[Thrombosis and embolism during Diane-35 use: analysis of reports made to the Netherlands Pharmacovigilance Centre Lareb]

Ned Tijdschr Geneeskd. 2014:158:A6651.
[Article in Dutch]

Abstract

After media attention on the possible risks of thromboembolic complications associated with the use of cyproterone/ethinylestradiol (Diane-35 and generics), the Netherlands Pharmacovigilance Centre Lareb received a large number of reports over a short period of time. We describe in detail the reports of serious undesirable effects, also taking into account the indication, time to onset and risk factors, identification of the complication, treatment and course. The reports Lareb received give an insight into the nature and impact of the occurrence of these adverse drug reactions in daily practice. It was mentioned that cyproterone/ethinylestradiol was often used as a contraceptive drug. Some reports mentioned the fact that thrombosis and embolism were not always recognised at an early stage by users.

MeSH terms

  • Androgen Antagonists / adverse effects*
  • Androgen Antagonists / therapeutic use
  • Cyproterone Acetate / adverse effects*
  • Cyproterone Acetate / therapeutic use
  • Drug Combinations
  • Drug-Related Side Effects and Adverse Reactions
  • Embolism / chemically induced*
  • Ethinyl Estradiol / adverse effects*
  • Ethinyl Estradiol / therapeutic use
  • Female
  • Humans
  • Male
  • Netherlands
  • Pharmacovigilance*
  • Risk Factors
  • Thrombosis / chemically induced*

Substances

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