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Yaz Side Effects Lead to Additional Warning From FDA

April 20, 2010

Yaz Side Effects Lead to Additional Warning From FDA

Bayer Healthcare is once again being required by the U.S. Food and Drug Administration to update the marketing material for its popular prescription birth control medication Yaz and Yasmin. The latest update in the company’s marketing and advertising comes with new information about the drospirenone-based contraceptives and reports and accusations that Yaz and Yasmin may cause blood clots.

The latest U.S. market announcement mirrors a recent similar announcement in Europe, in which Bayer was forced to add warnings about the higher risk of blood clots to the packaging of Yaz and Yasmin. The FDA informed Bayer in a letter last week that the pharmaceutical manufacturer was responsible for updating current information quickly and completely.

More than 1,100 lawsuits have already been filed against Bayer because of accusations that Yaz and Yasmin have allegedly been responsible for a variety of serious side effects, including blood clots, deep vein thrombosis, pulmonary embolisms, gallbladder disease, strokes, and heart attacks.

Previously, the U.S. Food and Drug Administration warned Bayer about misleading information in the company’s marketing campaigns. This resulted in a corrective advertising campaign that cost Bayer more than $20 million. Bayer’s corrective campaign included a series of new commercials aimed at delivering more concise information to the millions of female consumers still using the best-selling contraceptive medication.

Drospirenone, the key ingredient in Yaz and Yasmin, raises the potassium level in the body, which can lead to serious complications with blood clots and gallstones, thus in turn leading to gallbladder disease. Yaz and related contraceptive medications have been blamed in lawsuits for at least 50 deaths.

In 2009, Yaz accounted for more than $1.7 billion in profit for Bayer, as Yaz was and still is the leading brand of female birth control in North America.

If you or a loved one has experienced a serious side effect or symptoms of side effects related to Yaz, Yasmin, or the generic Ocella, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication recalls. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.
 

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