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