WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) View the PDF document
Table of Contents
Open this folder and view contentsREGULATORY MATTERS
Close this folderSAFETY OF MEDICINES
View the documentANTIRETRO-VIRALS - Benefit/Risk balance remains strongly positive for combination antiretroviral therapy
View the documentCYPROTERONE ACETATE & ETHINYL-ESTRADIOL - Update on risk of venous thromboembolism
View the documentDIETHYL-STILBESTROL - Gynaecological and obstetric complications after in utero exposure
View the documentEPHEDRA - Moves to reduce risks of ephedra-containing products
View the documentFLUTICASONE PROPIONATE - Reports of adrenal crisis
View the documentGRAPEFRUIT JUICE - Revised advice from ADRAC
View the documentHORMONE REPLACEMENT THERAPY (HRT) - Risk of dementia
View the documentOMEPRAZOLE, RABEPRAZOLE - Reports of interstitial nephritis
View the documentROFECOXIB, CELECOXIB - Case reports support causal association with liver toxicity
View the documentROSIGLITA-ZONE, PIOGLITAZONE - Adverse reactions update
View the documentSOMATROPIN - Not to be authorized for AIDS-related wasting syndrome
Open this folder and view contentsCURRENT CONCERNS
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
 

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

Reference:
‘Dear Healthcare Professional’ letter from Berlex Canada Inc, 10 Apr 2003. Available from URL: http://www.hc-sc.gc.ca

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