Safety warning on contraceptive pill Diane-35

February 6, 2013, 1:02 pm Sarah McCarthy Women's Health

After the French government moved to ban sales of Diane-35, the TGA has issued their own safety warning.

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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.

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  1. Margo05:14am Sunday 05th May 2013 ESTReport Abuse

    I used this pill prescribed by a dermatologist, after a month no improvement on acne, but two blue spots on the leg. I went to a gynecologist. My granny died from blood cloth by the way. Knowing this she advised to continue using it a few months more and come for a check if don't feel well. Thanks God I stopped it on my own. what are doctors thinking? You go to get rid of a spot and they offer you killer-drugs??!!!!

  2. Teresa05:28pm Thursday 07th February 2013 ESTReport Abuse

    totally disgraceful that they could let this happen to consumers that needed this medication for serious issues, putting people in a bad position.

    3 Replies
  3. Adam02:49am Thursday 07th February 2013 ESTReport Abuse

    Why was my honest and well researched comment removed, yet a very abusive comment allowed to stay?

  4. Steve B12:57am Thursday 07th February 2013 ESTReport Abuse

    An acne/contraceptive pill? Makes you wonder why.

    4 Replies
  5. YeanL09:08pm Wednesday 06th February 2013 ESTReport Abuse

    Not surprised pharmaceuticals are in the top 5 leading causes of death! thats not including overdoses or misuse!

  6. YeanL09:05pm Wednesday 06th February 2013 ESTReport Abuse


  7. 08:57pm Wednesday 06th February 2013 ESTReport Abuse

    Jules Gillard you have serious issues. How sad that you are filled with so much hatred, and feel the need to post about it on a post about contraceptive. Sad and pathetic.

  8. Glib02:08pm Wednesday 06th February 2013 ESTReport Abuse

    Wow; I'm really glad I saw a picture of the pills.

    1 Reply

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