Yaz, Yasmin, Ocella Birth Control Drugs
Yaz, Yasmin and Ocella are known as combination oral birth control drugs because they contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone).
Yasmin was approved by the FDA in 2001 for both birth control and treatment of Premenstrual Dysphoric Disorder (PMD) and later Yaz was also approved for treatment of severe acne. The highly popular oral contraceptives Yaz, Yasmin, and Ocella have an increased risk of serious, life-threatening injuries including blood clots, strokes and heart attacks. All serious product liability concerns.
Dangerous Side Effects
Yaz and Yasmin are both made with a type of progestin called Drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Adverse Events reported to the FDA involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.
On September 26, 2009, the New York Times reported that there were increasing concerns over the safety of Yaz and Yasmin. The article pointed out that two separate Dutch and Danish studies published in The British Medical Journal found a higher risk of venous blood clots for women taking newer progestins, including drospirenone. The FDA is currently reviewing the safety of birth control pills with a study designed to identify the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives.
In summary, the oral contraceptive Yaz, Yasmin and Ocella have both been linked to serious, life-threatening injuries including:
- Heart attacks
- Blood clots
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Gallbladder Disease
FDA Takes Corrective Action
Yaz is the top-selling oral contraceptive in the United States. In 2008, Yaz and Yasmin generated approximately $1.8 billion for Bayer. These sales were achieved through a marketing campaign that presented the medications as more than mere birth control pills and touted them as treatments for Premenstrual Dysphoric Disorder, Premenstrual Syndrome and moderate Acne. Bayer Corporation and other defendants have been warned at least three times by the U.S. Food & Drug Administration (FDA) regarding their misleading television advertisements, which overstated the efficiency of Yaz or Yasmin and minimize the serious risks associated with the drugs.
Under a federal law that prohibits promotion of drugs for uses not approved by the FDA, Bayer was ordered to mount a $20 million advertising campaign to correct its previous misleading Yaz advertisements.