FDA Debates Pulling Yaz From the Market

Yaz and Yasmin (generic: drospirenone) are two of the most widely used oral contraceptives in the United States. Women taking these dangerous drugs containing the progestin drospirenone may have an increased risk of blood clots and other injuries.

Most Common Drospirenone Adverse Effects:

• Pulmonary Embolism
• Deep Vein Thrombosis (blood clots)
• Gallbladder Injury
• Thrombosis

FDA Warning

On September 26, 2011, the U.S. Food and Drug Administration (FDA) released a Safety Communication reporting that it “remained concerned” about the potential increased risk of blood clots associated with the use of drospirenone-containing birth control pills.

Recent Study Confirms Risks
This warning followed a review of the preliminary results of an FDA-funded study involving 800,000 women, which uncovered a 1.5-fold increase in the risk of blood clots, also known as venous thromboembolism (VTE), for women who use drospirenone-containing birth-control pill, as compared to users of other hormonal contraceptives. These blood clots have the potential to be fatal.

Will Yaz Be Banned?

The FDA has scheduled a joint meeting of the Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits, specifically the risk of blood clots, of drospirenone-containing birth control pills. During this meeting, the FDA will hear testimony concerning these studies. The safety of these medications will likely decide whether Bayer will be required to remove Yaz from the market for good.

Contact Us

If you or a loved one has experienced problems related to your health from Yaz or Yasmin, contact the attorneys at Childers, Schlueter & Smith, LLC today. We are experienced pharmaceutical lawyers who have extensive knowledge of drospirenon-containing drugs, and we are determined to protect the rights of patients. We will listen to your story and help you determine the best course of action for your case.