Life Sciences

FDA warns Bayer about YAZ ads

Pharma Compliance Alert, October 15, 2008

Two 60-second direct-to-consumer advertisements for Bayer’s birth control pill YAZ overstate the product’s effectiveness, according to an FDA warning letter.

The FDA said the ads also broaden the drug’s indication and minimize serious risks associated with the use of the drug.

Bayer’s “Not Gonna Take It” and “Balloons ads” do not use the full phrase “premenstrual dysphoric disorder” (PMDD) to differentiate between that condition and premenstrual syndrome (PMS). YAZ is not approved to treat PMS. In addition, the symptoms displayed in the ad are more common in women with PMS. The ads also claim YAZ is approved for acne of all severities even though it is not.

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