Yaz and Yasmin have a history of FDA Warning Letters dating back more than six years. The primary warnings were for overstating the benefits of the drugs and minimizing the risks of use.
The FDA termed Yaz and Yasmin advertising spots as "misleading" and "particularly troubling" because the ads served to "undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience."
The FDA sent three letters to the makers of Yasmin and Yaz regarding the potential for hyperkalemia in highrisk patients and their failure to clarify that risk.
2003 FDA Yasmin Warning
The first FDA warning letter regarding Yaz and Yasmin focused on a 60-second TV commercial for Yasmin that made "superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives." The FDA went on to state that the Yasmin "TV ad raises significant public health and safety concerns."
2008 FDA Yaz Warning
In the 8-page FDA Warning Letter regarding Yaz dated October 3, 2008 two TV ads were cited as overstating the efficacy of the drug and minimizing the risks and side effects associated with using Yaz. Yaz related lawsuits allege that the warnings were inadequate in fully describing the potential side effects including heart attacks, strokes, gallbladder disease, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias and sudden death. The FDA sent three letters to the makers of Yasmin and Yaz regarding the potential for hyperkalemia in highrisk patients and their failure to clarify that risk.
2009 FDA Yaz Warning
The 2009 FDA Yaz Warning Letter regarded online advertising in sponsored search results, such as those found on Google, in which Bayer failed to disclose any risk associated with Yaz usage.. The FDA's letter stated "By omitting the most serious and frequently occurring risks associated with the drugs promoted in the links above, the sponsored links misleadingly suggest that Levitra, YAZ, and Mirena are safer than has been demonstrated. We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials."