[Metamizol: current status in Dutch practice]

Area of Science:

• Pharmacology
• Clinical Medicine
• Drug Safety

Background:

• Metamizole, a non-selective Nonsteroidal Anti-Inflammatory Drug (NSAID), offers strong analgesic and spasmolytic effects.
• Concerns regarding agranulocytosis led to its withdrawal in many countries since the 1970s.
• The absolute risk of metamizole-related agranulocytosis is exceptionally low, estimated below 1 per million daily doses.

Purpose of the Study:

• To re-evaluate the safety and potential for wider application of metamizole, particularly oral formulations.
• To address the ongoing debate surrounding metamizole's market presence in light of updated risk assessments.
• To highlight the need for a re-opened discussion on metamizole's use in the Netherlands.

Main Methods:

• Review of existing data on metamizole-associated agranulocytosis risk.
• Comparison of metamizole's safety profile with other NSAIDs regarding morbidity and mortality.
• Analysis of regulatory decisions and clinical practice in the Netherlands regarding metamizole.

Main Results:

• The absolute risk of metamizole-induced agranulocytosis is less than 1 per million daily doses.
• Agranulocytosis incidence can be mitigated through short-term use and careful patient selection.
• Metamizole demonstrates a favorable safety profile compared to other NSAIDs concerning morbidity and mortality.

Conclusions:

• The risk of agranulocytosis associated with metamizole is very low and manageable.
• Metamizole's favorable safety profile warrants a re-examination of its restricted use.
• The recent certification of an oral formulation in the Netherlands suggests a potential for broader application, necessitating further debate.