FDA issues warning letter over Yaz DTC ads

The FDA has issued a warning letter to Bayer for two commercials, "Not Gonna Take It" and "Balloons," for its birth control pill, Yaz. According to the FDA, the commercials overstate the efficacy of the pill, minimize its risks and broadens the pills indication by falsely suggesting that Yaz has been approved for treating pre-menstrual syndrome.

The Yaz label warns patients that the contraceptive has not been evaluated to treat premenstrual syndrome, but the FDA notes that this is not mentioned in the "Not Gonna Take It" commercial. Yaz is in fact approved for treating "moderate acne vulgarities," as well as premenstrual dysphoric disorder (PMDD)--a more severe condition that causes disruptive emotional and physical symptoms, including depression, anxiety, persistent anger, headaches and joint pain. But, according to the warning letter, not only does the commercial suggest  that Yaz's is able to treat acne of all severities, in touting the benefits of Yaz in treating such common symptoms as "irritability" and "moodiness," the commercial fails to distinguish between PMS and the more serious PMDD, leading viewers to believe that Yaz is effective at treating PMS.

The FDA also warns Bayer about a second commercial, "Balloons (video [1])," in which the song "Goodbye to You" plays in the background as women release balloons displaying their symptoms into the air. The agency says the ad misleads viewers to believe that Yaz can completely cure patients of their symptoms.

- check out the "Balloons [1]" commercial
- view the FDA warning letter [2] (.pdf)
- view the FDA story board [3] of "Not Gonna Take It" (.pdf)

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House, Senate hook up on DTC ads [5]
Drug sales and marketing update: September 2008 [6]
Pharma cuts 2008 ad budgets [7]