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Dianette (R)

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This a combined preparation of cyproterone acetate with ethinyloestradiol. It has anti-androgenic properties and may be helpful in women who require oral contraception and suffer from acne or hirsutism.

Features of dianette include (1)

  • dianette is essentially an oestrogen - dominant oral contraceptive pill and it carries with it an increased risk of venous thromboembolism similar to third - generation progestogens
  • there are also some additional concerns that cyproterone acetate may cause liver tumours (benign and malignant) based on animal studies, albeit with much higher doses. The dianette data sheet recommends that treatment is withdrawn when the acne has completely resolved. However it also states that repeat courses may be given if the condition recurs

The Committee on Safety of Medicines notes (2) that dianette is NOT authorised for the sole purpose of oral contraception and should be discontinued 3 to 4 menstrual cycles after the woman's androgen-related condition has completely resolved.

Prescriber are reminded that (2):

  • dianette is not indicated for use solely as an oral contraceptive
  • dianette is a treatment for women with severe acne that has not responded to oral antibiotics, or for moderately severe hirsutism
  • dianette should be withdrawn 3-4 cycles after the treated condition has completely resolved
  • the incidence of venous thromboembolism is higher than in women who use low-dose oestrogen COCs
  • dianette is contraindicated in women with a personal or close family history of confirmed, idiopathic venous thromboembolism and in those with a known current venous thrombotic or embolic disorders
  • women who have severe acne or hirsutism may have an inherently increased cardiovascular risk

Reference:

  1. Dermatology in practice (2001), 9 (2), 10-13.
  2. Current Problems in Pharmacovigilance (2002), 28, 9-10.

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