FDA Issues a Warning Letter to Bayer over the Serious Health Risks Associated With Popular Oral Contraceptives Yaz and Yasmine

Lawsuits against Bayer, the manufacturer of Yaz and Yasmin, may soon reach thousands. Yaz and Yasmin are being targeted by the Food and Drug Administration (FDA) because the organization determined the birth control pills are both dangerous and less effective than originally advertised.

Yasmin and Yaz are both low estrogen oral contraceptives. Yasmin was approved in the U.S. in 2001, while Yaz – which contains even less estrogen – was approved in 2006. Together, the pills generated approximately $1.8 billion for Bayer HealthCare last year alone. According to The New York Times, Bayer has positioned them as the “go-to drug brands for women under 35.” Yaz, which is the top-selling birth control pill in the U.S., has been marketed by Bayer as “a quality-of-life treatment to combat acne and severe premenstrual depression.”

However, according to several FDA reports, the oral contraceptives have been linked to a number of health risks related to blood clots, and thousands of young women have suffered debilitating injuries, including deep vein thrombosis (DVT), stroke, heart attack, pulmonary embolism and even death.

YAZ contains a synthetic type of progestin called drospirenone, which can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood. Hyperkalemia may result in potentially serious heart problems, as well as other medical conditions, including kidney failure.

Most recently, the FDA has issued a warning letter to Bayer HealthCare Pharmaceuticals, Inc. regarding what it termed as “misleading” advertising spots that it found “particularly troubling” because they failed to communicate important health risk information. The FDA claims that the ads suggest that Yaz and Yasmine are safer than concluded in clinical trials.

In the meantime, Bayer has refused to recall the drugs, claiming the pills do not pose any additional health risks than any other product containing estrogen.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s premier personal injury attorneys. AWKO Law has succesfully tried a number of defective drug cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your right for compensation.