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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
8 Comments
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??!!!!
Replytotally disgraceful that they could let this happen to consumers that needed this medication for serious issues, putting people in a bad position.
3 RepliesWhy was my honest and well researched comment removed, yet a very abusive comment allowed to stay?
ReplyAn acne/contraceptive pill? Makes you wonder why.
4 RepliesNot surprised pharmaceuticals are in the top 5 leading causes of death! thats not including overdoses or misuse!
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