FDA decides to strengthen warning labels on oral contraceptive YAZ, Yasmin

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The Federal Drug Administration (FDA) has recently decided to strengthen warning labels on the oral contraceptive YAZ and its sister drug Yasmin regarding increased risks of blood clots from using the medications. Baron and Budd, a national law firm dedicated to protecting the rights of consumers, is warning women about the new labels and the adverse health effects of YAZ, Yasmin, Beyaz and Ocella.    

YAZ, Yasmin, Beyaz and Ocella belong to a newer family of birth control pills that contain drospirenone (DRSP). Studies have found that women who use birth control pills that contain DRSP are at an increased risk of developing blood clots when compared to traditional birth control pills.

The new FDA warnings follow the recommendations of an FDA advisory committee that evaluated the potential health risks of YAZ and other DRSP-containing birth control pills. After reviewing studies of the health risks, the committee recommended stronger warning labels for the DRSP family of drugs.

"Women need to be aware of things that could threaten their health," said Laura Baughman, attorney at Baron and Budd. "Even though YAZ has been aggressively marketed to treat a variety of issues, that does not mean that it can deliver on all of those promises. In fact, in 2008 Bayer was forced to run a $20 million ad campaign to clarify the company's previous commercials about YAZ, which, according to the FDA, were misleading because the ads promoted YAZ for conditions that it was not approved for and downplayed potential risks of the drugs - like blood clots."

The most common health issues associated with YAZ are blood clots and other problems associated with blood clots such as heart attack, stroke and pulmonary embolism.

More than 10,000 lawsuits have been filed by women who have suffered blood clots and other adverse side effects from taking YAZ or Yasmin, including at least four class action lawsuits. Bayer recently agreed to settle the first group of lawsuits regarding blood clots for approximately $110 million. Other lawsuits are still in process. Regardless, it is not too late to file a lawsuit for serious health effects from YAZ, Yasmin, Beyaz or Ocella.    

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