FDA panel wants label change for Yaz, Yasmin

An FDA advisory committee backed Bayer's ($BAY) birth control pills Yaz and Yasmin in a 15-11 vote yesterday, saying their benefits outweigh their risks. But the panel also recommended changes to the contraceptives' labels to reflect the possibility the pills could lead to a higher risk for blood clots.

As The New York Times reports, the committee voted 21-5 for changing the drugs' labels, but didn't approve of a warning that Yaz and Yasmin users were more likely to develop blood clots than women taking other birth-control pills. Rather, the panelists recommended new labels noting that current evidence of clotting risk is conflicting.

FDA's own study found a 74% increase in the risk of blood clots in women using Bayer's line of drospirenone contraceptives, but the data was drawn from billing databases, so it couldn't account for risk factors such as smoking and obesity, The Wall Street Journal notes. Bayer-funded studies haven't come up with any increase in clotting risk, and some privately financed trials haven't either. But other independent trials have.

Many physicians see the absolute increase in risk isn't enough to change their prescribing habits, Bloomberg reports. One Harvard professor told the news service the clotting danger "is so rare it's clinically not that important."

Still, some advisory committee members believed doctors should be cautious with these pills. "I think these drugs ought to be rarely used," said panel member Sean Hennessy of the University of Pennsylvania (as quoted by the WSJ). Meanwhile, Bayer is fighting thousands of lawsuits alleging its line of drospirenone contraceptives caused blood clots and deaths.

- see the NYT coverage
- read the WSJ piece
- check out the Bloomberg story
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