FDA Cites Bayer For Misleading Yaz Commercials
Submitted by Carina Rose on Thu, 10/09/2008 - 10:22
The U.S. Food and Drug Administration have cited two television commercials by Bayer Corp for Yaz birth control pills for giving a misleading impression of their benefits and downplaying the drugs risks. The F.D.A. has said that the ads incorrectly imply that the pills are approved for relieving premenstrual symptoms (PMS).
Rose Talarico, spokeswoman for Bayer Corp. said one ad’s campaign ended in 2007 and the other one would no longer be broadcasted. The commercial that has ended showed women singing “We’re not gonna take it” while kicking and punching balloons with “irritability,” “moodiness” and “bloating” written on them, symptoms commonly associated with PMS.
The F.D.A. says that Yaz is approved to treat a more serious condition called premenstrual dysphoric disorder, known to cause anxiety, tension, persistent anger and other symptoms and no evidence that Yaz eliminates PMS symptoms as the ads describe. "The TV ads misleadingly suggest that Yaz is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD," the FDA letter said.
Both the ads also "suggest that Yaz is approved for acne of all severities when this is not the case," the agency said it is only approved to treat moderate acne.
Another objection by the F.D.A. was the fast-moving images and background music that might be distracting to viewers while information about potential side effects, some 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 letter was posted on the FDA Website and Bayer has until October 20, 2008 to respond in writing.
