Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer’s predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected. The FDA warned Bayer again in 2008, and again in 2009. Among Bayer’s more serious violations, according to the FDA, was that the commercials minimized the risks associated with Yaz while at the same time overstating its benefits — especially for conditions such as premenstrual syndrome for which the drug was never approved. According to the FDA:
These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.