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FDA: Stronger Labeling Needed for Newer Contraceptives

Dangerous Blood-Clot Risks Need to Be More Prominent on Future Labels
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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.

Obesity can also raise women’s risk of blood clots. David Grimes, MD, said obese women are 60% to 80% more likely to be prescribed an oral contraceptive containing drospirenone than non-obese women. Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina at Chapel Hill, was paid by Bayer to speak on behalf of its contraceptives at the advisory committee meeting.

Labeling Changes May Be Needed

Although the panel voted to keep the newer pills on the market, there was a strong divide among the experts.

Panelist Almut Winterstein, PhD, associate professor at the University of Florida College of Pharmacy, said the data also suggest Yasmin users are younger and healthier, so the increased risk of blood clots might actually be higher than the research has found. All birth control pills that contain estrogen and a progestin, including drospirenone, have a boxed warning on their labels about the risk of serious heart and blood-vessel problems such as blood clots in smokers over age 35.

The panel was nearly unanimous in saying the label on drospirenone contraceptives should explain even more clearly that some studies suggest they increase the risk of blood clots. But panelists questioned how to make that information comprehensible to doctors, let alone patients.

The FDA has not set a date to discuss the wording of the new labels.

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