The European Medicines Agency (EMA) has started a review of medicines containing painkillers such as metamizole following concerns that the measures in place to minimize the known risk of agranulocytosis may not be effective enough. Metamizole-containing medicines are authorized in several European Union (EU) countries for treating moderate to severe pain and fever, with uses varying by country. Agranulocytosis, a known side effect, involves a sudden decrease in white blood cell levels, leading to serious and potentially fatal infections. The product information lists agranulocytosis as a rare or very rare side effect, and measures to minimize this risk differ across countries.
The review began at the request of the Finnish medicine agency due to continued reports of agranulocytosis despite strengthened risk minimization measures in Finland. Recently, the company marketing the only metamizole-containing medicine in Finland requested the withdrawal of its marketing authorization for safety reasons. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), will now review the risk of agranulocytosis for all metamizole-containing medicines in the EU, assessing their benefit-risk balance and recommending whether their marketing authorizations should be maintained, varied, suspended, or revoked.
Stakeholders, including healthcare professionals, patients’ organizations, and the public, are invited to submit data relevant to this review via the EMA website. This input will be crucial for the comprehensive assessment of metamizole’s safety profile. Engaging a broad range of stakeholders ensures that diverse perspectives and experiences are considered in the evaluation process, which is vital for making informed decisions about the safety and efficacy of these medicines.
Review Initiated for Metamizole-Containing Medicines Across EU Due to Safety Concerns
Metamizole, also known as dipyrone, is an analgesic used in the EU since the 1920s to treat moderate to severe pain and fever. It can be taken orally, as a suppository, or by injection. The review includes both medicine containing metamizole alone and in combination with other active substances. Metamizole-containing medicines are authorized in many EU countries under various names, including Afexil, Algifen, Algopyrin, Metamizol, Novalgin, and Tempalgin. However, in Finland, the only authorized metamizole-containing medicine is being withdrawn due to safety concerns.
The review of metamizole-containing medicine has been initiated under Article 107i of Directive 2001/83/EC at the request of the Finnish medicines agency. The PRAC is conducting the evaluation of safety issues for these medicines and will make recommendations. Since metamizole-containing medicines are authorized nationally, the PRAC’s recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The CMDh, representing EU Member States, Iceland, Liechtenstein, and Norway, will adopt a position to ensure harmonized safety standards for these medicines across the EU.
EMA Review Aims to Harmonize Safety Measures for Metamizole-Containing Medicines
Agranulocytosis, the main concern in this review, can lead to life-threatening infections due to the severe reduction in granulocytes, which are essential for fighting infections. The variability in risk minimization measures across different countries has prompted the need for a unified approach to ensure patient safety. By harmonizing these measures, the EMA aims to provide consistent protection for all patients using metamizole-containing medicines throughout the EU.
The comprehensive review will also consider the historical use and benefits of metamizole, which has been a valuable pain management option for many patients over the decades. Balancing these benefits against the risks is crucial for maintaining access to effective treatments while ensuring safety. The EMA’s review process will include an in-depth analysis of all available data, including clinical trial results, real-world evidence, and stakeholder input.
This initiative underscores the EMA’s commitment to safeguarding public health by continuously monitoring and evaluating the safety of medicines on the market. The outcome of this review could lead to significant changes in the way metamizole-containing medicine are prescribed and monitored, potentially setting new standards for pain management therapies in the EU.
Resource: European Medicines Agency, June 14, 2024
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