The US Food and Drug Administration (FDA) recently released the final report of an FDA-funded study regarding the risk of venous thromboembolism (VTE) in women taking hormonal contraceptives. VTEs include blood clots like deep vein thrombosis and pulmonary embolism.
The study of over 800,000 women found that women who take drospirenone-containing birth-control pills like Yaz, Yasmin and Ocella, are significantly more likely to develop a VTE than women using standard low-estrogen birth control pills. In women age 35 to 55 taking these drugs, the study found a higher risk of arterial thrombotic events in users overall.
The study also found NuvaRing users are at an increased risk for VTE when compared to women taking low-estrogen birth control pills.
FDA has recommended that birth control pills like Yaz, Yasmin, and Ocella be studied more for their cardiovascular side effects. It issued the following statement after it released the study:
FDA has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
These findings were presented and discussed at the joint meeting of the Reproductive Health Drugs and Drug Safety and Risk Management FDA Advisory Committee on December 8, 2011. The FDA voted and approved a change in the labels for Yaz and Yasmin to include the information about the higher risk of blood clots.
Read more about the FDA's decision on Medpage Today and the Boston Globe.
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