YAZ® & Yasmin® / Ocella

Yaz® and Yasmin® are popular prescription birth control pills taken orally to prevent pregnancy. The generic version of Yasmin is called Ocella. But if you have found this information, you are likely among the women who have experienced serious adverse reactions to the contraceptives.

Munley, Munley & Cartwright, P.C., is a Pennsylvania law firm that represents victims and consumers in personal injury litigation, including pharmaceutical injuries. The firm has more than 40 years experience in practicing personal injury law. To contact our family of lawyers, call 1 800-318-LAW1 or contact us through our online forms.

Yaz is one of the top selling oral contraceptive in the United States.  But the U.S. Food and Drug Administration sent Bayer Healthcare Pharmaceuticals, Inc. a warning letter in 2008, citing the company for running two misleading television ads. The FDA said the two 60-second television commercials misbranded the drug, overstated its benefits and minimized serious side effects.

• The FDA noted that ads for Yaz completely omitted the fact that the drug had not been evaluated for treatment of premenstrual syndrome (PMS) and was only approved for treating symptoms of severe premenstrual depression, a more serious condition known as premenstrual dysphoric disorder (PMDD).
• In addition, the FDA said the ads overstated a side benefit by suggesting the drug was helpful in treating all acne when it was only approved for treating moderate acne.

Under an agreement with the FDA and 27 state attorneys general, Bayer in February 2009 agreed to a $20 million ad campaign to correct previous marketing of Yaz and also agreed to submit future Yaz ads for federal screening for six years.

According to The New York Times, Bayer has been served with 74 lawsuits as of September 2009 by women who claim they have developed health problems after taking Yaz or Yasmin.

Yaz and Yasmin, like other oral contraceptives, are associated with an increased risk of heart attack, stroke, blood clots in the legs and lungs, gallbladder disease, liver cancer and hypertension. Yaz and Yasmin carry a boxed warning—the FDA’s strongest warning label— that patients who smoke and use oral contraceptives are at greater risk of cardiovascular problems.

Yasmin has been on the market since the FDA approved it in 2001. In 2003, the FDA sent a warning letter to Berlex Laboratories, complaining that its ads for Yasmin implied the pills were superior to other oral contraceptives and for minimizing risks associated with the drug.  Bayer acquired Berlex in 2006 and now markets Yasmin. In 2006, the FDA approved Yaz, which contains a lower dosage of estrogen.

Both Yaz and Yasmin contain a synthetic progestin called drospirenone that may increase potassium levels, a condition called hyperkalemia.  While potassium is an essential nutrient in the body, too much potassium can affect the nervous system and cause serious heart problems, such as irregular heartbeats and cardiac arrest.

Individuals who have experienced serious adverse reactions from taking Yaz  or Yasmin should contact our office to learn your legal rights and options. You can call the Munley, Munley & Cartwright law firm from anywhere in the United States toll free at 877-421-9173 for a free consultation.

Sources:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

http://www.nytimes.com/2009/02/11/business/11pill.html?_r=1&scp=1&sq=pill%20that%20promised%20too%20much&st=cse

http://www.nytimes.com/2009/09/26/health/26contracept.html?_r=2&pagewanted=1

http://berlex.bayerhealthcare.com/html/products/pi/fhc/Yasmin_PPI.pdf?WT.mc_id=www.berlex.com