January 30, 2013
PARIS (Deutsche Presse-Agentur) -- France on Wednesday announced the suspension of a popular acne drug commonly used as a contraceptive pill after it was found to have caused four deaths.
The National Agency for the Safety of Drugs and Health Products (ANSM) said that Diane 35, which is made by German company Bayer and licensed in 135 countries, would be withdrawn from sale in three months.
In the meantime, doctors are banned from prescribing it.
Over 300,000 French women are on Diane 35.
It is licensed only for the treatment of acne but doctors have also been prescribing it as a contraceptive because it stops ovulation.
Diane 35 has been linked to four deaths caused by clotting since it went on sale in France in 1987.
The ANSM said the risk of venous thromboembolism (blood clots in veins) was four times greater in patients who received the drug compared with those who did not.
The agency warned users against "abruptly halting their treatment" and advised them to consult with a doctor about alternatives.
Copyright 2013 dpa Deutsche Presse-Agentur GmbH