Safety Advisory


Further to Drugline Volume 205, HPS Pharmacies wish to advise that the TGA have completed a review of medicines containing ethinyloestradiol + cyproterone acetate (Diane-35®, Brenda-35®, Juliet-35®, Estelle-35®, and Laila-35®).

The review findings are in line with the European Medicines Agency that the risk of venous thromboembolism (VTE) is up to double that of patients taking other combined oral contraceptives, and four times higher than those who don’t take any. It was however affirmed that the absolute risks are low overall, and outweighed by the benefits when used according to the indications and product information.

In Australia ethinyloestradiol + cyproterone acetate is indicated for treatment of the symptoms of androgenisation in women such as acne and hirsutism. They also offer contraceptive cover to these patients.

Prescribers should always consider the risk/benefit ratio for each patient, inform them of the risks, and educate them to recognise and manage any signs of VTE.

Patients should discuss any concerns with their doctor before making a decision to discontinue these medicines.

Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please do not hesitate to contact your pharmacist at HPS Pharmacies.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

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