FDA: Stronger Labeling Needed for Newer Contraceptives
Dangerous Blood-Clot Risks Need to Be More Prominent on Future Labels
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.