En Español [BEYAZ]
On September 26, 2011, the FDA issued a warning that the use of birth control medications that contain drospirenone could potentially be linked to an increased risk of blood clots. The announcement came after the FDA completed a review of two studies from 2011 that evaluated the risk of blood clots in women who use medications that contain drospirenone. Furthermore, the FDA has funded a study that evaluates the risk of blood clots in women who use hormonal birth control products. Preliminary results of that study suggest that women who take a birth control pill containing drospirenone has approximately 1.5 times the risk of blood clots of women who use other hormonal contraceptives.
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On May 31, 2011, the FDA issued an alert that the agency was assessing information about the risks associated with the use of drospirenone in birth control pills. According to the announcement, drospirenone is a type of female hormone called progestin.
"All birth control pills pose a risk of blood clots," the FDA announcement stated. "Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported an increase in risk."
On December 8, 2011, an FDA advisory panel ruled that birth control drugs containing drosperinone should include a warning about the risk of blood clots. The panel voted 21 to 5 that current warnings concerning the risk of blood clots were not strong enough and recommended that the FDA should strengthen those warnings. The panel voted 15 to 11 to keep drospirenone birth control medications on the market.
Blood clots can be serious, especially if they form in a deep vein (a condition called deep vein thrombosis, or DVT). If blood clots break loose from the vein and move to the lung, they can cause a pulmonary embolism, which can be fatal. According to the FDA, two recently published studies found an increased risk for blood clots in women taking drospirenone-containing pills compared with women taking levonorgestrel-containing pills.
A study published in the British Medical Journal (04/21/11) found that women who are currently using contraceptives that contain drospirenone had approximately three times the risk of developing a non-fatal idiopathic venous thromboembolism as women who used contraceptives that contain levonorgestrel.
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"This study adds to the emerging evidence that use of the oral contraceptive containing drospirenone is associated with a higher risk of venous thromboemolism than are preparations containing levonorgestrel," researchers wrote. "Perhaps now is the time for a systematic review on this topic." They went on to note that there is no clear evidence that drospirenone pills have greater benefits than contraceptives that contain levonorgestrel, making drospirenone a less than ideal first line contraceptive.
Meanwhile, a second study also published in the British Medical Journal (04/21/11) found that woman who used birth control that contained drospirenone had approximately double the risk of non-fatal venous thromboembolism as women who used a birth control that contained levonorgestrel.
According to the website, Beyaz is a birth control pill that also provides a daily dose of folate, which is a B vitamin. Beyaz is approved to prevent pregnancy, provide daily folate supplementation and treat premenstrual dysphoric disorder. Beyaz is manufactured by Bayer HealthCare Pharmaceuticals.
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