Based on the recommendation of the European Medicines Agency (EMA) and in cooperation with the Institute for Medicines and Medical Devices (CInMED), the company Alkaloid d.o.o. as the marketing authorisation holder for Analgin (metamizole sodium) has informed healthcare professionals about important measures to minimise serious outcomes of the known risk of agranulocytosis. Agranulocytosis is an already known adverse reaction to metamizole-containing medicines, which occurs very rarely, and represents a sudden and sharp decrease in granulocytes (a type of white blood cell) that can lead to serious or even fatal infections.
Metamizole-containing medicines are marketed in Montenegro under the name Analgin, manufactured by Alkaloid AD, and are available as tablets as well as in the form of a solution for injection. Analgin is authorised for treating pain and fever when other available medicines are not effective, and patients should be warned to stop using this medicine and inform their healthcare professional if they develop symptoms of agranulocytosis. These include fever, chills, sore throat and painful sores on the moist, inner body surfaces (mucosa), especially in the mouth, nose and throat or in the genital or anal regions. Symptoms of agranulocytosis may occur in the course of use of metamizole-containing medicines, or shortly after. When metamizole is used to treat fever or together with antibiotics, the early symptoms of agranulocytosis may be masked.
Information on metamizole-containing medicines will be updated to include new recommendations. In addition to Analgin, the medicine Pyreox (metamizole sodium) manufactured by ICN Polfa Rzeszów S.A. is also authorised in Montenegro, but is not on the market yet. The letter intended for healthcare professionals may be found on the portal in the section Pharmacovigilance/Direct Healthcare Professional Communication. No cases of suspected agranulocytosis related to the use of Analgin have been reported to the Institute of Medicines and Medical Devices. CInMED invites healthcare professionals and patients to report any suspected adverse reaction to a medicine using the online reporting form available here.
