New safety information revealing the increased risk of blood clots in women has been added to the labels of Yaz and Yasmin. Bayer HealthCare Pharmaceuticals announced on March 26th that it will update the Yaz and Yasmin label in the European Union (EU) to include results of four epidemiological studies. Two of the studies, conducted in Denmark and the Netherlands, found that the birth control pills, which contain the hormone drospirenone, are associated with a notable increased risk to women. These risks include venous thromboembolism, more commonly known as a blood clot in a vein, which can lead to a pulmonary embolism or stroke. Bayer, the maker of Yaz and Yasmin, sponsored the other two observational studies. The Bayer-sponsored studies found that the risk of blood clots in Yaz and Yasmin users is comparable to the risk found for women who use birth control pills that contain the same hormone.
The FDA has been negotiating with Bayer to update the labels for Yaz and Yasmin in the United States. The updated label should clearly outline the dangerous association between the birth control pills and the increased risk of blood clots in women. At press time, the suggested change to the labeling information hadn’t been released. However, some researchers suggest that the updated label may not be intended as a warning to doctors and patients, but instead may be more of an attack on medical researchers who have insisted that Yaz and Yasmin may be unsafe.
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