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Yasmin, Yaz and Ocella

National Yasmin, Yaz and Ocella Litigation Attorneys

Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare.  The generic brand Ocella is marketed and distributed by Barr Laboratories, Inc. They are combination oral contraceptives [COCs], meaning that like most birth control pills, they contain an estrogenic component and a progestational component.  These steroidal components work together in COCs to suppress ovulation, fertilization and implantation and thus prevent pregnancy. Yasmin and Yaz were approved for marketing in 2001 and 2006, respectively.

Historical Development of COCs

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, while the “third generation” progestins (gestodene and desogestrel) appeared to have less androgenic activity, they 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, ethinyl estradiol that has been used in the lower dose Pill, or COCs, for decades, 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 are not decades of 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 experienced Yasmin attorneys at Burg Simpson Eldredge Hersh & Jardine, P.C.if you or a loved one has been seriously injured by Yasmin or Yaz.

 

This website is sponsored by Burg Simpson Eldredge Hersh & Jardine, PC.