Nolotil under the microscope: EMA launches review of most widely sold medication in Spain, due to safety fears

Nolotil under the microscope: EMA launches review of most widely sold medication in Spain, due to safety fears

The European Medicines Agency has initiated a review of drugs containing the analgesic metamizole, alone or in combination with other active ingredients

Europa Press


Monday, 17 June 2024, 16:06

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European health authorities are investigating a painkiller widely sold in Spain under the brand name Nolotil due to the risk of it allegedly causing serious infections.

The Spanish Agency for Medicines and Health Products (AEMPS) announced the European Medicines Agency (EMA) is looking into medicines containing the analgesic metamizole. In Spain, it is the active ingredient in Nolotil, the most widely sold and consumed branded medicine in the country.

The EMA has placed the medicine under the microscope at the request of the Finnish Medicines Agency, following cases of agranulocytosis in people who had taken medicine containing metamizole. Agranulocytosis is a serious condition that involves having severely low white blood cell levels. It can lead to fatal infections without treatment.

The Pharmacovigilance Risk Assessment Committee (PRAC) will then assess the evidence regarding the risk of agranulocytosis for all metamizole-containing medicinal products authorised in the European Union (EU).

Metamizole in Spain

Metamizole has been marketed in Europe since 1922 and is currently available in 19 EU countries with use varying from country to country. In December 2023, AEMPS issued an information note with recommendations on usage and to prevent the risk of agranulocytosis with metamizole following an assessment of new data available since 2018.

AEMPS also conducted a study, which is pending publication, which confirmed the incidence of agranulocytosis among patients initiating treatment with metamizole is very low, in the range of 1 to 10 cases per million users in a patient population representative of actual clinical practice in Spain, including patients who were on treatment for several weeks.

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