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Safety Label Changes – April 2010
The FDA Center for Drug Evaluation and Research (CDER) approves an initial “safety labeling change” focused on the relative risks of thromboembolism (see box) and other vascular problems with taking drospirenone-containing combination oral contraceptives, such as Yaz vs. birth control pills containing levonorgestrel. 1
FDA Reviews of Yaz – May through Oct. 2011
In May 2011, the FDA announced that as part of its continued monitoring of birth control methods, it was reviewing combined oral contraceptives (including Yaz) that contain drospirenone, a synthetic hormone similar to progesterone. Acknowledging that all birth control pills may increase the likelihood of blood clots, the agency was concerned about several conflicting studies that indicated birth control pills with drospirenone may be more dangerous than other forms of contraceptive. 2
In October 2011, the FDA published a safety alert with its findings. Specifically, the FDA expressed concern that women who take these drugs may experience venous thromboembolism events (VTE) — that is, blood clots — such as deep vein thrombosis (DVT). The FDA’s alert came after reviewing two studies that indicated women who take birth control pills with drospirenone may be two or three times as likely to develop VTEs as those who use other forms of contraception containing levonorgestrel.
Although the FDA did not recall Yaz based on its review of these studies, the agency did urge women to discuss the possible effects of Yaz and other drospirenone-dependent drugs with their doctor. 3
Yaz VTE Update
In Spring 2012, the FDA issued further labeling changes specific to combined oral contraceptives that contain drospirenone. According to the FDA, “drospirenone-containing [birth control pills] may be associated with a higher risk of venous thromboembolism (VTE)” than contraceptives containing levonorgestrel or other progestins.
The risk of VTE is highest during the first year of use. Physicians were instructed to counsel patients about the information regarding the risk of VTE with drospirenone-containing COCs compared to COCs that contain levonorgestrel or some other progestins.4
- U.S. Food & Drug Administration. “Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets.” (May 14, 2012) Accessed Oct. 22, 2014. https://www.fda.gov/
- U.S. Food & Drug Administration. “FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone.” (May 31, 2011). Accessed Oct. 22, 2014. https://www.fda.gov/
- U.S. Food & Drug Administration. “Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots.” (Jan. 30, 2014). Accessed Oct. 22, 2014. https://www.fda.gov/
- U.S. Food & Drug Administration. “Yaz (drospirenone/ethinyl estradiol) tablets.” (May 23, 2012). Accessed Oct. 22, 2014. https://www.fda.gov/