History of Yasmin, Yaz and Ocella
National Yasmin, Yaz and Ocella Litigation Attorneys
Yasmin and Yaz are birth control pills manufactured by Bayer Healthcare. 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 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. If Yasmin or Yaz lead to excessive loss of fluids resulting in dehydration, women using these products can be at an increased risk of blood clots.
FDA Reports of Deaths among users of Yasmin and Yaz
During the brief time that Yasmin and Yaz have been sold in the United States, hundreds of reports of injury and death have been filed with the FDA in association with the use of these products. In fact, in less than a five year period, 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.
Over-Promotion of Yasmin and Yaz
Yasmin and Yaz were originally manufactured and distributed by Berlex Laboratories, which was purchased by Bayer Healthcare in 2006. Prior to the sale to Bayer, on July 10, 2003, FDA issued a Warning Letter to Berlex Laboratories, ordering it to immediately discontinue a misleading television ad for Yasmin. In this ad, the company promoted Yasmin's fourth generation progestin by stating, "Ask about Yasmin, and the difference a little chemistry can make. The FDA objected to the characterization that drospirenone was a benefit compared to the progestin used in other COCs, stating, "FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone . . . Further, FDA found that the advertisement "fails to communicate that the potential to increase potassium is a risk or that "increased serum potassium can be dangerous.
Then again on October 3, 2008, FDA issued a Warning Letter to Bayer, for another false and misleading advertisement concerning Yaz. FDA found that Bayer was attempting to broaden the indication for Yaz to include PMS (premenstrual syndrome), as opposed to the less serious condition of PMDD (premenstrual dysphoric disorder.) FDA reiterated that the marketing was misleading because it promoted YAZ for medical conditions beyond the limits of the FDA approval. But also, FDA held the ad misleading because it failed to disclose that "YAZ has additional risks because it contains the progestin, drospirenone . . . which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems.
Contact Burg Simpson
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 experienced drug liability attorneys at Burg Simpson are available for a free consultation.
Burg Simpson is a national law firm with offices in Denver, Colorado, Cincinnati, Ohio and Cody, Wyoming. Burg Simpson attorneys are very experienced in pharmaceutical litigation involving birth control products. Burg Simpson shareholders Michael S. Burg and Janet G. Abaray are currently the National Lead Counsel for Plaintiffs in the Ortho Evra Products Liability Litigation, which involves injuries and wrongful death alleged due to blood clots caused by the Ortho Evra Birth Control Patch. In addition, Burg Simpson attorneys hold leadership positions in many litigations pending across the country involving defective or contaminated pharmaceutical and healthcare products, including Vioxx, Ephedra, Gadolinium contrast dye, contaminated Heparin and ReNu contact lense solution.
For more information on Burg Simpson, please go to www.burgsimpson.com.
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