YAZ BLOOD CLOT RISKS

PANEL VOTES THAT LABELS FOR YAZ, YASMIN, AND RELATED MEDICATIONS NEED CHANGES TO BETTER REFLECT BLOOD CLOT RISKS

Advisers to the Food and Drug Administration met on December 8, 2011 to review the science behind Yaz and its class of birth control pills and voted that the drugs’ prescribing label should be changed to better reflect the dangers to women who take the medications of getting a blood clot.

The advisers voted 21-5 that the information labels for the class of pills should be changed to more clearly reflect the potential for blood clots as a side effect of the medications.
The FDA does not have to follow the panels’ advice.

The clarity of the language and the way the label communicates the information formed part of the discussion about how the label should be updated to warn women who take the medications.

One interesting study that formed part of the review of the relevant scientific data found that women taking drospirenone-containing contraceptives were 74 percent more likely to experience clots than women who take older hormonal contraceptives.

Drospirenone is similar to the naturally occurring female hormone progesterone.

The FDA acknowledges that the newest generation birth control pills may raise the risks of blood clots.

Bayer’s Yaz and Yasmin generated about $1.5 Billion in sales for the drugmaker last year as its second-best selling product. This is less than the $1.8 billion it had produced in 2009. Teva Pharmaceutical Industries LTD. began selling a generic version of Yaz in May 2010.

Yaz was approved for sale in the U.S. in 2006 and has a lower does of estradiol than Yasmin, which began sales in the U.S. in 2001.

Yas and Yasmin and similar medications combine drospirenone, a synthetic versions of the female hormone progesterone, with estradiol, a form of the female hormone estrogen.

Bayer faces around 10,000 or more lawsuits over injuries allegedly caused by the medications.

Lawyers have cited FDA reports on at least fifty deaths of those taking the medications between 2004 and 2008.

Some doctors state that some women prefer the new birth control medications such as Yaz because Yaz and Yasmin and related drugs allegedly help control acne and premenstrual dysphoric disorder.

Some womens’ health advocates are so concerned by Yaz and Yasmin that they believe the medications should be taken off the market since there are safer options available.

© 2012 DrugRxRecall.com
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