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Important safety concerns on the use of Cyproterone Acetate and Ethinylestradiol

The National Medicines Regulatory Authority wishes to draw your attention to recent reviews on the safety of combination product Cyproterone Acetate and Ethinylestradiol.

Serious adverse thromboembolic events have been reported from France following extensive off-label use of Cyproterone Acetate 2mg and Ethinylestradiol 35mcg Tablets (Diane 35 and its generic products). At the request of the French National Agency of Medicines and Health Products Safety (ANSM), Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA) has reviewed the safety of the product and had concluded that the benefits of the drug outweigh the risks provided that several measures are taken to minimize the risk of thromoembolism.

The following brands and branded-generics are currently authorized for marketing in Sri Lanka

  • DIANE 35 manufactured by Bayer Schering Pharma AG, Germany and marketed by Hemas Pharmaceuticals (Pvt.) Ltd
  • GIANE 35 manufactured by Renata Ltd, Bangladesh and marketed by Emerchemie NB (Ceylon) Ltd
  • ESSTELLE 35 manufactured by Douglas Pharmaceuticals, New Zealand and marketed by Farnell Ceylon (Pvt) Ltd
  • TINA manufactured by Biolab Co Ltd, Thailand and marketed by George Steuart Health (Pvt) Ltd

Information to healthcare professionals

  • Cyproterone Acetate 2mg and Ethinylestradiol 35mcg Tablet is not authorized for the sole purpose of oral contraception
  • Cyproterone Acetate 2mg and Ethinylestradiol 35mcg Tablet should only be used for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
  • For the treatment of acne, these medicines should only be used only if topical therapy or systemic antibiotic treatment has failed.
  • Since these medicines act as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives. They should be discontinued 3 to 4 menstrual cycles after the androgen-related condition has completely resolved. Concomitant use with another hormonal contraceptive will expose women to a higher dose of oestrogen and increases the risk of thromoembolism.
  • Cyproterone Acetate and Ethinylestradiol 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 disorder.
  • Women who have severe acne or hirsutism may have an inherent increased cardiovascular risk.
  • Doctors should review patients on Cyproterone Acetate and Ethinylestradiol in line with these recommendations at their next scheduled appointment
  • Healthcare professionals should discuss with their patients the risk of thromoembolism and risk factors such as increasing age, smoking, obesity, and prolonged immobility. Patients should be educated to recognize signs and symptoms of venous thromoembolism.

References: – News and Events – Safety Information - Important Safety Information about Diane®35

Compiled by: Arjuna Pathmaperuma, Pharmacist/National Medicines Regulatory
Authority of Sri Lanka

120, Norris Canal Road, Colombo 10