New drug safety measures from EMA’s PRAC

The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to minimize 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 authorized in a number of European Union (EU) countries for treating moderate-to severe pain and fever. The authorized 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.

Agranulocytosis is a known side effect with metamizole-containing medicines that can occur at any time during treatment, or shortly after stopping the medicine, and in people who have used metamizole previously without problems.