As previously reported, in December 2011, the Federal Drug and Administration (FDA) ruled that the label warning on Bayer Yaz and Yasmin regarding the increased risk of blood clots was inadequate. The decision followed a nine-hour hearing during which the FDA’s Advisory Committee listened to testimony and, according to the FDA website, “discuss[ed] the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel.”
As part of its December 2011 ruling, the FDA ordered that Bayer revise its label to warn of the higher risk of blood clots, although no timetable for the changes was set. In April 2012, Bayer announced that it was changing its label to report that some studies show that the risk of blood clots for women taking Bayer Yaz or Yasmin may be three times higher than women who were taking pills containing levonorgestrel or some other progestins. However, the label will also note that other studies have shown there to be no greater risk for blood clots. A summary of the results of the FDA-funded study will also be included.
If you have suffered a heart attack, Yaz stroke, deep vein thrombosis or pulmonary embolism while taking YAZ® or Yasmin®, contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, to help you assess any claims that you might have against the YAZ® or Yasmin® manufacturers.