Farmacovigilanza SIF > Sezioni > Safety News > Agenzie Internazionali > Rischio di rottura splenica atraumatica associata a trattamento con anticoagulanti orali. Ministero della Salute canadese 28 febbraio 2025

Rischio di rottura splenica atraumatica associata a trattamento con anticoagulanti orali. Ministero della Salute canadese 28 febbraio 2025

A cura di Alessandra Russo. Specialista in Tossicologia Medica. Messina

 

Il Ministero della Salute canadese ha pubblicato un avviso relativo al possibile rischio di rottura splenica atraumatica associata a trattamento con anticoagulanti orali (apixaban, dabigatran, edoxaban, rivaroxaban e warfarin).

 

Il Ministero della Salute canadese ha analizzato le informazioni disponibili presenti nel database canadese e nella letteratura scientifica.

 

In particolare, il Ministero della Salute canadese ha analizzato 42 casi (3 canadesi e 39 internazionali) di rottura splenica in pazienti in trattamento con anticoagulanti orali, inclusi casi pubblicati in letteratura (1-34).

 

  • Su 42 casi analizzati, la correlazione è risultata probabile in 1 caso, possibile in 21 casi (1 canadese) e improbabile in 16 casi. In 4 casi (2 canadesi) non è stato possibile effettuare la valutazione a causa della mancanza di informazioni.
  • In 9 casi su 21 possibili, non c’erano altre possibili spiegazioni (ad esempio traumi, altre patologie concomitanti).

 

Il Ministero della Salute canadese ha anche analizzato i risultati di uno studio in cui sono state esaminate 27.000 segnalazioni internazionali di sospette reazioni avverse a trattamento con anticoagulanti orali (35).

  • I risultati evidenziavano che gli eventi associati a rottura splenica erano riportati con maggiore frequenza rispetto a quanto atteso con questi farmaci.

 

Bibliografia

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Ultimo aggiornamento: 20 marzo 2025