Yasmin and Yaz

The popular birth control pills Yasmin and Yaz, both manufactured by Bayer, have been found in clinical studies to cause a higher rate of blood clot injury than other oral contraceptives on the market. At least 300 product liability lawsuits against Bayer have been filed across the U.S. alleging injuries, including at least 50 deaths, attributed to the drugs.

Conditions such as deep vein thrombosis (blood clot in the legs), pulmonary embolism (blood clot in the lungs), heart attack, stroke or even death have been associated with the drugs, according to allegations in the lawsuits and the Federal Food and Drug Administration. Pancreatitis, kidney failure and gall bladder disease were also among noted side effects, as were headaches, weight gain, depression, cramps, panic attacks and many more serious health concerns.

When compared with other birth control pills, the elevated risk of blood clot with Yasmin and Yaz, according to University of Copenhagen studies, was likely due to use of a synthetic progestin called drospirenone. Drospirenone is not found in any other birth control medication; the chemical is unique to Yaz, Yasmiin, and their generic equivalent, Ocella. Birth control pills (BCPs) containing other progestins, such as levonorgestrel, had a lower chance of causing blood clots, studies found.

BCPs were introduced in the 1960s. Since then, four main types of progestin have been used. Drospirenone, a fourth-generation progrestin, is the newest and therefore there is little publicly available data to support claims that the hormone is safe when used in combination with estrogen to prevent pregnancy, as it is in Yaz and Yasmin.

The pending product liability lawsuits claim that drospirenone increases potassium levels, which may disrupt heart rhythms or slow down blood flow, allowing the formation of blood clots.

In 2008, Yaz accounted for over 17 percent of the birth control pill market and Yasmin for an additional 11 percent market share. This is the top-selling pharmaceutical line for Bayer, with an estimated $382 million in sales in 2008 alone. Bayer has marketed the drugs heavily, positioning them as not only intended for pregnancy prevention but for lifestyle benefit – to treat acne and lessen premenstrual dysphoric disorder (PMDD, a severe form of premenstrual syndrome) symptoms. The television advertisements often drowned out the narrator’s listing of known side effects with loud background music.

Bayer’s aggressive marketing campaigns have been called “deceptive” and “misleading” by the FDA. Bayer was forced by the FDA and several state attorneys general to offer a $20 million corrective advertising campaign to clearly state the known side effects. The company also agreed to let the FDA screen future ads before they can be aired.

Lawsuits filed across the U.S. have accused Bayer of unlawfully promoting Yaz and Yasmin, misleading investors about the value of the company, and concealing the drugs’ increased risks of blood clot injury. The 50 deaths attributed to the two drugs by the FDA occurred between the first quarter of 2004 and third quarter of 2008. The deaths involved women as young as 17 who suffered heart attacks, strokes or pulmonary emboli after taking Yaz or Yasmin. Elevated levels of potassium in the blood were frequently reported.

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