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A Swiss health agency is investigating the death of a young woman in Switzerland who died while taking Bayer AG’s birth control pill Yaz. Bloomberg reported that Swissmedic (Switzerland’s drug therapy regulatory agency) and an investigative judge are probing the sudden death of the woman, whose autopsy revealed she died from the effects of a pulmonary embolism.
Bayer Healthcare’s blockbuster drug Yaz has come under fire in recent years for its potential to cause a spectrum of health problems. Bayer has downplayed these serious risks while drawing attention to some of the drug’s other uses as treatments for acne and the emotional and physical symptoms associated with premenstrual dysphoric disorder (PMDD). Adding to the confusion is a series of clinical tests designed to quantify the drug’s safety risks. Results of the studies have both supported cast doubt on the claims of women who say they have been harmed by Yaz. With your health and possibly your life at stake, who do you trust?
A new report in the New York Times about Bayer Healthcare’s bestselling oral contraceptive Yaz brings to light some serious ethical questions surrounding the company’s testing and marketing of what some studies suggest is a potentially dangerous drug for many women.
Yaz and Yasmin lawsuits filed against Bayer Healthcare in Pennsylvania state courts were consolidated into a mass tort last week by Philadelphia Court of Common Pleas judge Sandra Mazer Moss, who appointed 3 Pennsylvania attorneys to serve as liaison counsel for the plaintiffs.
The U.S. Food and Drug Administration has admonished German drug manufacturer Bayer for failing to test a vital ingredient used in Yaz and other birth control drugs according to American standards.
In October 2008, the U.S. Food & Drug Administration (FDA) sent a letter of warning to Bayer Healthcare, Inc., citing the drug manufacturer for misrepresentations in television commercials for Yaz, an oral contraceptive. The ads featured the usual women’s health metaphors showing happy ladies frolicking in a field releasing balloons and such. But according to the FDA, the real problem with the ads included overstating the drug’s effectiveness, overselling its benefits, and not adequately communicating its possible serious side effects, including cardiac arrest and gallbladder disease.
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