Yaz, manufactured and promoted by Bayer HealthCare Pharmaceuticals as the leading oral contraceptive in the United States, has come under intense scrutiny by federal regulators and healthcare professionals. Yaz, which contains a combination of drospirenone, an anti-androgenic synthetic progestin and ethinyl estradiol, has been linked to the development of numerous life-threatening conditions. Clinical studies have revealed a direct linkage between Yaz and deep vein thrombosis, pulmonary embolism, heart attack, stroke, liver failure, pancreatitis and kidney stones.
Deep vein thrombosis is a condition resulting from the formation of a blood clot located in a deep vein, usually in the femoral or pelvic area. Once a blood clot is dislodged, it can travel to the lungs, causing a pulmonary embolism, which involves a blockage of a main artery in the lungs. Extreme low blood pressure can cause immediate collapse, coma and sudden death. Serious cardiovascular events, brain damage and liver failure have also been linked to Yaz. Recent studies have revealed that the progestin levels contained in Yaz can cause hyperkalemia, a condition in which elevated potassium levels in the blood can lead to cardiac arrest and sudden death.
Following the initial success of YAZ, Bayer launched costly television advertising campaigns promoting the drug as an effective treatment for hormone-related symptoms such as water retention, moodiness and acne outbreaks. Advertising spots also emphasized the effectiveness of Yaz for treatment of premenstrual dysphoric disorder and premenstrual syndrome. Bayer was issued strong warnings from the FDA to immediately discontinue confusing and misleading advertising campaigns.
The United States Food and Drug Administration, referred to as the FDA, issued approval for Yaz in 2006. By the end of 2008, Yaz became the best selling oral contraceptive in the U.S. Reports of life-threatening complications linked to Yaz prompted the FDA to issue several warnings to Bayer, including requirements that information concerning blood clots be placed on prescription labels. In April 2010, the FDA added a strong warning concerning the risk of thromboembolic disorders and vascular problems associated with Yaz. In May 2011, the agency announced the initiation of an in-depth safety review to determine the safety and efficacy of Yaz and potential links to blood clots. In September 2011, the FDA issued a drug safety communication in response to a study founded by the agency that observed and reported the side effects of Yaz on a target group of women. Findings led to an immediate warning issued to health care professionals and consumers concerning the potential risk of blood clots.
Since early 2009, numerous personal injury and product liability lawsuits have been filed nationwide alleging that Bayer intentionally concealed the known risks associated with Yaz. It is further alleged that Bayer engaged in fraudulent marketing and advertising campaigns, despite proven life-threatening complications caused by Yaz. Former FDA Commissioner Dr. David Kessler is currently working with a group of attorneys in formulating litigation strategies against Bayer. Dr. Kessler, in his review of investigative reports, cited internal studies conducted by Bayer in which results were falsified and misrepresented.
Bayer HealthCare Pharmaceuticals has announced its determination to mount aggressive defenses to allegations contained in pending lawsuits. The company continues to actively promote Yaz to health care professionals and consumers as a safe oral contraceptive and effective treatment for hormone-related symptoms. Although Yaz has not yet been recalled by the FDA, petitions are being circulated and the agency is pursuing action against Bayer.