Dangers of Yasmin, Yaz and Ocella
National Yasmin, Yaz and Ocella Litigation Attorneys
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 Food & Drug Administration (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, the 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, the FDA is aware of the added clinical risks associated with drospirenone . . ." Further, the 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, the FDA issued a Warning Letter to Bayer, for another false and misleading advertisement concerning Yaz. The 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.) The FDA reiterated that the marketing was misleading because it promoted YAZ for medical conditions beyond the limits of the FDA approval. But also, the 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."
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 lens solution.
Please contact the experienced Yasmin attorneys at Burg Simpson Eldredge Hersh & Jardine, P.C. if you or a loved one has been sickened by Yasmin or Yaz.
This website is sponsored by Burg Simpson Eldredge Hersh & Jardine, PC.