As Yaz, Yasmin Safety Worries Mount, So Do Lawsuits

The litigation involving Bayer’s Yaz and Yasmin birth control pills continues to grow. According to a report from NJ.com, hundreds of lawsuits claiming Yaz and Yasmin caused young women to suffer blood clots and other health problems are pending in mass torts in New Jersey, Pennsylvania, California and Illinois.

Yaz and Yasmin were both brought to market by Berlex Labs. Yaz came on the market in 2001, and Yasmin followed five years later. In 2006, Berlex was acquired by Bayer. Backed by big marketing campaigns, it wasn’t long before both drugs were racking up big sales for Bayer. According to NJ.com, annual sales of Yaz reached $361 last year. Annual sales of Yasmin peaked in 2008 at $329 million, but have declined somewhat since then.

Yaz and Yasmin proved popular with doctors and patients. According to NJ.com, they were considered an advance over older birth control pills because they were taken for 24 days rather than the usual 21, resulting in less hormonal fluctuation. In the words of one plaintiffs’ attorney interviewed by NJ.com, it wasn’t long before Yaz “was the pill most women were getting.”

But early on, the drugs raised safety worries. As we’ve reported previously, both Yaz and Yasmin are made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients, which may result in potentially serious heart and health problems.

A year after Yasmin went on the market, the nonprofit consumer advocacy group Public Citizen placed the drug on its list of “Do not use pills” because of concern over drospirenone side effects, according to NJ.com. The group also said that Yasmin did not provide any more benefits compared to older pills that were less likely to cause blood clots and other dangerous side effects.

Since then, concerns about drospirenone have only grown. Just recently, two studies that appeared in The British Medical Journal reported a two- to three-fold greater risk of venous thromboembolic events (VTEs) – including life threatening deep vein thrombosis (DVT) and pulmonary embolism (PE) – in women using oral contraceptives containing drospirenone rather than levonorgestrel. The publication of those two studies prompted the U.S. Food & Drug Administration (FDA) to announce in May that it was evaluating the safety of birth control pills made with drospirenone.

As we’ve reported previously, earlier studies examining the risk of blood clots and drospirenone contraceptives have had conflicting results. Two postmarketing studies required by the FDA or European regulatory agencies did not report any difference between birth control pills containing drospirenone and those containing levonorgestrel. However, two other studies published in 2009 reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products. Information regarding all four of those studies is noted on the labels of drospirenone birth control pills.

Yaz and Yasmin lawsuits are alleging that Bayer did not provide adequate warnings about the health risks associated with the drugs. They blame the contraceptives for causing blood clots, heart attacks, strokes and, in some cases, sudden deaths, NJ.com said.

But while the litigation surrounding both drugs is massive, and will likely continue to grow, it’s doubtful the lawsuits will give Bayer a reason to pull the drugs from the market, Sidney Wolfe, director of Public Citizen’s Health Research Group, told NJ.com.

“If companies think they will make more money by continuing to sell a drug, they will,” Wolfe said. “That’s the calculus, if they make more money than they will lose in litigation.”

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