SAFETY ALERT: Higher Blood Clot Risk with Drospirenone-Containing Contraceptives

After review of recent observational studies, the FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. Information about the studies will be added to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

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 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm.