FDA advisers: revise popular birth control labels

U.S. health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.

Although all common birth control pills increase women's chances of getting blood clots, concerns have recently been mounting about an even higher risk linked to a newer generation of pills that contain the compound drospirenone, such as Bayer AG's popular Yaz and Yasmin.

Outside experts advising the Food and Drug Administration on Thursday, in a 21-5 vote, agreed that the current, rather complex label does not adequately help women and doctors understand the risks and benefits of such pills.

"(The label) is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we're delusional," said panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa Caver College of Medicine.

Nonetheless, in a very close vote of 15 to 11, the panel concluded that benefits of preventing unwanted pregnancies did outweigh the risks.

A number of studies have been conducted on Bayer's Yasmin, the first drospirenone-containing contraceptive to be approved in the United States in 2001. And overall, the evidence is conflicting whether the compound indeed raises the chances of developing potentially fatal blood clots - something that made some panelists reluctant to seek drastic changes to the label.

However, several panel members pointed out that only Bayer-sponsored studies seemed to find Yasmin equally safe as other birth control pills.

"I found that disturbing," said Dr. Maria Suarez-Almazor, a professor at the University of Texas MD Anderson Cancer Center, to applause from numerous women's advocates and patients.

Many of them earlier tearfully recounted sudden deaths and life-changing disabilities they or their loved ones suffered from blood clots they believe were caused by Yaz or Yasmin.

"Most people only see the watered-down label ... We know that labels just don't change behavior," said Cynthia Pearson, executive director of the National Women's Health Network, one of several consumer advocacy groups that argue the drugs should be taken off the market entirely.

FDA REVIEW

FDA's own study earlier this year found that women taking Yasmin were about twice as likely to develop venous or arterial thrombotic events (VTEs and ATEs) than women on older birth control. The risk of VTEs was especially higher in women under 35 while risk of ATEs was higher in women older than 35.