Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024

Review of painkiller metamizole started

Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it.

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.

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.

Agranulocytosis is a known side effect of metamizole-containing medicines. It involves a sudden and sharp drop in a type of white blood cell called neutrophils. This can lead to serious infections which can be fatal. It is listed as a rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side effect in the product information of the various authorised products. Measures to minimise this risk vary across countries…