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Possible Yaz-Related Death Sparks Swiss Investigation

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Bayer is facing more trouble over Yaz lawsuits, this time a Swiss probe following the “sudden” death of a young woman who had been taking the oral contraceptive.

According to a report on Bloomberg.com, Swissmedic and an investigative judge are looking into the death. The victim had been taking  Yaz for 10 months and died from the affects of a pulmonary embolism she suffered in mid-September.  According to a Reuters report, Swissmedic began investigating all birth control pills after a 16-year-old girl was disabled by a lung embolism in May after taking Yaz.

Yaz was approved in the U.S. in 2006.  It is a low-estrogen pill, and is made with a type of progestin called drospirenone.  As we’ve reported previously, drospirenone is known to carry some health risks not seen with other forms of the hormone. Most notably, it can increase the levels of potassium in the blood, which can lead to a disorder called hyperkalemia in high risk patients. This condition may result in potentially serious heart and health problems, including fatal cardiac arrhythmias and other Yaz side effects. High potassium levels are especially dangerous for people who are obese, or who have diabetes or high blood pressure.

Since early 2004, the U.S. Food & Drug Administration (FDA) has received over 50 reports of deaths in women who were taking Yaz and other drospirenone-containing contraceptives. Many of the reported deaths involved elevated potassium levels. The deaths were caused by a variety of ailments, including cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs) and stroke in women in their child bearing years.

Recently, The New York Times reported on the increasing concerns over the safety of Yaz and Yasmin.  The article pointed out that two separate Dutch and Danish studies published last month in The British Medical Journal found a higher risk of venous blood clots for women taking newer progestins, including drospirenone. The FDA is  also reviewing the safety of birth control pills with a study designed to identify the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives.   The Times also reported that Bayer is conducting a postmarketing study comparing the safety of Yaz with other birth control pills.

At least 74 lawsuits have been filed across the country on behalf of plaintiffs who claim they suffered serious injuries because of their use of Yaz and its sister drug, Yasmin.   Plaintiffs in these lawsuits claim Bayer overstated the benefits of these drugs and failed to adequately warn of their risks. On September 24, 2009, a hearing was held before the Judicial Panel on Multi-District Litigation on a petition to consolidate all Yaz and Yasmin litigation in one federal court as a Multi-District Litigation.  A decision on the petition is expected in a few weeks.

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