Yaz for PMDD? FDA Warned Bayer about Exaggerating Symptom Relief

In the warning letter the FDA sent to Bayer in October of 2008, the agency faulted Bayer for misleading commercials the company had been airing for the birth control drug Yaz. In addition to inaccurately implying that Yaz could be used to treat all severities of acne as well as PMS, according to the FDA Bayer was also over-promising how well the drug treated the symptoms of PMDD.

In the warning letter, the FDA informed Bayer that its 60-second TV ads, “Not Gonna Take it” and “Balloons,” improperly implied that Yaz would relieve the symptoms of PMDD completely, and was inaccurate marketing. The misleading commercials showed visuals of balloons containing symtoms of PMDD floating away as the ad’s theme song “Good-Bye to You” played in the background.

The FDA stated that the visuals and audio improperly implied that women taking Yaz would “say good-bye” to or be completely relieved of the symptoms of PMDD. This misleading information was contrary to the results of the primary clinical trial that served as the basis for approval of Yaz, according to the FDA.

Although the ads stopped airing due to the FDA actions, they were seen by a large number of women in the U.S. Attorneys representing women injured by Yaz and Yasmin have filed lawsuits against Bayer alleging that women who would not otherwise have taken Yaz due to the health risks were induced to take the drug by the misleading information that their symptoms of PMDD would stop completely.

You may have questions if you were one of the women who took Yaz after seeing one of these misleading commercials, and you had serious Yaz side-effects. If you’re looking for answers for yourself or someone you know, contact us to find out the latest information on the litigation filed against Bayer.

Source:

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

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