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Yaz, Yasmin News from Europe

Mar 30, 2010 | Parker Waichman LLP

 

Yaz and Yasmin will be allowed to remain on the market in Switzerland, despite concerns about the drugs’ side effects. Meanwhile, Bayer Schering Pharma, a unit of Bayer AG, said Friday it will update its label for Yasmin in the European Union to include more information about blood clot risks.

Yaz and Yasmin are both made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Yasmin and Yaz side effects reported to the U.S. Food & Drug Administration (FDA) involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

In the U.S., these birth control pills have been named in hundreds of Yaz lawsuits filed by women around the country who claim the medications caused them to suffer blood clots, heart attacks, stroke, gallbladder disease and other health problems. On October 1, 2009, all lawsuits involving Yaz and Yasmin currently pending in federal courts were consolidated for centralized and coordinated pre-trial proceedings in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation in the United States District Court for the Southern District of Illinois before Judge David R. Herndon (MDL No. 2100). In December, Judge Herndon discussed scheduling a series of “bellwether” trials for the lawsuits, which will serve as a guideline for other cases.

In Switzerland, Swissmedic began reviewing Yaz and Yasmin last year, after two young women there each suffered a pulmonary embolism – a blood clot in the lung – while taking Yaz. One of the women, who had been taking Yaz for about 10 months, died. The other, a 16-year-old girl, was left disabled. Last week, the agency said that although the risk of thrombosis is higher with this generation of Yaz and Yasmin, the risk remains “within reasonable limits.”

Last Friday, Bayer announced that it would be updating the European label for Yasmin to include new information from four epidemiological studies, which provide conflicting information on the risk blood clots compared to other birth control pills containing a different form of progestin called levonorgestrel. Two of the studies found that the risk of blood clots from side effects of Yasmin was higher than with levonorgestrel. The two others – both paid for by Bayer – found that the risk of blood clots among users of Yasmin was comparable to the risk found in women who use levonorgestrel-containing combined oral contraceptives.


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