FDA challenges Bayer’s TV commercial claims about Yaz

NEW YORK The Food and Drug Administration told Bayer in a letter Tuesday that two of the company’s TV commercials for its premenstrual dysphoric disorder drug Yaz are misleading.

The FDA said one commercial suggests the drug is approved for treating post-menopausal syndrome by saying it treats irritability, moodiness and bloating—symptoms common to PMDD and PMS. That commercial, which featured women hitting balloons while singing “We’re not gonna take it,” has been pulled.

The second commercial had the song “Good-Bye to You” and women releasing balloons with symptoms written on them. The FDA said evidence has not demonstrated that Yaz eliminates symptoms, even though the commercial suggests that it does.

Yaz (drospirenone and ethinyl estradiol) had global sales of $1.42 billion in 2007, according to Bayer financial data.