FDA wants more prominent label warning in Yasmin
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. There is no research to suggest that pills containing drospirenone are more effective at preventing pregnancy than other birth control pills . And most of the older oral contraceptives treat acne just as well, Adriane Fugh-Berman, MD, an associate professor in family medicine at Georgetown University, told the advisory panel.

Much of the discussion at the day-long advisory committee meeting focused on whether Yasmin might have a higher or lower risk of blood clots compared to the older birth control pills. In the FDA study, women on Yasmin were twice as likely to have acne, which can be a characteristic of PCOS, than those on older birth control pills, Ouellett-Hellstrom said. PCOS alone puts women at a higher risk of blood clots.

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