FDA Changes Labeling on Drospirenone Birth Control and Blood Clots

Washington, DCThe Food and Drug Administration (FDA) announced today that it is revising the labels for drospirenone-containing birth control pills, warning of the higher associated risk for blot clots.

The change results from a newly completed review by the FDA of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, 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.

Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

Drospirenone, in combination with ethinyl estradiol, is used as an oral contraceptive in brand names such as Yasmin, Yaz and Safyral, (all made by Bayer) and Ocella, the generic brand of Yasmin (marketed and distributed by Barr Laboratories). These birth control pills, known as “fourth generation” contraceptive pills, have also been used to treat the symptoms of menopause, moderate acne and osteoporosis.

The revised drug labels will report that some epidemiologic studies showed 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.

The following contraceptives contain drospirenone: Yaz: Yasmin; Ocella; Safyral; Syeda; Zarah; Beyaz; Gianvi; and Loryna.