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On 5 February 2013, the TGA published a safety advisory regarding Diane-35 (a combination product containing cyproterone acetate 2 mg with ethinyloestradiol 35 micrograms). This safety advisory included information about the increased risk of venous thromboembolism (VTE).
The TGA has since completed a review of the safety information available for products containing cyproterone with ethinyloestradiol.
The review has found that there is an increased risk of VTE in women using these products. However, it has been determined that the medicine's benefits continue to outweigh the risks when used for the indications approved by the TGA and outlined in the Product Information (PI).
Health professionals and consumers are reminded that products containing cyproterone with ethinyloestradiol should be used with caution in patients who have risk factors for VTE.
The TGA will continue to monitor this medicine and is working with the sponsor of Diane-35 to update the PI.
Further updated information is provided below in the 'Additional information' section.
Products containing cyproterone with ethinyloestradiol, such as Diane-35, are approved for the treatment of androgenisation in women, such as severe acne and hirsutism, and also provide contraceptive cover when used in this patient group.
Diane-35 is also available in Australia under the trade names Brenda-35, Juliet-35, Estelle-35 and Laila-35.
Information for consumers
If you are taking a product containing cyproterone with ethinyloestradiol, such as Diane-35, and have any questions or concerns, ask your health professional.
Do not stop taking a product containing cyproterone with ethinyloestradiol without consulting your doctor.
All hormonal products and oral contraceptives pose a small risk of blood clots. This risk is influenced by age, family history of blood clots and lifestyle factors, such as weight and smoking.
Contact your doctor immediately or go to the Emergency Department at your nearest hospital if you develop any symptoms of blood clots, such as:
- persistent leg pain or tenderness
- swelling, warmth and redness of the leg
- severe chest pain
- sudden shortness of breath or difficulty breathing.
Information for health professionals
Prescribers should be mindful of the contraindications and precautions outlined in the PI for Diane-35 and other products containing cyproterone with ethinyloestradiol, and should:
- weigh the clinical needs of their patients against the possible slight increase in the risk of VTE
- inform their patients about the increased risk of VTE
- educate their patients to recognise the signs and symptoms of VTE.
Additional information
In January 2013, the French medicines agency (ANSM) published information about its review of Diane-35. ANSM found that the risk of VTE outweighed the benefits of Diane-35 in treating acne and hirsutism.
However, on 17 May 2013, the European Medicines Agency announced that its Pharmacovigilance Risk Assessment Committee had concluded that the benefits of Diane 35 and its generics outweighed the risks, provided that several measures were taken to minimise the risk of VTE.
On the basis of published studies, the TGA has concluded that the risk of VTE with use of products containing cyproterone with ethinyloestradiol appears to be around 1.5 to 2 times higher than for combined oral contraceptives (COCs) containing the progesterone, levonorgestrel, and may be around 4 times the risk in non-users of COCs.
Nevertheless, bearing in mind the contraindications for this medicine, in absolute terms this risk is low, and is lower than the risk for pregnant and postpartum women.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine, vaccine or medical device.