FDA Study Finds Yaz, Similar Pills Increase Blood Clot Odds

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A U.S. Food and Drug Administration (FDA) study has concluded that the controversial birth control pills, Yaz and Yasmin, increase blood clot odds more than earlier generation oral birth control medications.

The FDA study looked at medical history for over 800,000 U.S. women from 2001 through 2007 who took a variety of oral birth control pills, said The Associated Press (AP). Women taking Yaz, on average, said the AP, experienced a 75% increased risk for developing a blood clot.

Earlier this week, NewsInferno wrote that an emerging study in the British Medical Journal (BMJ) also confirmed that birth control pills that contain so-called second generation synthetic progestins including drospirenone, desogestrel, or gestodene, doubled risks for blood clots when compared to medications manufactured with the older progestin, levonorgestrel. The study reviewed hormonal contraception patterns and first time venous thromboembolism (VTE) episodes for 8 million women with no prior record of blood clots or cancer prior to the study’s inception, said NewsInferno.

When compared to women not using oral contraception, the relative risk for a blood clot increased six-fold in women taking birth control pills with drospirenone, gestodene, or desogestrel and increased three-fold in women taking a hormonal birth control pill with levonorgestrel, said NewsInferno. All birth control pills, noted the AP, contain estrogen.

Drospirenone-containing oral contraceptives like Bayer’s Yaz and Yasmin, explained NewsInferno, can raise potassium levels, which can lead to hyperkalemia in some people. Hyperkalemia can, in turn, lead to potentially serious heart and health problems. Other similar oral contraceptives include Beyaz and Safyral, also by Bayer and Syeda, Loryna, Ocella, and Zarah, said the AP and Gianvi, said NewsInferno.

As NewsInferno mentioned this week, the FDA has not reached any conclusions about the drugs’ safety and has scheduled an advisory panel meeting for December 8 to discuss the issue. Bayer Healthcare said it “is currently evaluating this publication and cannot comment at this point in time,” according to the AP.

As both the AP and NewsInferno wrote, in 2009, the FDA ordered Bayer to run a corrective TV campaign after Bayer was accused of touting Yaz’ ability to prevent acne and premenstrual syndrome (PMS), treatments for which Yaz is not approved.

The FDA also reported increased complications in women using Johnson & Johnson’s Ortho Evra patch and Merck & Co. Inc.’s Nuvaring, which both combine estrogen and two newer generation synthetic hormones.

Some experts are concerned with why the FDA is approving expensive birth control treatments that appear to pose a variety of dangers. “At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market,” said Dr. Diana Zuckerman, president of the National Center for Women and Families, reported the AP. “With all these different birth control options, why take the most expensive one that can also kill you?” Dr. Zuckerman added.