Yaz Birth Control Lawsuit - Consumer Drug Report
FDA mandates stronger warning label for YAZ

Federal advisers recommended this past Thursday that new generation birth control pills such as Yaz should have stronger FDA warning labels regarding the risks of blood clots associated with use.

In a meeting scheduled by two advisory committees for the Food and Drug Administration, it was determined based on voting results that the benefits of Yaz preventing unwanted pregnancies outweighed the health risks associated with it. However, in a second round of voting, the committee determined that the popular birth control pills should be labeled with stronger warning labels.

Rising concerns about the safety of Yaz, which is widely prescribed, is the cause for the hearing between the two committees. Results from a study conducted on women who take new generation birth control pills and women taking older oral contraceptives show that the women taking the newer birth controls face a higher risk for life threatening blood clots than women taking older oral contraceptives.

“The newly mandated FDA warnings proves that this drug was only about profit for Bayer and had very little to do with women’s health. The older oral contraceptives are not only safer and just as effective, but far less expensive too,” states Stuart Scott, Yaz attorney at Spangenberg, Shibley & Liber, a Cleveland based law firm.

Newer birth control pills, including Yaz, Yasmin, Beyaz, and Safyral, all contain a synthetic hormone progestin known as drospirenone which was believed to have fewer side effects. Bayer, the maker of Yaz and Yasmin, was found by the FDA to make exaggerated claims regarding the benefits of taking Yaz and Yasmin. The drug maker ran heavy promotions claiming that the pills offered greater benefits over standard birth control pills, such as alleviating acne and preventing moodiness. In 2009, the FDA asked Bayer to run corrective advertising.

Yaz was introduced in 2006 and quickly became the fastest growing birth control pill in the U.S. According to IMS Health, a company which tracks pharmaceutical sales, Yaz brought in revenues in 2009 of $781 million. However, due to emerging safety concerns, sales have dropped to $374 million making it the fourth most popular birth control pill.

Some studies suggest that the birth control pills pose greater health risks than blood clots including heart attacks, strokes, and fatal blockage of lung arteries. In a study of over 800,000 women, conducted by the FDA, results show that women taking newer generation birth control pills face a 74% higher risk of developing blood clots than women not taking oral contraceptives.

Currently Bayer faces thousands of Yaz lawsuits, all making similar allegations that the birth control pills cause blood clots. Bayer counters these allegations by claiming the pills are safe and that no increase in blood clots were shown in their own studies of the drug.

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