The combination of contraceptive drugs Drospirenone and ethinyl estradiol has been associated with a number of Drospirenone side effects. Bayer, the manufacturer of oral contraceptives containing the Drospirenone drug is now facing thousands of Drospirenone lawsuits.
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Oral contraceptives such as Yasmin and Yaz, Safyral and Ocella contain the synthetic progesterone called drospirenone, which other and traditional oral contraceptives do not contain. The following contraceptives contain drospirenone:
Drospirenone Side Effects
Drospirenone and Venous Thromboembolism (VTE). Drospirenone has also been associated with venous thromboembolism (VTE)—blood clots that form within a vein. A number of studies, most recently published in the BMJ (October 2011), suggest that women on these pills (listed above) containing one of the newer types of progestogen hormone (drospirenone, desogestrel or gestodene) have double the risk of VTE than women on pills containing an older progestogen (levonorgestrel).
Drospirenone and Deep Vein Thrombosis (DVT). Drospirenone has also been linked to deep vein thrombosis (DVT), which is a blood clot that forms in a deep vein, and pulmonary embolism—blood clots in the lungs. New research published in the Canadian Medical Association Journal (November, 2011) involving about 330,000 women in Israel found that women taking birth-control pills containing the drospirenone were as much as 65 per cent more likely to develop venous thromboembolism than women taking older generations of the pill.
Drospirenone and Gallbladder disease. It is also associated with gallbladder disease, particularly in young women.
As early as November 2009 the FDA had reports of 993 cases of pulmonary embolism (PE), 487 cases of DVT and 229 cases of other blood clots for Drospirenone and ethinyl estradiol combined.
The FDA and Drospirenone
The agency announced that a final report of its study that evaluated the risk of blood clots in users of several different hormonal contraceptives will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee on December 8, 2011.
In November 2011, Health Canada announced that its review found 1.5 to 3.0 times the risk of blood clots in women who used contraceptives that contain drospirenone. The health agency said that labels have been updated to include the warning and recommended that health care professionals consider the risks and benefits of birth control products that contain drospirenone when determining which contraceptives to prescribe.
According to the Canadian Broadcasting Corp (CBC), by January 2011 more than 4,000 women in the US have taken legal action against Bayer and more than 800 women have joined a class action lawsuit in Canada.
Drospirenone lawsuits against Bayer—both involving side effects and deceptive marketing of Yaz and Yasmin--allege that the drug company:
- Underplayed the risks associated with the products and overstated their approved uses in an effort to mislead users of Yaz and Yasmin into believing that the drugs were safe.
- Failed to properly research the medication.
- Failed to recall the drug after post-marketing reports demonstrated that the risk of potentially life-threatening side effects of Yasmin and Yaz outweighed potential benefits that could be achieved via other available oral contraceptives.
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