The benefits of medicines containing metamizole outweigh the risks in the authorised indications. This is the conclusion of the assessment carried out by the European Medicines Agency (EMA) on the risk of agranulocytosis associated with the use of metamizole alone or in combination with other active ingredients. This substance is better known in Spain by its trade name, Nolotil.
This assessment also strengthens measures to facilitate early identification of symptoms and diagnosis of agranulocytosis. In June 2024, EMA began a review of medicines containing metamizole at the request of the Finnish Medicines Agency. This revision follows the request of the marketing authorisation holder to withdraw the only authorised product containing metamizole in this country, following the notification of several cases of agranulocytosis.
Based on the evaluation of all available scientific evidence, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefit of metamizole-containing medicines exceeds the risks in the authorized indications and strengthens measures to facilitate the early identification of symptoms and diagnosis of agranulocytosis.
However, the information available to date does not allow us to exclude or confirm an increased risk in populations with specific ethnic or genetic characteristics. The conclusions of the PRAC assessment must be ratified by the EMA’s Coordination Group (CMDh), which includes all European medicines agencies.
The updated information will be included in the technical data sheet, intended to inform healthcare professionals, and in the leaflet, intended for the public, for medicines containing metamizole, which They can be consulted in the AEMPS Online Medicines Information Center (CIMA)..
