What does non-eligibility for myoma surgery mean in the context of sequential prescription of ulipristal acetate?

Abstract

Ulipristal Acetate (UPA) is the only selective progesterone receptor modulator currently approved for medical management of myomas. Following several cases of liver toxicity during UPA treatment, new recommendations of PRAC (Pharmacovigilance Risk Assessment Committee) and EMA (European Medicines Agency) have been proposed, including a pre-therapeutic assessment of liver function and a close monitoring during treatment. Repeated courses of UPA have also been restricted to women who are defined as "non-eligible" for surgery. This article raises important questions and tries to provide clarification about the concept of 'non-eligibility' for myoma surgery.

Keywords: Fibroids; Non-eligibility for surgery; Ulipristal acetate.