Reduction in use of cyproterone/ethinylestradiol (Diane-35 and generics) after risk minimization measures in the Netherlands, UK and Italy

Contraception. 2020 Oct;102(4):243-245. doi: 10.1016/j.contraception.2020.05.010. Epub 2020 May 26.

Abstract

Objectives: To study the effect of risk minimization measures taken in 2013 for cyproterone acetate/ethinylestradiol (CPA/EE) on initiation, concomitant use of other hormonal contraceptives (HC) and potential indications.

Study design: This retrospective study included data on CPA/EE use in 2011-2017 from the Netherlands, UK, and Italy.

Results: The initiation rate of CPA/EE decreased by 44%-91% between 2011 and 2017. Proportions with concomitant use of other HC (<3%) and approved indications did not change over time.

Conclusion: Apart from a strong reduction in CPA/EE use following risk minimization measures, no major changes were observed regarding concomitant use of other HC or potential reasons for use.

Keywords: Acne; Cyproterone acetate/ethinylestradiol; Diane-35; Prescribing; Real world data; Risk minimization.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acne Vulgaris*
  • Cyproterone
  • Cyproterone Acetate / administration & dosage*
  • Drug Combinations
  • Ethinyl Estradiol / administration & dosage*
  • Humans
  • Italien
  • Niederlande
  • Retrospective Studies
  • Vereinigtes Königreich

Substances

  • Drug Combinations
  • Ethinyl Estradiol
  • Cyproterone Acetate
  • Cyproterone acetate, ethinyl estradiol drug combination
  • Cyproterone