Yasmin was first approved by the FDA in 2001. Yasmin contains 3 mg of drospirenone and a .03 mg dose of ethinyl estradiol. It is marketed and sold in the United States by Bayer Healthcare Pharmaceuticals.
Yaz was first approved by the FDA in 2006. It is also marketed and sold in the United States by Bayer. Yaz contains a 3 mg dose of drospirenone and a .02 mng dose of ethinyl estradiol.
Ocella was first approved by the FDA in 2008. Ocella contains 3 mg of drospirenone and a .03 mg dose of ethinyl estradiol. It is an oral contraceptive product sold by another manufacturer, and had estimated sales of $170 million in the United States in 2008.
Studies performed prior to FDA approval in 2001 indicated that drospirenone had certain effects that are different, and potentially more dangerous, than the effects noted with older progestins found in other birth control controceptives.
Yasmin’s new progestin, drospirenone, was intially marketed by stating, “Ask about Yasmin, and the difference a little chemistry can make.” In response to these marketing efforts, on July 10, 2003, the FDA objected to the characterization that drospirenone was a benefit compared to the progestins used in other combined oral contraceptives, and issued a warning letter to Defendants stating, “FDA is not aware of substantial evidence of substantial clinical experience demonstrating that Yasmin is superior to other COCs [combined oral contraceptives] or that the drospirenone in Yasmnin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone.”
In April of 2002, The British Medical Journal published a report reflecting that the Dutch College of General Practitioners had documented 40 cases of venous thrombosis among women taking Yasmin. In light of these findings, these researchers recommended that women use older, more established birth control pills instead of Yasmin.
Between the first quarter of 2004 and the third quarter of 2008, the FDA received reports of more than 50 teenage girls and young women whose deaths were attributed to their use of Yasmnin, Yaz, and/or Ocella. The deaths were caused by elevated potassium levels, cardiac arrhythmia. cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke.
Finally, two studies published in August of 2009 in The British Medical Journal confirmed a significantly increased risk of harm associated with use of Yasmin or Yaz over other types of birth control pills.