Following publicity about medicines containing ethinyloestradiol + cyproterone acetate (DIANE-35, BRENDA-35, JULIET-35, ESTELLE-35 and LAILA-35), the Therapeutic Goods Association (TGA) has reminded us of its independence in deciding how and when drugs should be available in Australia, and that it does keep in touch with similar agencies in other developed countries.
Ethinyloestradiol + cyproterone acetate products will shortly lose marketing approval in France following at least four, and possibly seven deaths, from thrombosis. The decision by the French National Agency of Medicine and Health Products Safety (ANSM) was taken swiftly following its creation last year, after its predecessor had lost trust through a culture of permissiveness that may have caused hundreds of deaths from delayed action on safety issues with other products; and compounded by its financial dependence on the drug industry.
In Australia ethinyloestradiol + cyproterone acetate is for treatment of the symptoms of androgenisation in women such as acne and hirsutism. It may also be prescribed off-label for its contraceptive effect. The contraindications and precautions of the Product Information discuss the well known, but slight, increased risk of thrombotic events. Of Australia’s 129 reports describing 244 adverse events since 1993, none have reported a death, and 13 were related to venous thrombosis.
Both the TGA and the European Medicines Agency (EMA) are now reviewing if the risk of venous and arterial thromboembolism (VTE and ATE) outweighs the benefits of these medicines, and we are advised to act conservatively until the results are published.