Yasmin®, Yaz®, and Ocella are all birth control pills manufactured by Bayer Healthcare. Ocella is a generic form of Yasmin®, marketed and distributed by Teva Pharmaceuticals. Yasmin® was approved by the FDA in 2001, Yaz® in 2006, and Ocella in 2008.
The Yaz group of drugs contains a compound created by Bayer called drospirenone, a synthetic progestogen that is believed to elevate the levels of potassium in the body. Side effects of drospirenone and/or elevated potassium include heart attack, stroke, blood clots, damaged kidneys, damaged gallbladder, abnormal heartbeat, and even death.
The Yaz drugs are also marketed to reduce premenstrual water retention and bloating. Drospirenone acts as a diuretic and can lead to dehydration, which in turn can lead to blood clots and kidney damage.
The FDA has warned the manufacturers of Yaz® and Yasmin® at least four times for improper marketing and manufacturing techniques.
In July of 2003, the FDA notified Bayer’s predecessor, Berlex Laboratories, that their commercials for Yasmin® were misleading and in violation of federal law. First, the commercials implied that Yaz® was more effective than other contraceptives, with no proof for this assertion. Second, the commercials failed to warn of the dangers from elevated potassium levels.
In October of 2008, the FDA again issued a warning about deceptive advertising, this time for Yaz®. The FDA determined that Bayer again overstated the effectiveness of the drug and minimized the serious side effects. Yaz® is also used to treat premenstrual dysphoric disorder—premenstrual depression—but the FDA chastised Bayer for using the abbreviation “PMDD” because it could lead women to believe that the drug could be used to treat PMS—not a valid indication.
In March of 2009, Yaz® was the subject of a third round of FDA complaint. The FDA determined that internet marketing failed to provide information on the risks of the drug, and also improperly implied that Yaz® could be used for treating acne.
Finally, on August 5, 2009, the FDA issued yet another complaint letter to Bayer, in which it stated that Bayer had failed to address safety concerns found during a March 2009 inspection of a manufacturing facility in Germany. In March, the FDA discovered significant deviations from quality control standards with respect to the manufacture of Yaz® drug, including failure to weed out impurities, failure to maintain clean equipment, and failure to adequately test final products. The FDA was especially concerned that some of Bayer’s internal directives with respect to handling manufacturing specifications might have been in place in other manufacturing and testing facilities.
Bayer had been given an opportunity to remedy these deviations, but months later has failed to do so to the FDA’s satisfaction. Meanwhile, hundreds (if not thousands) of women have suffered avoidable injuries, even death, as a result of Bayer’s misleading advertising practices and potentially defective manufacturing processes.
If you or a loved one has suffered any side effects after using Yasmin®, Yaz® or Ocella, contact the attorneys at Lopez McHugh LLP for a free consultation.