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Diane-35

Safety advisory

5 February 2013

Health professionals and consumers are advised that the TGA is continuing to closely monitor Diane-35 and its generics.

Diane-35 is an anti-androgenic progestogen-oestrogen combination, which is approved for the treatment of signs of androgenisation (increased male hormones) in women, such as severe acne and hirsutism (excessive hairiness). It is also an effective oral contraceptive in these patients.

Diane-35 is also available in Australia under the trade names Brenda-35, Juliet-35, Estelle-35 and Laila-35.

The TGA is aware that the French medicines agency (ANSM) has reviewed Diane-35 and has announced that it will suspend the marketing authorisation of the medicine within the next three months. ANSM has found that the risk of venous thromboembolism (VTE, also known as blood clots) outweighs the benefits of Diane-35 in treating acne and hirsutism. The European Medicines Agency also plans to conduct a Europe-wide review.

The TGA is undertaking a review of the safety information available for Diane-35. Once this review has been completed, the TGA will provide updated advice.

Information for consumers

If you are taking Diane-35 ED and have any questions or concerns, ask your health professional.

Do not stop taking Diane-35 ED without consulting your doctor.

All oral contraceptives and other hormonal products, such as Diane-35, 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

Health professionals are reminded that, while Diane-35 has a contraceptive effect, it is not approved for that use in Australia.

Health professionals should be mindful of the contraindications and precautions outlined in the Diane-35 Product Information.

Health professionals should weigh the clinical needs of their patients against the possible slight increase in the risk of VTE, should inform their patients about the increased risk of VTE and educate their patients to recognise the signs and symptoms of VTE.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines, vaccines or medical devices. 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.