British and US Reports Show Increased Fatal Risks With Yaz

U.S. health regulators are still worried about the potential for Yasmin and Yaz blood clots posed by the drospirenone-containing birth control pills. In a Drug Safety Communication posted on its website yesterday, the U.S. Food & Drug Administration (FDA) said preliminary results of an agency-funded study suggest women who use Yaz, Yasmin and other oral contraceptives made with drospirenone could face a 1.5-fold increase in the risk of blood clots compared to those who take other pills. More recently, two articles published in 2011 in the British Medical Journal reported a 2- to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone rather than levonorgestrel.

Complaints have been filed on behalf of women who have suffered heart attacks, strokes, Yaz pulmonary embolism, deep vein thrombosis and other

serious blood clot-related injuries, which they allege may have been prevented if more adequate information about the Yasmin and Yaz blood clot risk had been provided. Initial data from the FDA-funded epidemiologic study involving 800,000 women that is exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with conclusions from the 2009 and 2011 published studies, finding a 1.5-fold increase risk for blood clots among women taking contraceptives with drospirenone.

Yaz (droperinone & ethinyl estradiol) is a once-a-day birth control pill that was first approved by the FDA in March 2006 to prevent unwanted pregnancy.  In October 2006, approval was expanded to include treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD), which is a more severe version of PMS that interferes with daily activities.  In January 2007, it was also approved to treat moderate acne in women who already desire birth control. About 6,350 cases of Yasmin and Yaz lawsuits are now consolidated as part of the litigation before Judge Herndon in the U.S. District Court for the Southern District of Illinois. When Judge Herndon implemented the original bellwether program in October 2010, there were about 3,700 filed cases and the number of cases is expected to continue to grow as Yaz and Yasmin lawyers review and file additional cases.