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Attorney discusses Yasmin/Yaz Label Change, Recent Studies and More

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Austin, TXShortly after Bayer added warnings to the labels of Yasmin and Yaz in Europe, the FDA in April 2010 forced the pharmaceutical company to place stronger warnings on its birth control pill in the US. So far, not much has changed: Bayer continues to state that the risk of blood clots is comparable to that of other birth control pills. "We are concerned that this new warning won't be strong enough," says Kristin Giaquinta Schoen, an attorney with Hissey Kientz LLP.

"Two studies published in the British Medical Journal last year reported that women taking Yaz and Yasmin are twice as likely to get blood clots," says Schoen, whose client suffered a pulmonary embolism and DVT while on Yaz.

"This 27-year-old woman was hospitalized for several days; she had no other risk factors, no family history of blood clotting. She will likely be on blood thinners for the rest of her life. This woman previously used other forms of oral contraceptive pills not containing the hormone drospirenone, the synthetic progestin found in Yaz and Yasmin, which strongly suggests that drospirenone played a factor in venous thromboembolism, or blood clotting.

"Cases like this illustrate the need for stronger warnings labels to alert women of the health risks posed by Yaz and Yasmin. Thousands of otherwise healthy young women have had their lives permanently altered because they were unaware of the dangers they subjected themselves to by taking Yaz or Yasmin."

Schoen says she is hopeful that the new warning label will be stronger in the US than that in Europe. However, Bayer is questioning the methodology of the British studies and guessing the results were inconclusive. "The terminology Bayer is using is that the risk is comparable to other birth control pills, which isn't reassuring."

Bayer is expected to include on the new label two studies, both sponsored by the company, that concluded that the risk of blood clots in Yasmin users is comparable to that found for women who use second generation oral contraceptives—historically safer pills that contain the hormone levonorgestrel.

But many disagree—including Yasmin and Yaz attorneys, national consumer group Public Citizen, a number of European health officials and, of course, thousands of Yasmin and Yaz users.

Germany's Federal Institute for Drugs and Medical Devices reported that only 20 out of 100,000 women who take a second generation oral contraceptive develop thromoembolic symptoms. But women who take the newer third-generation pills, which contain the hormone drospirenone, like Yasmin and Yaz, are at twice the risk, with 35 to 40 women out of 100,000 experiencing thromboembolic effects each year.

Public Citizen has placed Yasmin on its "worst 10 drugs" list. "Women that use these pills have a doubling in their risk of developing blood clots…there is no medical reason that you should be using Yasmin rather than one of the older pills containing the progestins norgestrel, levonorgestrel or norethindrone," writes the consumer group.

Yet Bayer claims that Yasmin and Yas are safe and that consumers should disregard the British Medical Journal articles ("Hormonal contraception and risk of venous thromboembolism: national follow-up study" and "The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study").

And no wonder: despite the more than 1100 lawsuits filed by women after using Yasmin and Yaz, these drugs remain a top seller for Bayer, with over $1.64 billion in sales for 2009 alone.

"Although more than 1,100 lawsuits have been filed by women who were injured after using Yaz or Yasmin, this litigation is only in its infancy," says Schoen. "In addition to lawsuits filed in state courts in California, New Jersey and Pennsylvania, hundreds of Yaz and Yasmin lawsuits have been consolidated in a Multi-District Litigation in Illinois. Women who have suffered blood clots or other side effects of these birth control pills may still be eligible to file a lawsuit and should contact an attorney to learn if they qualify."


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