As part of a settlement with 27 states, Bayer will be changing the way in which it advertises Yaz, one of its birth control medications, reports BizJournal. This is in addition to a settlement in 2007 with Bayer that responded to cholesterol medication Baycol, said BizJournal. Baycol was pulled from the American market over safety concerns in 2001.
Late last year, the U.S. Food and Drug Administration (FDA) sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing that Yaz could help relieve symptoms associated with pre-menstrual Syndrome (PMS) and could also help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues, said BizJournal, which noted that Yaz is FDA-approved for some acne types only.
Federal regulators cited the Bayer Corporation for running the two misleading television commercials that touted certain treatments for which it is not approved and for minimizing Yaz’s risks. In its October 2008 letter to Bayer, the FDA wrote that Bayer’s television ads implied that Yaz was approved to treat the symptoms of PMS, with one commercial featuring women singing “We’re not gonna take it” and kicking, punching, and pushing balloons imprinted with words such as “irritability,” “moodiness,” and “bloating,” symptoms typically linked to PMS. Another ad features a song “Good Bye to You” with women releasing balloons labeled with the same symptoms, leading consumers to believe that Yaz will relieve, or release, the PMS symptoms listed on the balloons.
The FDA approved Yaz for the treatment of PDD—premenstrual dysphoric disorder—a more serious condition than PMS that causes anxiety, tension, and persistent anger, to name a few. The FDA letter said no evidence proves that Yaz can eliminate the PMS symptoms it touts it can treat in its advertisements.
Also, the FDA said both ads could leave consumers with the impression that Yaz can treat all types of acne, which is also not true; Yaz is approved to treat moderate acne. Additionally, the FDA cited that the ads used images and high image speed that could prove distracting to consumers while the side effect portion of the ad was running. For instance, information on potentially fatal blood clots was given while fast moving film images were flashed across the screen. “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.
As a result of the settlement, Bayer has been mandated to implement a $20 million dollar advertising campaign to “remedy” the misinformation it promoted. Bayer must also submit all subsequent television advertisements to the FDA for pre-approval; comply with the FDA on TV and print advertisement suggestions; and “clearly and conspicuously” disclose for what the FDA has approved when discussing—in its print ads—those symptoms Yaz can treat, said BizJournal.