Study Confirms Birth Control Pills with Drospirenone, Other New Progestins, More Likely to Cause Blood Clots

A new study in the British Medical Journal confirms that birth control pills containing newer, synthetic progestins – such as <"">Yaz and Yasmin, which are made with drospirenone – pose an increased risk of blood clots compared to other pills. In fact, the study found that oral contraceptives made with the progestins drospirenone, desogestrel, or gestodene double the risk of blood clots compared to those made with levonorgestrel, an older progestin.

The British Medical Journal study was conducted by researchers at the University of Copenhagen in Denmark, who reviewed data of the hormonal contraception patterns and first time venous thromboembolism (VTE) episodes for all Danish non-pregnant women between the ages of 15 and 49 from January 2001 until December 2009. According to a press release announcing the study results, the participants had no previous record of either blood clots or cancer before the study began.

Among more than 8 million women observed during the study period, there were 4,246 first episodes of VTE. The study found that compared with women not using hormonal contraception, the relative risk of suffering a blood clot increased sixfold among women taking birth control pills with drospirenone, gestodene or desogestrel. Among women taking a pill with levonorgestrel, the risk only increased by threefold.

According to the study authors, the risk of VTE in current users of newer pills is about 10 per 10,000 women years. This means that about 2,000 women should shift from using oral contraceptives with desogestrel, gestodene, or drospirenone to those with levonorgestrel to prevent one event of VTE in one year, they said.

The U.S. Food & Drug Administration (FDA) is currently reviewing the safety of Yaz, Yasmin and other drospirenone birth control pills because of concerns about blood clots. In a Drug Safety Communication issued last month, the agency said the six epidemiologic studies it evaluated as part of that review presented conflicting information about the risk of blood clots. In addition, initial data from an FDA-funded epidemiologic study involving 800,000 women that is exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, found a 1.5-fold increase risk for blood clots among women taking contraceptives with drospirenone.

In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the names Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi, and Loryna. The FDA has yet to reach a conclusion on drospirenone birth control pills, but has scheduled an advisory panel meeting for Dec. 8 to discuss the matter.

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