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FDA meets over birth-control warning labels

December 8, 2011 12:00:00 AM PST
Do the benefits of certain types of birth control outweigh the risks? That's the question that was debated Thursday before a Food and Drug Administration (FDA) expert panel.

New studies have suggested the popular drug Yaz raises an extreme risk of blood clots. Should women be concerned?

Millions of American women take birth-control pills. But the risk for blood clots isn't something most doctors talk about when they prescribe birth control.

Stephanie Fischer, a young woman from Valencia, feels strongly about the government making the warning labels more prominent.

"The doctor picked up the phone, he passed it to me and he said, 'Stephanie, this is really serious," said Fischer, 25.

So serious, Fischer ended up in a wheelchair for four months. A blood clot inflamed her left leg, but the worst part was knowing that at any moment the clot could break off and choke off her heart or lungs.

"When he told me that, I was like, 'Oh my God, tomorrow, today, in an hour -- it could be my last day,'" said Fischer.

Doctors told her it was probably caused by her birth-control pills.

"Afterwards they did confirm it was the birth control, and they made me get off of it immediately," said Fischer.

About five in 10,000 women may get a blood clot from taking oral contraceptives, but the popular drug Yaz came under fire because of reports the risk is twice as high when taking it.

New evidence presented to the FDA suggests the top-selling drug, Yaz, made by Bayer, possibly doubled the risk of blood clots.

Dr. Rudy Quintero, with Glendale Adventist Medical Center, disputes the quality of the evidence. Quintero is not Fischer's doctor.

"It's unclear whether this will be a true finding or not. Whether it is or isn't, we don't know if that will be sufficient to cause a warning label on Yaz itself," said Quintero.

The ingredient in question is drospirenone. The progesterone is not derived from testosterone, as found in other birth-control pills. Instead it's derived from a diuretic.

"Yaz was believed to maybe diminish some of the bloating with premenstrual syndrome, diminish some of the acne that was associated with this 'mother' compound," said Quintero.

How drospirenone raises the risk for blood clots is unclear. Federal health experts did agree Yaz and other widely used birth-control pills should carry stronger labeling.

Because Stephanie Fischer is now pregnant, she has to inject herself with blood thinners. From now on, she will always live the risk of a blood clot coming back.

"I have to live with this for the rest of my life," said Fischer.

The FDA also is reviewing research on clot risks associated with Johnson & Johnson's weekly Ortho Evra patch. The drug uses a different version of the female hormone progestin than Yaz.