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Yaz Blood Clots: FDA Updates Yaz Label for Increased Risk

Texas women who take the birth control pills Yaz and Yasmin will notice a new label on the pills, warning them of the dangers of Yaz blood clots.

FDA Yaz Panel Finds High Yaz Blood Clots Risk
In December 2011, the U.S. Food & Drug Administration convened a panel of experts to determine whether new generation birth control pills like Yaz and Yasmin should be taken off the market because of the increased risk of blood clots. The panel decided that Yaz’s benefits outweigh its risks, despite evidence from an FDA study that revealed the risk of blood clots in women taking Yaz was as high as 75 percent more than with other hormonal contraceptives.

Experts believe that Yaz, Yasmin, and their generics have an increased risk of blood clots because of the synthetic hormone they contain, drospirenone. The Yaz panel evaluated the FDA's study and voted 15 to 11 to keep Yaz on the market. Those experts who voted to keep Yaz on the market argued that the pills are beneficial to women, while those who voted to take Yaz off the market argued that Yaz has no clear benefit and that safer, alternative birth control pills are available.

FDA Yaz Panel & Conflicts of Interest
After the panel convened, news leaked that four of the experts on the Yaz panel had ties with Bayer, the maker of Yaz. At least one of the experts was paid by Bayer for a clinical trial she had conducted on the use of drospirenone in hormone replacement therapy. She has denied having any bias for Bayer.

A second expert was paid as much as $10,000 by Bayer in 2010 for consulting work, and two other experts had conducted studies that had been funded by Bayer. All of the experts on the panel were required to disclose their ties to Bayer and potential conflicts of interest, but the FDA found these acceptable and allowed all four experts to vote on the panel.

One expert who was not allowed on the panel is Dr. Sidney Wolfe of consumer advocacy group Public Citizen. The FDA cited his consumer guide “Worst Pills/Best Pills” in which he warns women not to take birth control pills that contain drospirenone because they pose a substantially increased risk of blood clots. While Dr. Wolfe was allowed to take part in the panel, he was not allowed to vote. The FDA cited an “intellectual conflict of interest” as the reason why it did not let Dr. Sidney have a vote.

Symptoms of Yaz Blood Clots
Yaz and its generics were originally marketed as lifestyle drugs, promising to lessen the effects of premenstrual syndrome (PMS) in women. In 2009, the FDA required Bayer to issue corrections in its advertisements of the drug, but arguably the damage has already been done. Women still take Yaz and Yasmin in the hopes that their skin will be clearer and their PMS symptoms will be gone. In fact, birth control pills that contain drospirenone are still the best-selling contraceptives in the United States because of the ways in which they have been marketed.

If you are taking Yaz, Yasmin, or any of its generics, you may want to talk to your doctor about switching to a birth control pill that does not contain drospirenone. Otherwise, if you continue to take Yaz, be sure you know the symptoms of a Yaz blood clot, which include:
  • Pain in the leg
  • Swelling in the leg
  • Red, bluish or white skin
  • Skin that’s warm to the touch
  • Leg cramps
  • Chest pain
  • Shortness of breath
  • Difficulty breathing
  • Loss of consciousness 

Yaz Blood Clot Litigation
An estimated 6,000 lawsuits have been filed against Bayer for injuries sustained by women while taking Yaz or Yasmin. If you or a loved one suffered Yaz blood clots, you may be entitled to compensation for your injuries. Call Dallas Yaz injury attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082 to learn more about how to protect your legal rights.
Kay Van Wey
Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization

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