(2003; 14 pages)
CYPROTERONE ACETATE & ETHINYL-ESTRADIOL - Update on risk of venous thromboembolism
Canada. The combination product of cyproterone and ethinylestradiaol (Diane-35) is prescribed in the treatment of androgen related conditions such as severe acne or hirsutism in women. As with all estrogen/progestogen combination products, the combination of cyproterone and ethinyl-estradiol (Diane-35) is associated with an increased risk of venous thromboembolism. This product is therefore contraindicated in women with thrombophlebitis, thromboembolic disorders or a history of these conditions. Some published studies suggest that users of this combination product (Diane-35) may have an elevated risk of venous thromboembolic events compared to users of combination oral contraceptives. The combination of cyproterone and ethinylestradiol (Diane-35) should not be prescribed for the sole purpose of contraception. And, during treatment with this combination, other oral contraceptives should not be used. This information has been sent to all healthcare professionals by Berlex Canada Inc, in consultation with Health Canada.
Reports in WHO-file: Thromboembolism 3, thrombosis 43
‘Dear Healthcare Professional’ letter from Berlex Canada Inc, 10 Apr 2003. Available from URL: http://www.hc-sc.gc.ca