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Yaz, Yasmin Blood Clot Risk Warnings Need to be Stronger, FDA Advisors Say

Dec 9, 2011 | Parker Waichman LLP

Two U.S. Food & Drug Administration (FDA) committees voted overwhelmingly yesterday to recommend stronger label warnings for Yaz, Yasmin and similar oral contraceptives regarding their possible association with blood clots.  The outside advisors voted 21-5 that current label warnings for Yaz, Yasmin and other pills made with the progestin, drospirenone, are inadequate and need to include clearer information about data that have linked the  pills to a higher risk of blood clots.

The FDA is not legally obligated to follow the recommendations of its outside advisory panels, but it usually does so.

According to a report from Newsinferno.com, a total of five large studies have found evidence that drospirenone birth control pills pose a higher risk of blood clots compared to those containing an older form of progestin. Most recently, an FDA-Funded study that involved 800,000 American women taking some birth control between 2001 and 2008 found that those taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives. Only two large studies, both funded by the maker of Yaz and Yasmin, have failed to find a higher risk.

The conflicting studies are noted on the labels for Yaz, Yasmin and similar birth control pills.   But the FDA's advisors found those to be confusing, and some members were bothered only Bayer-sponsored studies seemed to find Yasmin equally safe as other birth control pills, according to a Reuters report.

"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.

Some patient advocates argued for the advisors to recommend even more drastic action, Reuters said, asserting they should be pulled from the market entirely.

"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.

However, the FDA advisors did not agree, and voted 15 to 11 that the benefits of the birth control pills still outweigh their risks.

According to a report from The New York Times, the advisors stopped short of recommending  that the labels for Yaz, Yasmin and similar contraceptives warn that they are more dangerous than other birth control pills. The experts also suggested that the labels note that the evidence about blood clots is conflicting.


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