Federal regulators and medical journals have found inadequate warnings of health risks of birth control pills that combine the estrogen ethinyl estradiol with the progestin drospirenone.
Women taking birth control pills using drospirenone as the progestin compound were more than 600% more likely to suffer blood clots than women who took no oral contraceptive, according to studies. Blood clots in the lungs - or pulmonary embolism - is a potentially fatal condition. Additionally, blood clots in the major veins in the body can lead to Deep Vein Thrombosis (DVT), a condition cited in several lawsuits already filed by users of Yaz, Yasmin and Ocella.
The Food and Drug Administration (FDA) has warned Bayer Healthcare Pharmaceuticals, the maker of Yaz and Yasmin, of its potential legal liability in marketing these drugs. (Ocella is distributed by Barr Laboratories, Inc.) Their television advertisements prompted a warning in October 2008. The regulators cited potentially deceptive and dangerous language to explain the products' uses and risks. They include:
Bayer recently agreed to terms requested by 27 different state Attorneys General as well as the FDA to air new advertisements. These commercials had the unapproved medical claims removed and the misinformation corrected. They also included more direct language regarding health risks.
Government regulators have looked at more than 50 reports of death from users of Yaz, Yasmin and Ocella from blood-flow-related causes. Some of these deaths were women of minor age who normally are at a low risk of such conditions.
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