When the birth control drugs Yaz and Yasmin came to the market, they quickly rocketed to popularity, becoming the leading birth control pill on the market and generating billions of dollars per year in sales for Bayer, the drug company that makes it. Early ads that claimed Yaz not only was effective as a birth control drug, but also helped with acne and severe PMS; tens of millions of women switched to Yaz. But, as ABC News reported in December, those claims were criticized by the FDA and now studies are indicating that Yaz might actually be more dangerous than other birth control drugs on the market.
Specifically, as compared to other birth control drugs, some studies indicate that Yaz and Yasmin present an increased risk of blood clots. Blood clots can be extremely dangerous—and even life threatening. A blood clot that forms deep in a deep vein in the body—known as deep vein thrombosis—can break loose and travel to the lung, causing a pulmonary embolism.
This is an issue that caught the FDA’s attention and in May of last year the agency issued safety information to the public and undertook a more serious review of the drug’s safety and labeling information. The concerns relate specifically to birth control medications containing the drug drospirenone, a synthetic form of progestin that is used not only in Yaz and Yasmin but in other brand name and generic pills as well.
While all birth control drugs present some risk of blood clots, the FDA notes that there are several studies that indicate that risk is higher for women who take birth control containing drospirenone. By September of last year, the FDA had arrived at a preliminary finding that drospirenone-containing birth control pills presented a 1.5-fold increase in the likelihood of developing blood clots. Then, in December, an FDA panel found that the labels on these drugs do not adequately communicate the risks of blood clots.
Just how big is the risk? The research indicates that the rate of blood clots for women taking regular birth control pills—that do not contain drospirenone—is 6 in 10,000. The rate for women taking drospirenone-containing pills is 10 in 10,000. As reported in the New York Times, another study that examined over a million women in Denmark found the risk of blood clots to be double for women on drospirenone-containing drugs. That increased risk comes with no added effectiveness for preventing pregnancy. And maybe even no added benefit over traditional birth control drugs for treating acne or PMS.
Now questions are beginning to surface about what Bayer—the maker of Yaz and Yasmin—knew about these risks when they marketed and sold the drug to millions of women. There are also serious questions about what information Bayer did and did not disclose to the FDA when it was seeking approval for the drug. More than 10,000 law suits—alleging harm to women, including nearly 100 deaths—have already been filed against Bayer over this issue.
A partner with Inserra & Kelley, Attorneys At Law since 1993, Craig Kelley focuses on personal injury law with a large emphasis on motorcycle and bicycle related cases and claims with the goal of first helping clients heal and then getting speedy resolution of their disputes.