The bitter pill

Cox, Lucy

doi:10.1136/jfprhc-2014-101015

Cited by 1 publication

(1 citation statement)

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“…Diane ® -35 [cyproterone acetate 2 mg/ethinylestradiol 35 µg (CPA/EE)], a combined estrogen/progestogen treatment with anti-androgenic properties, was first authorized in Europe in 1985 to treat androgenic conditions (i.e., acne, seborrhea, hirsutism, and alopecia) [ 1 ]. In 2013, the French National Agency for the Safety of Medicine and Health Products suspended the marketing of Diane ® -35 and its generics, having attributed 125 cases of thrombosis and four deaths to CPA/EE products during a review of 25 years of historical data in France [ 1 , 2 ]. The suspension of CPA/EE medications in France occurred in the midst of more general controversy over the use of third- and fourth-generation combined hormonal contraceptives [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Risk-Minimization Activities for Cyproterone Acetate 2 mg/Ethinylestradiol 35 µg: A Cross-Sectional Physician Survey

et al. 2017

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BackgroundCyproterone acetate 2 mg/ethinylestradiol 35 µg, an estrogen/progestogen treatment with anti-androgenic properties, shares a thromboembolism risk with combined hormonal contraceptives. Educational materials (i.e., direct healthcare professional communication, patient information card, prescriber checklist) were distributed to physicians to increase risk awareness.ObjectiveThe objective of this study was to measure physician knowledge of thromboembolism risk of cyproterone acetate 2 mg/ethinylestradiol 35 µg and ascertain whether physicians received the educational materials.MethodsA cross-sectional web-based physician survey of recent prescribers of cyproterone acetate 2 mg/ethinylestradiol 35 µg in Austria, the Czech Republic, France, the Netherlands, and Spain was conducted. Sampling targets for physician specialty were based on country-specific prescribing patterns. Frequency of correct responses was calculated for 14 knowledge questions.ResultsAmong 759 physician respondents (37% of obstetricians/gynecologists, 42% of general practitioners, 20% of dermatologists), 51% received one or more of three educational materials. Knowledge was highest (≥80%) for symptoms of possible deep vein thrombosis, pulmonary embolism, and cerebrovascular accident; most important risk factors for thrombosis; use in smokers; indication for moderate-to-severe acne; and understanding that cyproterone acetate 2 mg/ethinylestradiol 35 µg should not be used for contraception alone. Knowledge varied for contraindications, myocardial infarction symptoms, other risk factors for thrombosis, instructions regarding anticipated prolonged immobilization, and selected concomitant medical conditions. Knowledge was lower regarding prescribing cyproterone acetate 2 mg/ethinylestradiol 35 µg for acne only after failure of topical therapy or systemic antibiotics. Generally, knowledge did not vary by physician specialty, receipt of educational materials, number of patients prescribed cyproterone acetate 2 mg/ethinylestradiol 35 µg in the previous 3 months, and years in practice.ConclusionsKnowledge was generally high for thromboembolism risk and varied for more complex or infrequent topics.Electronic supplementary materialThe online version of this article (doi:10.1007/s40290-017-0203-9) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%