New York, NYYasmin lawsuits, alleging women suffered Yasmin side effects after using the birth control, have reportedly cost Bayer AG more than $400 million in settlements. The lawsuits allege women suffered Yasmin birth control side effects, including blood clots that can lead to heart attacks and strokes.
According to Bloomberg Businessweek (7/31/12), Bayer has said it paid approximately $400 million to settle approximately 1,900 lawsuits. That works out to an average of around $212,000 a lawsuit. This does not resolve all the Yasmin lawsuits, as Bayer reportedly faced more than 12,000 lawsuits concerning Yasmin. In addition to allegations about blood clots, Bayer faces allegations that Yasmin is linked to gall bladder problems. Furthermore, lawsuits claim Bayer misled women about the risks associated with the birth control.
The Yasmin and Yaz lawsuits are filed under case number 09-md-02100, US District Court, Southern District of Illinois.
On April 10, 2012, the US Food and Drug Administration (FDA) requested Bayer strengthen the warning labels on certain birth control products, to reflect data indicating that drosperinone—a synthetic hormone—could triple the risk of blood clots.
"The revised drug labels [ordered for Yasmin, Yaz, Safyral and Beyaz] will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products, compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products," the FDA wrote. The agency noted, however, that the risk of developing a blood clot from birth control is still lower than the risk of developing blood clots during pregnancy or postpartum.
Studies reviewed by the FDA did not account for patient characteristics that could influence prescribing of the birth control. Those characteristics could increase the risk of blood clots, rather than the increase being due solely to the birth control itself.
Although two recent studies suggest an increased risk of blood clots and venous thrombolic events in women using certain birth control, other studies have found no such risk.
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