Bayer Agrees To Stop Running Ads For Oral Contraceptive YAZ That FDA Says Are 'Misleading'

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals
Article Date: 10 Oct 2008 - 8:00 PDT

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Earlier this week, the pharmaceutical company Bayer agreed to stop airing commercials for the oral contraceptive YAZ in response to an Oct. 3 warning letter from FDA telling the company that the advertisements overstate the benefits of the drug. According to the FDA letter, the commercials "broaden the drug's indication, overstate the efficacy of YAZ and minimize serious risks associated with the use of the drug." YAZ is approved for symptoms related to treatment of a more severe form of PMS -- called premenstrual dysphoric disorder, or PMDD -- which can be anxiety, tension and persistent anger -- but the drug is not approved for the treatment of the less serious premenstrual syndrome, or PMS. FDA also objects to the suggestion in both ads that YAZ is approved for acne of all severities -- when in fact YAZ is indicated for the treatment of "moderate acne."

One of the ads features women singing, "We're not gonna take it" and hitting balloons that have words such as "bloating," "irritability," and "moodiness" on them. According to the FDA letter, the other ad features women releasing the balloons with the words on them and suggesting that "women are saying 'goodbye' to their symptoms and are now symptom-free," although the elimination of symptoms associated with PMS "has not been demonstrated by substantial evidence or substantial clinical experience." Bayer stopped running one of the ads in 2007 and will stop running the other ad, company spokesperson Rose Talarico said.

FDA also said that the "complex presentations" used in the commercials, including fast-moving images and background music, which could make it difficult for viewers to comprehend the important risks of taking YAZ. "This is particularly troubling as some of the risks being conveyed are serious, even life-threatening," the FDA letter says (Heavey/Richwine, Reuters, 10/8). FDA has requested that Bayer respond to its letter by Oct. 20 and explain how the company will complete corrective measures to the audience that saw the misleading ads, the Dow Jones/Morning Star reports (Favole, Dow Jones/Morning Star, 10/8).

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