Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms, and as an effective treatment for moderate acne.

However, the FDA says the original television commercial implied Yaz could also treat Premenstrual Syndrome (PMS) and that it would keep a woman’s skin clear and/or treat more severe acne. Worse than this, the FDA says the commercials used distracting visuals, numerous scene changes, and competing background music that interfered with the audio presentation of the serious risks associated with the product.

“This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the FDA letter states. The overall effect of the distractions adds up to “undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

As a result of the FDA’s findings, the attorneys general of 27 states joined the federal agency in cracking down on misleading consumer advertising, and Bayer was required to create new ads to more clearly communicate the benefits and risks of its product, at a cost of $20 million.

But don’t feel too sorry for Bayer yet. Yaz is the best-selling oral contraceptive product in the United States, with sales in 2008 topping $600 million.

In the new campaign, a young woman seriously addresses the camera, while reminding viewers that they may have heard of Yaz on previous commercials, but that she’s here because “the FDA wants us to correct a few points in those ads.”

Source: New York Times

SOURCE: Yaz Lawsuit › Bayer creates new ad campaign for Yaz after FDA crackdown