EMA Initiates Review of Painkiller Metamizole

The European Medicines Agency (EMA) has commenced a review of medications containing the painkiller metamizole due to concerns regarding the effectiveness of current measures in minimizing the risk of agranulocytosis.

Concerns and Authorizations

Metamizole-based medicines are authorized across several EU countries for managing moderate to severe pain and fever, with varying approved uses ranging from post-surgery pain treatment to cancer-related pain management.

Agranulocytosis, characterized by a sudden decrease in white blood cell levels, is a known side effect of these medicines, potentially leading to severe and even fatal infections. Current product information lists agranulocytosis as a rare or very rare side effect, with risk minimization measures differing among countries.

Reason for Review

The review was prompted by the Finnish medicines agency due to ongoing reports of agranulocytosis cases despite reinforced risk minimization measures in Finland. The company marketing the sole metamizole-containing medicine in Finland has requested withdrawal of its marketing authorization for safety reasons following recent agranulocytosis cases.

Review Process

EMA’s safety committee (PRAC) will assess the risk of agranulocytosis associated with all metamizole-containing medicines authorized in the EU. The review will evaluate existing risk minimization measures and their impact on the benefit-risk balance of these medicines. Recommendations will be made regarding the maintenance, variation, suspension, or revocation of marketing authorizations across the EU.

About Metamizole

Metamizole, also known as dipyrone, is an analgesic medicine used since the 1920s to treat moderate to severe pain and fever via oral, suppository, or injection administration. The review encompasses medicines containing metamizole alone or in combination with other active substances.

Review Procedure

Initiated by the Finnish medicines agency under Article 107i of Directive 2001/83/EC, the review is conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for adoption, ensuring harmonized safety standards for nationally authorized medicines across the EU.

Highlights:

• EMA starts review of metamizole-containing medicines due to concerns over agranulocytosis risk.
• Metamizole is authorized in EU countries for pain and fever, with varying approved uses.
• Agranulocytosis, a known side effect, prompts review following ongoing cases.
• PRAC will assess risk and recommend actions regarding marketing authorizations.
• Review includes metamizole alone or in combination with other substances, aiming for harmonized safety standards across the EU.