FDA Advisory Committee Calls for Blood Clot Warnings on Yaz Contraceptive Labels

On December 9, 2011, an FDA panel of health experts voted 21 to 5 to recommend that label warnings be updated to include the potential risk for deep vein thrombosis in women who use Yaz, Yasmin and other combined oral contraceptives which contain the synthetic hormone drospirenone.

Yaz and Yasmin are fourth generation combined oral contraceptives (COC) containing the hormones drospirenone and ethinyl estradiol.  Both oral contraceptives are manufactured by Bayer HealthCare Pharmaceuticals, Inc. Drospirenone, a man-made progestin, is known to raise serum potassium levels in women, which may potentially lead to heart arrhythmias, deep vein thrombosis, strokes and death.

According to the British Medical Journal, women who use “oral contraceptives containing drospirenone face a two-to-threefold higher risk” for developing blood clots than women who use second generation birth control pills containing levonorgestrel.

Currently, more than 10,000 wrongful death and personal injury lawsuits are pending in state and federal courts against Bayer HealthCare Pharmaceuticals, Inc.  Plaintiffs allege injuries from Bayer’s combined oral contraceptives Yaz and Yasmin, ranging from gall bladder complications to pulmonary embolism and serious or fatal cardiovascular events.

Yaz was approved by the FDA in 2006, and given additional approval in 2007 to treat for moderate acne symptoms and Premenstrual Dysphoric Disorder (PMDD). The contraceptive was aggressively marketed by Bayer and soon became the most popular birth control pill in the United States. In 2008, Bayer reported combined earnings of $1.8 billion worldwide for Yaz and its predecessor pill, Yasmin.

In the fall of 2008, the FDA issued a warning letter to Bayer, saying that their television ads minimized the risks associated with the use of the drug, failed to distinguish between PMS and PMDD, and did not adequately communicate the fact that Yaz is not approved for the treatment of PMS.

Due to the crackdown by the FDA, Bayer HealthCare Pharmaceuticals revised the Yaz television ads and aired the new commercials in 27 states during January to July 2009.

The FDA recently examined data on 835,826 women who took the combined hormonal contraceptives containing drospirenone, including Yaz and Yasmin, and found that women who took the pills were 74% more at risk for developing blood clots than women on standard low-dose estrogen contraceptives.

Ironically, just one week before the December 9th Advisory Committee meeting called for more stringent safety labels on birth control products containing drospirinone, the FDA granted approval to Watson Laboratories, Inc.,  to market a generic version of Yaz. The new pill, containing drospirenone, is called Vestura.

If you or a loved one has been injured or disabled by a contraceptive containing drospirenone, such as Yaz, Yasmin, Ocella, Gianvi, Zarah, Loryna, Syeda, Safyral, Beyaz and Vestura, call the Wininger Law Firm today to speak to a product liability lawyer about seeking compensation for your injuries.