SAFETY ALERT: Possible Increased Risk of VTE with Drospirenone-Containing Contraceptives

The FDA has notified healthcare practitioners and patients that it is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. These two new studies reported that there is a 2–3 times greater risk of VTE associated with birth control pills that contain drospirenone. Because other studies have not reported an increase in risk, the FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. Patients currently taking oral contraceptives containing drospirenone should not stop taking it without consulting their healthcare provider.

Oral contraceptives that include drospirenone include Bayer's Yasmin and Yaz, Gianvi (Teva), Loryna (Sandoz), Ocella (Barr), Syeda (Sandoz), and Zarah (Watson) (drospirenone and ethinyl estradiol) and Bayer's Beyaz and Safyral (drospirenone, ethinyl estradiol and levomefolate calcium).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm257337.htm.