Friday, December 9, 2011

FDA Says Yaz Label Should Be Rewritten,

In a 21 to 5 vote yesterday, FDA advisers said that the labels on certain oral contraceptives do not adequately reflect the risk-benefit profile of these drugs. The pills in question contain the hormone drospirenone. The brand names for these products include Yaz, Yasmin, Beyaz and Sayfral. Over the last two years, several large, independent studies have suggested the rate of blood clots with drospirenone-containing drugs is slightly higher than with other hormone-based contraceptives. The most recent analysis by FDA estimates that 10 in 10,000 women on the newer drugs will experience a blood clot, compared with 6 in 10,000 women on older contraceptives, which contained another hormone called levonorgestrel, a progestin.