Blood Clot Alert on Contraceptive Pill Ban
The Therapeutic Goods Administration has issued a safety alert on the acne drug Diane 35, days after French authorities banned it because of links to four deaths from blood clots in the past 25 years.
France's National Agency for the Safety of Drugs and Health Products said this week that Diane-35, made by Bayer and licensed in 135 countries, would be withdrawn from sale in three months.
Meanwhile, doctors are banned from prescribing the medication.
The TGA says it is undertaking a review of the safety information available for Diane 35.
The medicine is approved for treating acne and hirsuitism in Australia, but it also acts as a contraceptive pill.
It is also available in Australia under the trade names Brenda 35, Juliet 35, Estelle 35 and Laila 35.
The TGA said the French medicines agency (ANSM) had reviewed Diane-35 and found that the risk of venous thromboembolism (blood clots) outweighs the benefits of Diane-35 in treating acne and hirsutism.
The European Medicines Agency is also planning to conduct a review of the medicine.
Women using the medicine should consult their doctor immediately if they develop any symptoms of blood clots, such as persistent leg pain or tenderness, swelling, warmth and redness of the leg, severe chest pain or sudden shortness of breath or difficulty breathing, the TGA says.
“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,” the TGA says.
Drug company Bayer, which makes Diane-35, said it took product safety “very seriously”.