FDA Considers Risk of Yaz Side Effects

On November 2, 2011, Janae Montgomery filed a lawsuit in the Superior Court of California. The lawsuit alleges that Montgomery suffered a pulmonary embolism as a result of Yaz and claims that Bayer Healthcare Pharmaceuticals, the manufacturer of Yaz and Yasmin birth control pills, is responsible. While Montgomery’s case is still in California courts, it has been stayed, possibly as a precursor to transfer to Yaz and Yasmin multidistrict litigation (MDL), which is headquartered in the Southern District of Illinois.

Yaz pulmonary embolism

In May 2011, the Food and Drug Administration (FDA) publically announced that drospirenone drugs, which include Yasmin and Yaz, were under review. The agency would evaluate side effects of these oral contraceptives, which reportedly have higher risks of pulmonary embolism than do other birth control pills.

Deep vein thrombosis (DVT) and venous thromboembolism (VTE) refers to blood clots in the deep veins, usually in the thighs and lower legs, dislodge and travel through the bloodstream. When a blood clot enters the lungs, it can cause pulmonary embolism. Find out more about Yaz pulmonary embolism.

Yaz side effects risk exposed by researchers

In October 2011, the FDA released results from its latest study of side effects (learn more) resulting from Yaz and Yasmin. The study collected data from four geographically diverse healthcare plans, and included information from more than 800,000 women. The FDA concluded that women who take birth control pills containing drospirenone exhibit a 1.5-fold increase in risk of blood clots and related conditions.

On October 25, 2011, a Danish study published in the British Medical Journal revealed similar findings. Dutch researchers studied more than one million women between 2001 and 2008, and recorded almost 3,000 reports of VTE during that period. They concluded that women taking oral contraceptives containing drospirenone have twice the risk of VTE as do women who take birth control pills with levonorgestrel, a type of progestin used in older oral contraceptives.

Yaz and Yasmin litigation pending throughout the country is currently in the discovery phase, and includes a coordinated effort by the Illinois MDL, a New Jersey mass tort, and consolidated litigation in Pennsylvania.

Yaz lawyers, including those representing Janae Montgomery, will likely use these recent studies as evidence for the prosecution.

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