Yaz, Gianvi, Loryna, Yasmin, Ocella, Syeda, Zarah, Beyaz and Safyral and Blood Clot Risk

The FDA has issued a press release stating 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. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel:

Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. British Medical Journal (BMJ) 2011; 340:d2139.

Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011; 340 :d2151.

These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk.

Brand names of drospirenone-containing products include the following:

Yaz manufactured by Bayer HealthCare Pharmaceuticals Inc.

Gianvi (Yaz generic) manufactured by TEVA Pharmaceuticals USA Inc.

Loryna (Yaz generic) manufactured by Sandoz, Inc.

Yasmin manufactured by Bayer HealthCare Pharmaceuticals Inc.

Ocella (Yasmin generic) manufactured by Teva Pharmaceutical Industries Ltd.

Syeda (Yasmin generic) manufactured by Sandoz, Inc.

Zarah (Yasmin generic) manufactured by Watson Pharma, Inc.

Beyaz manufactured by Bayer HealthCare Pharmaceuticals Inc.

Safyral manufactured by Bayer HealthCare Pharmaceuticals Inc.

What is Drospirenone?

Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones–estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy.

Most birth control pills (combination oral contraceptives) combine a synthetic version of the female hormone progesterone (referred to as a progestin) with a synthetic version of the female hormone estrogen. Drospirenone is one of several different progestins that are used in birth control pills.

What is Deep Vein Thrombosis (DVT) and Pulmonary Emolus (PE)?

Deep vein thrombosis (DVT) is a rare but serious condition where a blood clot forms inside a vein. These blood clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs. If the clot travels to the lung, it is called a pulmonary embolism (PE), a potentially fatal condition where an artery in the lung becomes blocked.³ DVTs and PEs are also called venous thromboembolic events, or VTEs.

The symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain, and sudden shortness of breath. Women experiencing these symptoms should contact a healthcare professional immediately because VTEs can be life-threatening.