FDA Announces Yaz Study Regarding the Oral Contraceptive’s Link to Blood Clots
On May 31, 2011, the U.S. Food and Drug Administration (“FDA”) announced that it will undertake a review of the popular oral contraceptive Yaz to determine whether it puts patients at an increased risk for sustaining venous thromboembolism (“VTE”). Drospirenone is a type of progesterone used only in Yaz and Yasmin, and works by causing increased levels of potassium in the blood, which can, in some cases lead to a rare condition called hyperkalemia. Hyperkalemia can cause heart arrhythmias and blood clots, which can, in turn lead to heart attacks or pulmonary embolisms. Additionally, the blood clots can lead to blockages in the brain and cause a stroke, with severe and sometimes irreversible brain damage. The FDA is now informing the public about new information that is being evaluated as part of its continuous safety review of birth control pills, such as Yaz and Yasmin, which contain drospirenone. Additionally, the FDA’s Yaz study will evaluate the risk of blood clots in women who use drospirenone-containing oral contraceptives.
Yaz Study Seeks to Evaluate the Safety of Oral Contraceptives Containing Drospirenone
In the past few weeks, and as recent as June 1, 2011, there have been several reports linking oral contraceptive drugs that contain drospirenone to an increased risk of VTE. Specifically, “[t]wo recent reports in the British Medicial Journal found a twofold to threefold greater risk of blood clots in women taking pills like Bayer’s Yaz.”? In response to these reports, the FDA launched a Yaz study aimed at evaluating a possible link between Yaz and an increased risk of VTE. A recent FDA Yaz study observed clotting in 800,000 users; results from that Yaz study are expected to be released this summer. In addition to announcing the latest Yaz study, the FDA advised all prescribing healthcare professionals to continue “following the recommendations on drug labels when prescribing oral contraceptives that contain drospirenone.”? The FDA also advised clinicians to discuss the benefits and risks of drospirenone-containing products, such as Yaz and Yasmin, with patients and teach them about the signs and symptoms of VTE. In addition to the FDA Yaz study, on May 31, 2011 the European Medicines Agency concluded that birth control pills such as Yaz carry a an increased risk of VTE, and that the warning labels should be “updated accordingly.”? The FDA is expected to release any findings and new safety information from the Yaz study to the public as soon as they become available.
Dangerous Product Alert
If you or a loved one has experienced any medical issues as a result of taking Yaz or Yasmin, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact one of our Yaz/Yasmin lawyers today for a free and confidential lawsuit evaluation. The lawyers at Bernstein Liebhard LLP have extensive litigation experience and have recovered billions of dollars for their clients. In addition to being staunch advocates for your claim, our Yaz/Yasmin injury lawyers also provide personal attention to guide you through the complex litigation process.