FDA want more warning in Yaz label
Federal health experts said that drug labeling for Yaz and other widely-used birth control pills should be updated to emphasize recent data suggesting a higher risk of blood clots with the drugs than older contraceptive pills. The Food and Drug Administration’s panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and needs more information about the potential risk of blood clots in the legs and lungs.
Yaz, its predecessor Yasmin and related prescriptions use a manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone. Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. But prescriptions have fallen more than 80 percent in the last two years amid safety concerns. Panelists spent more than nine hours discussing often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be clearly stated in the label, including the potentially fatal nature of blood clots.
In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug’s overall benefit, citing numerous alternatives available. Two large studies conducted by German drugmaker Bayer have shown no difference in blood clots between patients taking the company’s drugs and patients taking older medications. But since 2009, five large studies have suggested drospirenone-containing pills carry a slightly higher risk of blood clots than older birth control pills, though events in both groups are very rare. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels. The most recent study by the FDA found women taking Yasmin had a 75 percent higher chance of suffering a blood clot than patients taking a combination of older drugs. The absolute risk of a blood clot is still far less than a fraction of a percent.
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