Preliminary results of a U.S. Food and Drug Administration (FDA) funded study have added significant weight to the long-suspected link between fourth generation oral contraceptives and severe, life-threatening cardiovascular complications. More specifically, birth control pills containing drospirenone may significantly increase a woman’s risk of developing deep veinous thrombosis (DVT) and pulmonary embolism (PE). Recent studies suggest that increased potassium levels in the blood are directly correlated to the pro-thrombotic effects of drospirenone. Subsequently, severe blood clot risks have been imparted by the use of drospirenone-containing contraceptives.
Fourth generation contraceptives, those containing drospirenone, consist of Yaz,Yasmin, Beyaz and Ocella. According to a recent study funded by the FDA, these birth control pills may demonstrate a propensity for the development of adverse cardiac events. Subsequently, complaints have been filed on behalf of women who have suffered heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other serious blood clot-related injuries.
The new study released by the FDA looked at the medical history of more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, woman taking Yaz had a 75 percent greater chance of developing a blood clot than women who took older birth control drugs without drospirenone. The study also included detailed accounts of many other top selling oral contraceptives that coincide with severe blood clots.
According to a study recently published in the British Medical Journal, users of oral contraceptives that contain drospirenone were at twice the risk of venous thromboembolism compared with users of older oral contraceptives that contain levonorgestrel. Officials reviewed data obtained from four registries in Denmark. Researchers looked at data on all Danish women between the ages of 15 and 49 who were not pregnant between January 2001 and December 2009. Their findings acknowledged 4,246 cases of adverse venous thromboembolic events. Most of those events were DVT, a blood clot that cuts off circulation in a limb. Subsequently, 25% of the women suffered from a PE, a significant blood clot that travels to the lungs. A small percentage of women experienced a stroke because of the severity of their blood clot.
Despite the correlations between fourth generation contraceptives and adverse cardiac events, recent studies have reached differing conclusions on the risks of newer birth control pills. According to two post-marketing studies published in 2007, European regulators were unable to find substantial differences in blood clotting between fourth generation contraceptives and older ones containing levonorgestrel.
Due to the severity and frequency of the reports associated with fourth generation contraceptives, the FDA has scheduled an advisory board meeting for December 8 to discuss the safety and effectiveness of such products. The FDA hopes to differentiate between contradicting reports and find a solution to the current problem. In doing so, the FDA is attempting to prevent an influx of adverse cardiac events in the future.
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