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Combination Products containing Cyproterone Acetate 2mg and Ethinylestradiol 0.035mg: Restriction of Indication and Measures to Reduce Risk of Thromboembolism

Date: 14 May 2014

Description: NPCB would like to inform all healthcare professionals that a Safety Update Report [Ref: (1) dlm. BPFK/PASCA/FV/16] has been issued as above. Following a review of the benefit-risk profile of products containing the combination cyproterone acetate 2mg and ethinylestradiol 0.035mg, the indication of these products was tightened totreatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, these products should only be used after topical therapy or systemic antibiotic treatment has failed. Healthcare professionals are reminded that these products shouldnot be used for the sole purpose of contraception, but provide adequate contraceptive effect when used for the approved indications stated above. Several steps must be taken to minimise the risk of thromboembolism when prescribing these products.NPCB will continue to monitor the situation and requests all healthcare professionals to report any suspected ADR related to cyproterone acetate 2mg/ethinylestradiol 0.035mg to the National Centre for Adverse Drug Reactions Monitoring.

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