Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids

Abstract

Introduction: Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). SPRMs are a new class of progesterone-receptor ligands that exert tissue selective agonist, antagonist or mixed agonist–antagonist activity in target cells. UPA inhibits the proliferation, induces apoptosis of leiomyoma cells in vitro and demonstrates potent progesterone antagonist activity in vitro and in vivo.

Areas covered: This manuscript aims to review the available data on safety of UPA in the treatment of uterine fibroids. Data and articles included in this manuscript were obtained via PubMed, Medline and Embase up to November 2014.

Expert opinion: UPA is efficacious in the treatment of uterine fibroids before surgery; it decreases leiomyoma volume and uterine bleeding; furthermore, it improves quality of life. Short-term administration of UPA has been shown to be safe at short follow-up (months) and it is associated with minimal adverse side effects; further studies with longer follow-up are required to define the safety profile of UPA on endometrial histology.

Keywords:

• safety
• selective progesterone-receptor modulators
• tolerability
• treatment
• ulipristal acetate
• uterine fibroids

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.