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Agenzia Italiana del Farmaco
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole - EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
On 18 September 2024, the CMDh endorsed the measures recommended by EMA’s safety committee, PRAC, to minimise the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole. Agranulocytosis involves a sudden and sharp decrease in granulocytes, a type of white blood cell, that can lead to serious or even fatal infections.
Product information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosis.
The committee recommended that healthcare professionals must inform patients to stop taking these medicines and seek immediate medical attention if they develop symptoms of agranulocytosis.
Published on: 20 September 2024
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