Finland banned metamizole drugs in 2024 for agranulocytosis risk, but Poland still sells them without prescription.
Finland’s Withdrawal
Finland withdrew medications containing metamizol, such as Litalgin, in summer 2024. The Finnish Medicines Agency (Fimea) ended permits due to the risk of agranulocytosis, making the drugs unavailable in Finnish pharmacies.
EMA’s Review
In June 2024, the European Medicines Agency (EMA) launched a safety review of metamizol under Article 107i. The EMA aimed to assess whether EU-wide usage rules needed changes. In September 2024, the EMA concluded, advising no universal ban but emphasizing safety measures.
Metamizol in Europe
Metamizol’s legal status varies across the EU. It is banned or never approved in countries like Finland, Germany, Spain, and the Czech Republic, where it is prescription-only. Other nations allow over-the-counter sales under specific regulations.
Metamizol in Poland
In Poland, metamizol (e.g., Pyralgin) remains available without prescription for decades. The Office for Registration of Medicinal Products (URPL) issued a safety alert in December 2024, reminding users of agranulocytosis risks and safe usage guidelines. No withdrawal has been announced.
Agranulocytosis Risks
Agranulocytosis involves a severe drop in neutrophils, leading to life-threatening infections. Symptoms include fever, sore throat, mouth ulcers, and weakness. Genetic factors like HLA may influence risk, though the mechanism isn’t fully understood.
Patient Safety
Patients in Poland can still access metamizol but must heed safety warnings. All painkillers, including paracetamol and ibuprofen, carry risks. Regulatory decisions reflect local data and benefit-risk assessments, not ignored dangers.
