Yaz Blood Clot Risk - Consumer Justice Foundation

Yaz Blood Clot Risk

Written by Faith Anderson on April 12, 2012
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Yaz and Yasmin Linked to Blood Clots

The active ingredient in Yaz and Yasmin is drospirenone, a synthetic progestin which can prevent pregnancy by suppressing ovulation, either when used alone or in combination with an estrogen component. Yasmin garnered FDA approval in 2001 and was the first birth control pill on the market to use drospirenone. Yaz was approved in 2006 and quickly became one of the best-selling oral contraceptives in the United States, with $781 million in sales in 2009 alone. Yaz is now considered the second best-selling product made by Bayer, with $1.56 billion in global sales.

Two recent studies published in the British Medical Journal found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier generation oral contraceptives. According to the European Medicines Agency, such birth control pills carry a higher risk of venous thromboembolism, and warning labels should be updated accordingly. Previous safety communications issued by the FDA concerning the risk of blood clots in patients using drospirenone products were posted on May 31, 2011, September 26, 2011 and October 27, 2011.

FDA Panel Finds Yaz Side Effect Label Inadequate

The new FDA announcement comes after a panel of experts that advises the FDA called for stronger labels on drospirenone-containing pills in December, voting 21-5 that the current labels did not adequately reflect the risks and benefits. The panel was divided on the question of whether the benefits of drospirenone-containing birth control pills like Yaz outweighed the risks, with 15 voting “yes” and 11 voting “no.” Upon completing its review of recent epidemiological studies regarding the risk of blood clots in women taking drospirenon-containing birth control pills, the FDA announced the label change, warning that healthcare providers should consider the risks and benefits of drospirenone-containing pills like Yaz and a woman’s risk of developing a blood clot before prescribing these drugs.

The FDA has pointed out that studies examining the risk of blood clots with birth control have shown mixed results. “The revised drug labels will report that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products […] whereas other epidemiological studies found no additional risk.” In its own study, the FDA found that between three and nine out of every 10,000 women taking pills with drospirenone would get a blood clot in any given year, compared to between one and five out of every 10,000 women not taking a drospirenone-containing oral contraceptive. These blood clots can be fatal if they break loose and travel to the heart, brain or lungs.

Posted Under: FDA - Food and Drug Administration
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