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    8
    Dec
    2011
    5:34pm, EST

    FDA panel: Add stronger warnings to birth control labels

    By Associated Press

    Federal health experts say Yaz and other widely-used birth control pills should carry stronger labeling information that emphasizes recent evidence that the drugs have a slightly higher risk of blood clots than older drugs.

    The Food and Drug Administration's panel of experts voted 21-5 Thursday that labeling on the popular drugs made by Bayer is inadequate and should be updated with information from several recent studies.

    Yaz, its predecessor Yasmin and related prescriptions use a manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone.

    Panelists spent more than nine hours discussing often conflicting data on the blood clot risk of drospirenone-containing drugs compared with older medications. While the group disagreed on the quality of the evidence, the overwhelming majority said it should be made more explicit in the label, including the potentially fatal nature of blood clots.

    "Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

    In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority opinion amounts to a vote of confidence that the drugs should remain on the market, though well over a third of panelists voted against the drug's overall benefit, especially given numerous other oral contraceptives available.

    "I can see no real group of patients that this drug benefited over existing alternatives," said Mark Woods of New York University School of Medicine. "Without any clear benefit, and given the potentially catastrophic risk, I voted no."

    Approved in 2006, Yaz grew into the best-selling birth control pill in the U.S. by 2008, backed by hundreds of millions of dollars in TV and magazine advertising that emphasized its ability to clear up acne and other hormonal side effects. But prescriptions have fallen more than 80 percent in the last two years amid safety concerns and a consumer backlash against misleading advertisements that regulators said overstated the drug's benefits.

     

    Related stories:

    Teen says blood clot after Yaz destroyed her life

    FDA favors more risk info on newer birth control pills

     

    © 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

    64 comments

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    Explore related topics: fda, birth-control, contraceptives, womens-health, sexual-health, yaz
  • 8
    Dec
    2011
    3:19pm, EST

    Teen says blood clot after taking Yaz destroyed her life

    Courtesy of Lynsey Lee

    Lynsey Lee, 19, was diagnosed two years ago with a blood clot in her left lung, months after she began taking the birth control pill Yaz.

    By Kimberly Hayes Taylor

    Lynsey Lee hoped Yaz would relieve her severe menstrual cramping and pelvic pain, so she began taking the birth control pills when she was only 16. But, instead of getting better, she started experiencing extreme mood swings, nausea and even more pain.

    “I got really, really sick,” says Lee, now 19, of White Bluff, Tenn. “I was just constantly throwing up, and it was getting hard to breathe sometimes.”

    Then, she started having unbearable chest pains that sent her to the hospital what seemed like every few days. Doctors initially couldn’t figure out what was wrong. “They kept telling me that it was just my body getting used to the medicine,” she says. “Finally, [when I was 17] I just stopped taking it.”

    Later that year, after numerous medical exams, doctors diagnosed a blood clot lodged in her left lung. During one emergency room visit, doctors asked Lee what would become a life-changing question for thousands of young women like her: “Have you ever taken Yaz?”

    Now, she is among the more than 10,000 American women who have filed class action lawsuits or claims against the German pharmaceutical giant Bayer, which makes Yaz, a popular birth control pill. Thousands more claims are expected. In documents released Tuesday, the Food and Drug Administration raised questions about conflicting evidence about the risks of taking Yaz and other similar pills, including life-threatening blood clots, and said warning information should appear on labels for doctors and patients.

    Thursday, the FDA's panel of outside experts voted 21-5 that current labeling on the medications isn't enough and should be updated with more information on the risks. But that news comes too late for Lee.

    “I wish I had known before,” she says. “I never would have taken Yaz.”

    A representative from Bayer said the company did not have an immediate response.

    The side effects of taking the birth control pill that was touted as having fewer side effects than others have destroyed her life, Lee says.

    She had been the captain of the high school dance team, but Lee said after she began developing symptoms, she had to sit on the sidelines because she couldn’t catch her breath. She ended up missing the second half of her senior year in high school, including her senior prom. But, she says, her biggest sacrifice was giving up a full dance team scholarship to Vanderbilt University -- all because of the blood clot that doctors can do little about.

    Removing it is too dangerous, they say; Lee takes blood thinners and hopes the clot will dissolve and work its way through her system.

    Today, Lee says, she lives with pain and fatigue and isn't strong enough to work. Instead of attending college classes to earn a business degree, Lee makes weekly visits to her doctor for monitoring.

    She’s hired Oklahoma City attorney Noble McIntyre, a member of the attorney group The Injury Board, which advocates for patient safety. McIntyre represents 60 Yaz victims and partners with another firm representing 600 Yaz clients.

    “She’s missed out on her youth, and she missed out on a scholarship that probably was worth $200,000,” McIntyre says. “We try to give our clients hope that somebody understands what they are going through. We’re trying to communicate with the defendant what these women, through no fault of their own, have experienced. She lost her prom. She lost her freedom, something so valuable to people, because she’s mostly confined to her home.”

     

    Story: FDA panel: Add stronger warnings to birth control labels

    Lee says she’s depressed because her compromised health keeps her from living a normal teenager’s life. “I cry a lot,” she says. "It just hurts so much."

    She dreams of someday opening a pastry shop and bakes cakes now for her family when she’s up to it. Shehas helped coordinate fundraising efforts for the Ronald McDonald House and the St. Jude Children’s Research Hospital in Memphis. But she's still not sure what her future may hold.

    “I don’t pray to get better because it’s in [God’s]  hands,” she says. “I pray for happiness.  I pray for others in this world that have it much worse than I do.”

    Read more from Vitals:

    Plan B won't be available OTC to younger teens, HHS says

    Sick'nd by Chick'n? Food police take the fun out of fungus meat

    168 comments

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Kimberly Hayes Taylor

Kimberly Hayes Taylor is an independent health journalist, author and speaker who frequently contributes to msnbc.com and TODAY.com. She has been a reporter at several newspapers including The Detroit News, Minneapolis Star Tribune, The Hartford Courant, USA Today and the Louisville Courier-Journal. Her work has been translated into other languages, and has appeared in dozens of American and international newspapers. Taylor’s articles also …

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