The Medical Letter TML n. 21 / 2024
Nr. 21 del 14/10/2024
TML n. 21 / 2024 Nuova avvertenza per il fezolinetant
La US Food and Drug Administration (FDA) ha richiesto l'inserimento di una nuova avvertenza sull'etichetta della confezione dell'antagonista selettivo orale dei recettori della neurochinina 3 (NK3) fezolinetant (Veoza Astellas Pharma) sul rischio di epatossicità. (1,2) L'etichetta del fezolinetant, approvato dall'FDA nel 2023 per il trattamento dei sintomi vasomotori da moderati a gravi dovuti alla menopausa, conteneva già un'avvertenza sull'innalzamento delle transaminasi epatiche associato all'uso del farmaco.
La nuova avvertenza si basa su un singolo caso post marketing di danno epatico colestatico misto acuto indotto dal farmaco. La paziente ha presentato spossatezza, nausea, prurito, ittero, feci chiare, urine scure e livelli elevati di enzimi epatici e bilirubina totale entro 40 giorni dall'inizio del trattamento con fezolinetant.
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