FDA advisers suggest revising popular birth control labels

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U.S. health advisers recommended a revision of labels for the new generation of widely used birth control pills that contain the compound drospirenone (i.e., Yaz, Yasmin). Although all common birth control pills increase women’s chances of getting blood clots, data has been mounting that reveals a higher risk linked with these newer pills. Outside experts advising the Food and Drug Administration agreed that the current, rather complex label does not adequately help women and doctors understand the risks and benefits of such pills. “[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,” said panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa Caver College of Medicine. An FDA study conducted in 2011 found that women taking Yasmin were about twice as likely to develop venous or arterial thrombotic events (VTEs and ATEs) than women on older birth control. This study also estimated that 10 in 10,000 women taking the newer drug would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

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