Beyaz/Safyral drospirenone/ethinyl estradiol/levomefolate calcium regulatory update

FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee will meet Dec. 8-9 to discuss the risk of blood clots with use of oral and transdermal contraceptives. On Dec. 8, the committees will discuss the potential increased risk of venous thromboembolism (VTE) with use of drospirenone-containing oral contraceptives. FDA said preliminary data from a FDA-funded epidemiologic study evaluating the risk suggest about a 1.5-fold increased risk of blood clots for drospirenone-containing oral contraceptives vs. other hormonal contraceptives. Marketed drospirenone-containing contraceptives include Bayer's Yaz/Yasmin drospirenone/ethinyl estradiol tablets and Beyaz/Safyral drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets. Drospirenone-containing contraceptives are available as generics. ...