French Watchdog Pulls Bayer Acne Drug Over Clotting Risk

Law360, New York (January 30, 2013, 3:20 PM EST) -- France’s drug watchdog on Wednesday halted sales of Bayer AG’s acne drug Diane 35, citing risks of blood clots and a concern that its effectiveness as a contraceptive, for which it is also used, has not been demonstrated by appropriate clinical studies.

The National Agency for the Safety of Drugs and Health Products (ANSM) said it has estimated that the risk-benefit ratio of Diane 35 and its generic form is unfavorable in the treatment of acne, especially in view of the risk of venous thromboembolism, or...
To view the full article, register now.