The Food and Drug Administration released a safety alert regarding a higher risk for blood clots in women taking birth control pills containing Drospirenone, such as Yaz and Yazmin.
As a result of the alert, Bayer must revise Yaz and Yasmin labels to include the new FDA warning. The new labels must report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products, according to the FDA. The labels will also include a summary of the previously released results of an FDA-funded study of the blood clot risk.