FDA Warns Bayer about Advertising Yaz for PMS

The birth control pill Yaz was approved in 2006 by the FDA for the treatment of premenstrual dysmorphic disorder (PMDD) in women who were also seeking birth control. In 2008 Bayer began airing the 60-second TV ads “Not Gonna Take it” and “Balloons”  to promote the new drug.

After numerous complaints from women injured by taking Yaz, the FDA sent Bayer a warning letter stating that Bayer’s ads improperly implied that Yaz was approved for the treatment of premenstrual syndrome (PMS), and was inaccurate marketing. The FDA took issue with the fact that the misleading commercials failed to adequately convey that Yaz was only appropriate for women who experienced the symptoms of PMDD, not the less severe syndrome PMS.

Misleading Yaz Commercials

The misleading commercials contained a list of symptoms such as anger, irritability, depressed mood, anxiety, bloating, change in appetite, headaches, and muscle aches, and the audio stated that “Yaz is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life.” The FDA stated that this claim failed to distinguish between PMS and PMDD, making the ads misleading.

FDA Confirms Yaz Not Approved to Treat PMS

The FDA noted that the statement in the ads’ text that “Yaz treats PMDD” along with small print that “PMDD is a mood disorder related to the menstrual cycle” was not sufficient to communicate that Yaz was not approved for the treatment of PMS, or to overcome the implied message created by the visuals and images in the ads that Yaz would be an appropriate treatment for any woman who experienced the symptoms listed in the ads.

The FDA also noted that the statement in the ads that “Yaz is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life” failed to communicate that Yaz is not approved for the treatment of PMS and failed to distinguish between PMS and PMDD.

Many women who began taking Yaz after seeing these misleading commercials suffered severe injury or death. Many of these women would not have started taking Yaz if the ads had properly informed them of the conditions Yaz was approved to treat, and of the risks involved in taking Yaz.

Due to the FDA actions, Bayer was forced to pull these ads and air a $20 million corrective advertising campaign to tell consumers the original ads were not clear.

Have you ever taken Yaz because you thought it would treat your PMS? Did your health suffer as a result?

Source:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

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