Pharmaceutical Injuries - Yasmin and Yaz or Ocella

Have You Sustained Personal Injuries from Medications, Pharmaceuticals, or Chemical Exposure?

Yasmin and Yaz or generic Ocella

Recently, the FDA has warned that Yasmin and Yaz birth control pills can lead to increased levels of potassium in high-risk women, which can be dangerous. In particular, if a woman's potassium levels are too high, it can cause serious heart problems and other complications.  

Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare.  The generic brand Ocella is marketed and distributed by Barr Laboratories, Inc. The medicine works by disrupting a woman's natural menstrual cycle and providing a daily dose of hormones to regulate a new menstrual cycle.  Bayer AG has been involved in a few discussions with the Food and Drug Administration over questionable advertising campaigns seeming to suggest that Yasmin/Yaz has less side effects than other contraceptive medications.  Recent reports indicate that dangerous side effects could occur in women with preexisting conditions such as high blood pressure, diabetes, or obesity. 

If you or someone you know has suffered a heart attack, stroke, blood clots or seizure while using Yasmin and/or Yaz or the generic product Ocella birth control pills and you would like more information, the attorneys at Nationwide Law Group are available for a free consultation.

FDA Reports of Deaths among users of Yasmin and Yaz

From the first quarter of 2004 through the third quarter of 2008, well over 50 reports of death among users of Yasmin and Yaz have been filed with FDA.  These include numerous deaths with reported cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs) and stroke in women in their child bearing years.  Some of the deaths occurred in women as young as 17 years old.  Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering fatalities while using Yasmin or Yaz.

If you or a loved one suffered serious injury or if your loved one suffered death while using Yasmin, Yaz or the generic product Ocella, the attorneys at Nationwide Law Group are available for a free consultation.

Historical Development
Shortly after the introduction of birth control pills in the early 1960s, doctors found that women using the Pill had a higher risk of blood clots, heart attacks and strokes than women who were not using the Pill.  As a result, the various brands of the Pill were reformulated to reduce the amounts of estrogen. As the estrogen levels in the Pill were reduced throughout the 1970s and 1980s, the risk of blood clots, strokes, and heart attacks fell as well.   At the same time, new progestins were developed, which became known as the second generation progestins. These progestins, particularly levonorgestrel, when combined with the lower levels of ethinyl estradiol, helped reduce the risk of blood clots, strokes and heart attacks and made the Pill much safer for women. 
During the 1990s, new “third generation” progestins were developed with the hope that they would improve the safety of the Pill.  Unfortunately, the “third generation” progestins have been associated with a greater risk of blood clots in the deep veins (DVTs) and lungs (pulmonary embolism).  As a result of this increased risk of blood clots, products containing third generation progestins were required by the FDA to include a warning of the potentially increased risk of thrombosis. Yasmin and Yaz: Birth Control Pills with a “Fourth Generation” Progestin
While Yasmin and Yaz contain the same estrogenic compound that has been used in the lower dose Pill, the progestin in Yasmin and Yaz is unique. Yasmin and Yaz both contain drospirenone, a “fourth generation” progestin.  No other birth control pills contain drospirenone, except for a recently approved generic version of Yasmin and Yaz, marketed by Teva under the trade name Ocella.  In addition, a newly approved hormonal product for menopause called Angeliq contains drospirenone.
Because drospirenone is new, there is less data available to support its safe use as there are with the second generation progestins. Studies which were done before FDA approval, however, indicate that drospirenone has certain effects that are different than those of traditional second generation progestins and potentially more dangerous.  Specifically, drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high.  Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pauses or bradycardia.  If left untreated, hyperkalemia can be fatal.  In particular, if hyperkalemia disrupts the normal heart rhythms, the flow of the blood through the heart can be slowed to the point that it permits blood clots to form.  Blood clots in the heart can then lead to heart attacks, or break off and travel to the lungs where they can cause pulmonary embolus, or travel to the brain causing stroke. In addition, Yasmin and Yaz are marketed to reduce water retention and bloating often associated with premenstrual dysphoric disorder (PMDD).  The progestin component in Yasmin and Yaz, drosperinone, is a spironolactone analogue, which means it shares chemical properties with pills known as diuretics, or water pills. Diuretics are prescribed to reduce water retention and swelling. However, excessive loss of body fluids can lead to dehydration.  Severe dehydration can increase the risk of blood clots, by making the blood more thick and by causing constriction, or narrowing, of the blood vessels.  Severe dehydration also can lead to kidney damage. Reports of kidney damage and blood clots are included in the adverse event reports filed with the FDA concerning Yasmin and Yaz.

Please contact the attorneys at Nationwide Law Group if you or a loved one has been seriously injured by Yasmin or Yaz.

Lawsuits Filed
Recently, law firms have begun filing lawsuits against Bayer alleging that Bayer's oral contraceptives Yasmin and Yaz are defective and present an increased risk of injury to women. The women who filed suit suffered either deep vein thrombosis, pulmonary embolism, and/or stroke while taking these products. In addition, both Yasmin and Yaz have been associated with heart attacks and even death in young women.

The lawsuits allege that Bayer failed to warn women and their physicians of the increased risk of injury, while over-promoting the benefits of the drugs. In October of 2008, the Food and Drug Administration sent Bayer a warning letter objecting to its television ads claiming that Yaz has additional benefits compared to other oral contraceptives. The FDA's letter warned that Yaz actually has additional risks because it contains the progestin drospirenone. The warning prompted an agreement for Bayer to spend $20 million on corrective ads.

The attorneys at Nationwide Law Group are now reviewing claims involving dangerous birth control product cases. Submit your claim today!

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