A strong decrease in the use of cyproterone acetate (CPA) 2 mg, in combination with ethinylestradiol (EE) 35 mcg (CPA/EE, available as Diane-35 or generic) was observed after risk minimization measures were implemented because of the increased risk of thrombotic events. The overall prevalence of users in the population in 2014 was one third of the prevalence in 2011, and the proportion of new users was one fifth. Although the risk minimization was targeted to reducing the amount of off-label use, no evidence was found for more on-label prescribing compared to the period before the risk minimization.
This was concluded in a study recently published in Pharmacoepidemiology and drug safety. In this study the effect of risk minimization measures on CPA/EE use were evaluated, using the PHARMO Database Network. Findings suggest that the risk minimization in Dutch healthcare was mainly through limiting the overall use of CPA/EE, mostly triggered by the negative advise of the Dutch Medicines Evaluation Board and media attention.
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