Which is the destiny of ulipristal acetate for uterine fibroids? A commentary on the Italian medicines agency (AIFA) pronouncements

Recenti Prog Med. 2019 Feb;110(2):98-99. doi: 10.1701/3112.31006.

Abstract

The 19 of February 2018 the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco) temporary stopped the new administration of Ulipristal Acetate (UPA) for treating uterine leiomyomas symptoms, because liver injury and hepatic failure had been reported in relationship with UPA use. After the European Medicines Agency review of risks of UPA, the 3 of August 2018 the AIFA produced another note, disclosing that a cause-effect relationship between the UPA use and liver injury is not proved and that some patients can be discontinuously treated if surgery is not recommended. However, a close monitoring of hepatic function must be done in Ulipristal users. As Ulipristal has not been prescribed since February 2018 in our center, the rate of surgical operations for uterine leiomyomas significantly doubled. Therefore it will be useful know exactly which restricted indications allow to use UPA for more than 3 months. In this way it could be minimized the risks of liver injury and it could be prevented the rise of surgeries for uterine leiomyomas.

MeSH terms

  • Chemical and Drug Induced Liver Injury / etiology*
  • Chemical and Drug Induced Liver Injury / prevention & control
  • Contraceptive Agents, Female / administration & dosage
  • Contraceptive Agents, Female / adverse effects
  • Female
  • Humans
  • Italy
  • Leiomyoma / drug therapy*
  • Leiomyoma / surgery
  • Liver Function Tests
  • Norpregnadienes / administration & dosage*
  • Norpregnadienes / adverse effects
  • Time Factors
  • Uterine Neoplasms / drug therapy*
  • Uterine Neoplasms / surgery

Substances

  • Contraceptive Agents, Female
  • Norpregnadienes
  • ulipristal acetate