Safety advisory issued on Diane-35

THE Therapeutic Good Administration (TGA) has issued a safety advisory on Diane-35 and its generics after the French medicines agency (ANSM) made moves to ban it.

ANSM will suspend the marketing authorisation on Diane-35 in the next three months after it found the risk of blood clots outweighed the drug's benefits. The European Medicines Agency also plans to conduct a Europe-wide review.

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

The TGA advises if you are taking Diane-35 and have any questions or concerns, you should consult your health professional. Do not stop taking Diane-35 ED without consulting your doctor.

The TGA said 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.