Australia’s Therapeutic Goods Administration (TGA) have issued a statement advising that they are closely monitoring the safety of acne drug and contraceptive pill Diane-35.Earlier this week French authorities called for a move to ban Diane-35 after blood clots and the deaths of four women over the past 25 years were linked to the drug. The European Medicines Agency also plans to conduct a Europe-wide review.
Diane-35 (also known as Brenda-35, Juliet-35, Estelle-35 and Laila-35 in Australia) is mostly prescribed to treat acne and hirstutism (a PCOS symptom) but also has a contraceptive effect.
France will suspend the marketing authorisation of the medicine with the next three months.
In Australia, the TGA are asking that consumers contact their doctor immediately if they develop symptoms of blood clots such as persistent leg pain or tenderness, swelling or redness of the leg, severe chest pain, shortness of breath or difficulty breathing.They will be undertaking a review of the drug and will provide updated advice once this is completed.
Warnings about the use of Diane-35, which is sold in 116 countries, and links to DVT, began to surface in the UK in 2001.
In 2003 Dr Eric Wooltorton, Associate Professor of the Canadian Medical Association Journal warned that due to these risks, “Diane-35 should be reserved for temporary use in women with serious acne and should not be used solely as an oral contraceptive.”
Diane-35 comes with a warning not to take it if you have a history of circulatory disorders or tumours. For more information contact the Therapeutic Goods Administration
*UPDATE: Since the publication of this news piece, Bayer has welcomed the European Commission's confirmation of positive decision on Diane-35. That is, that the benefits of Diane-35 outweigh the risks for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. In Australia, these products are authorised for the treatment of severe acne or idiopathic hirsutism of mild to moderate degree. In Australia, Diane-35 is not approved for use as a contraceptive.