Labels For Some Birth Control May Require Stronger Wording

BALTIMORE A panel of experts commissioned by the U.S. Food and Drug Administration met in Maryland on Thursday and recommended that some birth control pills may need stronger warning labels.

Experts said the new generation of birth control pills, like Yaz and Yasmine, contain a new type of hormone called drospirenone, and several studies have suggested that women who take these types of birth control pills have twice the risk for developing blood clots compared to those taking older forms of pills.

Resident Joan Cummins said her daughter, 18-year-old Michelle, was taking Yaz when she died from a blood clot in her lungs last year.

“I need my daughter back, and you can’t give her back. But you can, you absolutely can prevent other mothers from coming here with broken hearts,” Cummins told the panel during the FDA hearings in Prince George’s County.

Medical experts said the overall risk for blood clot is low — about 10 out of every 10,000 women will experience the complication, and it’s estimated that more than 12 million women in the U.S. and more than 100 million worldwide have taken Yaz or Yasmine.

“If you think of the millions of women using oral contraceptives, the benefits of Yaz translate to a considerable number of women,” said Dr. Andrea Lukes, of the Carolina Women’s Wellness Center.

The majority of experts on the panel voted that the warning label* included with both Yaz and Yasmine should be revised, but no decision was made as to what those revisions should be. Some critics, however, said that a change in labeling is not enough.

“I’m very concerned that if they don’t take this drug off the market, there are going to be even more girls and young women harmed in the future,” said Diana Zuckerman, of the National Research Center for Women and Families.

Bayer Pharmaceuticals, the maker of Yaz and Yasmine, said experts found no increased risk of clots during pre-market testing. The pills generate $1.5 billion in sales for the company.