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FDA Advisory Panel Wants Birth Control Labels Revised

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As concerns grow over data that a newer generation of birth control medications such as Bayer’s Yaz and Yasmin, increase the risk of dangerous blood clots, an expert advisory panel has agreed that current labels do not adequately help physicians and women understand the risks and benefits of the oral contraceptives.

Reuters reported that panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa, Caver College of Medicine said, “(The label) is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we’re delusional.” 

A number of studies have been performed on Yasmin, the first birth control pill containing the hormone drospirenone approved for sale in the United States, and gave conflicting evidence regarding whether the drug increases the risk of developing blood clots. However, some panel members took issue with the fact that only Bayer sponsored studies found Yasmin to be equally safe to older generation birth control pills.

In a study performed by the FDA, results showed that women who used Yasmin where nearly twice as likely to develop venous or arterial thrombotic events, than women who used older low dose birth control pills. The study estimated that 10 in 10,000 women who take drospirenone-control birth control get a blood clot. However, other factors influence the risk of blood clots, including if a woman smokes, is overweight, has a history of blood clots, or has clogged arteries.

 

breakinglawsuitnews.com disclaimer: This article: FDA Advisory Panel Wants Birth Control Labels Revised was posted on Friday, December 9th, 2011 at 7:14 pm at breakinglawsuitnews.com and is filed under Defective Drug Lawsuits.

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