Federal regulators have cited the maker of the Yaz birth control pill for running two misleading commercials that play down the risks of the drug. In response, Bayer Corp. said it would stop running one of the two ads currently in use. The other Yaz campaign cited by the Food & Drug Administration (FDA) ended in 2007.
In a letter date October 3, FDA said that the Bayer TV ads implied that Yaz was approved to treat the symptoms of premenstrual syndrome (PMS). In one commercial - which no longer runs - women are singing “We’re not gonna take it” and kicking, punching and pushing balloons with words such as “irritability,” “moodiness” and “bloating.” Those symptoms are commonly associated with PMS.
A second ad features a song “Good Bye to You” with women releasing balloons labeled with the same symptoms. The commercial suggests “women are saying ‘goodbye’ to their symptoms and are now symptom-free.
According to the FDA, Yaz is only approved for premenstrual dysphoric disorder, a more serious condition that causes anxiety, tension, persistent anger and other symptoms. In its letter, the FDA said there is no evidence that Yaz eliminates the PMS symptoms described by the ads.
The FDA also said that both ads left the impression that Yaz is approved as a treatment for acne of all severities when this is not the case. Yaz is only approved to treat moderate acne.
The FDA also said that the ads contained fast-moving images and background music, that might be distracting to viewers. These elements were aired while information about potential Yaz side effects - including potentially life-threatening blood clots - was described.
“These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening,” the agency said.
The FDA has given Bayer until October 20, 2008 to submit a written response to its letter.
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