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FDA: Stronger Labeling Needed for Newer Contraceptives Sat Dec 10, 2011 1:59 am
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FDA: Stronger Labeling Needed for Newer Contraceptives


Dec. 9, 2011 -- An FDA panel has voted 15-11 that the benefits of newer oral contraceptives outweigh their risks of dangerous blood clots.

But the panel voted 21-5 that the contraceptives’ labels don’t adequately reflect that risk/benefit profile.

The newer oral contraceptives, which contain the man-made hormone drospirenone, include Bayer Healthcare Pharmaceutical's Beyaz, Safyral, Yasmin, and Yaz brands, as well as several other brands (Gianvi, Loryna, Ocella, Syeda, and Zarah).

They’ve been marketed as having extra benefits such as treating acne and severe premenstrual symptoms.

All oral contraceptives carry a potential risk of blood clots, but publicly funded studies, including one of 800,000 women by the FDA, have linked the drospirenone-containing oral contraceptives to a higher risk of clots compared to the older contraceptives, which contain the hormone levonorgestrel.

The research shows that about 10 in 10,000 women taking the newer pills would get a blood clot per year, compared to 6 in 10,000 women taking the older pills.

However, research funded by Bayer has not shown an increased risk of clots in women who took Yasmin, an earlier version of Yaz.

Almost all of the studies have focused on Yasmin, which in 2001 was the first pill containing drospirenone to earn FDA approval.

http://www.webmd.com/sex/birth-control/news/20111209/fda-stronger-labeling-needed-newer-contraceptives?src=RSS_PUBLIC
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FDA: Stronger Labeling Needed for Newer Contraceptives Sat Dec 10, 2011 1:59 am
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