TGA releases warning over Diane-35
The Therapeutic Goods Administration (TGA) has issued a public warning to health professionals and consumers over the contraceptive pill Diane-35 over fears that it may cause blood clots.
The French made drug is also available in Australia under the trade names Benda-35, Juliet-35, Estalle-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
The TGA is undertaking a review of the safety information available for Diane-35, and has announced it will provide updated advice when it completes the review.
The agency has urged customers to immediately contact their doctor or go to the Emergency Department of their nearest hospital if any of the symptoms of blood clots present themselves:
- persistent leg pain or tenderness
- swelling, warmth and redness of the leg
- severe chest pain
- sudden shortness of breath or difficulty breathing.