Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Metamizole-containing medicines - Direct communication with healthcare professionals on Metamizole-containing medicines

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Direct communication with healthcare professionals on Metamizole-containing medicines

Metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis.

Summary 

  • Patients treated with metamizole-containing medicines should be informed of the: 
    • early symptoms suggestive of agranulocytosis, including fever, chills, sore throat and painful mucosal changes, especially in the mouth, nose and throat or in the genital or anal region; 
    • need to remain vigilant for these symptoms as they may occur at any time during treatment, even shortly after treatment discontinuation; 
    • need to discontinue treatment and seek immediate medical attention if they develop these symptoms. 
  • If metamizole is taken for fever, some symptoms of emerging agranulocytosis may go unnoticed. Additionally, symptoms may also be masked in patients receiving antibiotic therapy. 
  • If agranulocytosis is suspected, a complete blood count (including differential blood count) should be performed immediately, and treatment must be stopped while waiting for the results. If confirmed, treatment must not be reintroduced. 
  • <Routine blood count monitoring of patients treated with metamizole-containing medicines is no longer recommended.> 
  • Metamizole is contraindicated in patients with a prior medical history of metamizole-induced agranulocytosis (or from other pyrazolones/pyrazolidines), impaired bone marrow function or diseases of the haematopoietic system.


Published on: 09 December 2024

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