The Medical Letter TML n. 8/2011
Nr. 08 del 15/04/2011
TML n. 8/2011 – IN BREVE: Warning della FDA sul dronedarone
La FDA e il produttore del farmaco hanno avvertito i professionisti del settore sanitario che l’impiego del dronedarone (Multaq-Sanofi-Aventis), un analogo dell’amiodarone (Cordarone-Sanofi-Aventis, e altri; disponibile anche come medicinale equivalente) approvato nel 2009 per il trattamento della fibrillazione atriale (1, 2), è stato associato a “diversi” casi di grave danno epatico e di insufficienza epatica, compresi due casi nei quali si è reso necessario un trapianto di fegato. I due trapianti sono stati effettuati in donne di circa 70 anni di età; una aveva assunto il farmaco per 4,5 mesi e l’altra per 6 mesi. Secondo i dati forniti dalla FDA, negli Stati Uniti 147.000 pazienti sono stati trattati con dronedarone (3).
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