The FDA is taking a look at new data suggesting higher risks for certain birth control pills. In the wake of two new studies, the agency said it would review the evidence on contraceptives containing the hormone drospirenone, including Bayer's popular Yaz and Yasmin pills.
Released last month, the new studies found that women taking drospirenone contraceptives were more likely to develop blood clots than those using an older form of birth control pill. Insurance data from one study showed that women taking the newer pill had clotting risks 2.3 times greater than those using the older form. In the other study, women using the drospirenone pills were three times more likely to develop a blood clot. But, as Pharmalot points out, the absolute risk in both studies remained small.
As the FDA notes, other studies have produced conflicting results--some identified increased risk of blood clots, while others did not. The agency therefore will have to sift through the data. Meanwhile, the FDA is awaiting the final results of a large study examining the link between blood clots and hormonal contraceptives.
Bayer's Yaz franchise brought in $1.47 billion in sales last year, Bloomberg notes. The company is facing more than 6,000 liability lawsuits over the drugs. Meanwhile, Bayer says it stands by its contraceptives' safety profile. "Patient safety is Bayer's top priority," the company told the news service. "Bayer's analysis of the overall body of available scientific evidence continues to support its current assessment about the safety of its oral contraceptives."