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

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 report...

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Bibliographic Details
Published inNederlands tijdschrift voor geneeskunde Vol. 158; p. A6651
Main Authors van Hunsel, Florence P A M, Kant, Agnes C, van Puijenbroek, Eugène P
Format Journal Article
LanguageDutch
Published Netherlands 2014
Subjects
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
Netherlands
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Summary: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.
ISSN:0028-2162
1876-8784