EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole
Product information to be updated to raise awareness of known risk of agranulocytosis and facilitate its early detection and diagnosis
EMA’s safety committee (PRAC) has recommended measures 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.
Metamizole-containing medicines are authorised in a number of EU countries for treating moderate-to severe pain and fever. The authorised uses vary from country to country, ranging from the treatment of pain following surgery or injuries to the treatment of cancer-related pain and fever.
