Diane 35, a common hormonal treatment for acne and also an effective oral contraceptive, has been banned in France after its apparent link to four deaths.
The move has prompted other medicine safety agencies including Australia's Therapeutic Goods Adminsitration (TGA) to re-examine the evidence.
The French National Agency for Medicines and Health Products Safety (ANSM) decided the added risk of venous thromboembolism in patients outweighed the benefits of the drug.
Diane 35, available in France since 1987, contained both a synthetic oestrogen and the anti-androgen cyproterone acetate. It was licensed in many countries around the world as a treatment for androgenic symptoms in women such as severe acne and excess facial or body hair.
All About Acne co-chair Associate Professor Kurt Gebauer said in Australia the drug was infrequently prescribed by dermatologists for the treatment of severe acne because it took longer to act than other acne medications.
He said Diane 35 was more commonly prescribed in general practice because it had the added benefit of being an effective oral contraceptive and helping to settle down menstrual problems.
The drug is also available in Australia as Brenda 35, Juliet 35, Estelle 35 and Laila 35.
“With any oral contraceptive, there needs to be a discussion around risk factors for thromboembolism. These include smoking, obesity, immobility and a family history of blood clots or strokes,” A/Professor Dr Gebauer said.
“France is certainly a different market to Australia – their higher rates of smoking may make the risk higher for French women.”
While the drug has been used in Australia for more than 20 years, he suggested women who are worried about their risk should talk to their doctor.
Women who are currently taking Diane 35 are warned not to stop the drug abruptly to avoid unnecessary side effects.