The Medical Letter TML n. 8 / 2025
Nr. 08 del 14/04/2025
TML n. 8 / 2025 Modifiche alle schede tecniche dei farmaci a base di testosterone
La US Food and Drug Administration (FDA) ha richiesto di modificare le schede tecniche di tutti i prodotti a base di testosterone per riportare i nuovi dati sugli effetti cardiovascolari. Le schede tecniche aggiornate non conterranno più l'avvertenza relativa all'aumento del rischio di eventi cardiovascolari avversi, ma conterranno una nuova avvertenza relativa all'aumento della pressione sanguigna. (1)
TERAPIA DI SOSTITUZIONE DEL TESTOSTERONE – Tutti i sostituti del testosterone disponibili negli Stati Uniti sono stati approvati dalla FDA per il trattamento dei maschi con condizioni associate a una carenza o assenza di testosterone endogeno. Nessun prodotto a base di testosterone è approvato per il trattamento dei bassi livelli di testosterone dovuti esclusivamente all'invecchiamento.
STUDI CLINICI – Le modifiche alla scheda tecnica si basano sui risultati di uno studio in doppio cieco (TRAVERSE) e su studi di monitoraggio ambulatoriale della pressione arteriosa successivi alla commercializzazione.
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