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FDA adviser: revise popular birth control labels
ADELPHI, Maryland |
ADELPHI, Maryland (Reuters) - Health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.
Outside experts advising the Food and Drug Administration on Thursday voted 21-5 that current labels inadequate reflected the risks and benefits of a newer generation of pills that contain the compound drospirenone, including Bayer AG's popular Yaz and Yasmin.
In a very close vote of 15 to 11, the panel nonetheless concluded that benefits of preventing unwanted pregnancies outweighed risks.
Evidence from all studies since the Yasmin was first approved in 2001 presents conflicting data about the riskiness of drospirenone but concerns have been mounting in recent years that Bayer's pills could lead to possibly fatal blood clots.
(Reporting by Alina Selyukh; Editing by Gary Hill)
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