FDA Admonishes Bayer for Misleading Yaz Ads; Patients Harmed by Yaz Should Seek Legal Counsel
Bayer’s 2008 marketing campaign for its prescription birth control pill Yaz was misleading to the general public, according to the U.S. Food and Drug Administration (FDA). Bayer Healthcare Pharmaceuticals is one of the most prominent pharmaceutical companies worldwide.
In October 2008, the FDA issued a warning letter to Bayer informing the drug manufacturer that the ads violated U.S. law and requiring the company to immediately remove the TV ads from the air waves. Bayer was further instructed to submit a plan to the FDA to ensure that future marketing campaigns would not violate the law.
Which Bayer ads were at Issue in the FDA’s October 2008 Warning Letter?
Two sixty second TV commercials were the subject of the FDA’s October 2008 Warning Letter to Bayer. The ads were titled “Balloons” and “Not Gonna Take It.” Both ads communicate to viewers that Yaz is different from and superior to other kinds of birth control pills. The ads indicate that Yaz can do more than provide birth control and have women hitting words off the screen that are commonly associated with premenstrual syndrome (PMS).
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How did the ads overstate the drug Yaz’s effectiveness?
The ads imply that women can be completely symptom free of symptoms commonly associated with PMS, premenstrual dysphoric disorder (PMDD) and, acne. This is not supported by clinical facts. There is no evidence that Yaz use will result in the reduction of PMS symptoms or the elimination of PMDD symptoms. Similarly, the ads show women with clear skin and while Yaz is effective in reducing lesions associated with moderate acne it is not proven to provide women with clear skin.
How did the ads broaden the uses of Yaz?
The ads broaden the uses of Yaz in several ways. First, the ads implied that Yaz was approved to treat acnes of all severities which is incorrect. It is not approved for treating mild acne. Second, the ads imply that Yaz can teat PMS, a use for which it is not approved.
How did the ads minimize the serious risks associated with Yaz?
In addition to overstating the uses and efficacy of Yaz, the ads minimize the serious risks associated with the drug. The ads were found to be distracting during the important risk disclosures statement. The FDA found that the visuals used, the scene changes and the background music distracted from the seriousness of the message being conveyed and that they were particularly concerned since the side effects could be life threatening.
Do You Have a YAZ Birth Control Lawsuit? »
Over the years, the marketing of Yasmin has been similar to the marketing of Yaz. In fact, in 2003 the FDA issued a similar letter to Berlex, the previous manufacturer of the drug, about the misleading and untruthful marketing of Yasmin.
Patients who have suffered serious medical side effects from Yaz or Yasmin may have causes of action against Bayer, whether or not they relied on the misleading ads. If you have any questions about whether you can recover damages for your injuries, please contact an experienced pharmaceutical litigation attorney for a free case evaluation.
