History of Yaz

Yaz was originally approved by the U.S. Food and Drug Administration (FDA) in 2006, as a once-daily birth control pill, and that same year, Yaz’s approval was expanded to include treatment of the physical and emotional symptoms of premenstrual dysphoric disorder (PMDD), a more severe form of PMS that can interfere with a woman’s daily activities. In January 2007, Yaz was additionally indicated for the treatment of moderate acne in women who also want to prevent unwanted pregnancy.

Since 2003, the FDA has issued several warnings to Bayer in regard to its marketing practices for Yaz and Yasmin birth control, forcing the company to correct television and internet advertisements that overstated the benefits of its oral contraceptives, while downplaying their risks. In December 2008, an FDA panel voted in favor of adding a black box warning on the Yaz and Yasmin drug labels to highlight the increased risk of serious cardiovascular events associated with the use of the oral contraceptives among women who smoke.

In October 2011, a study published in the British Medical Journal found that women taking Yaz or Yasmin experienced a two-times increased risk of blood clots, compared to women who used older contraceptives, and the Institute for Safe Medication Practices (ISMP) reported that Yaz and Yasmin ranked second highest in 2011, for the number of adverse events reported to the FDA in connection with the birth control pills.