Yaz Side Effects: FDA Warning Letters
-InjuryBoard
11/17/2009 - The Food and Drug Administration (FDA) has sent several warning letters to Bayer HealthCare Pharmaceuticals, Inc. for what the FDA termed “misleading” advertising spots it found “particularly troubling” because they 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.”
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 high-risk patients and their failure to clarify that risk.
2003 Yaz/Yasmin FDA Warning Letter
2008 Yaz/Yasmin FDA Warning Letter
2009 Yaz/Yasmin FDA Warning Letter
Yaz and Yasmin have been very popular among young women due to Bayer's "particularly troubling" advertising targeting young women and unconfirmed "benefits" of these birth control pills.
However, these drugs -- Yaz, Yasmin and Ocella -- have been linked to potentially deadly side effects, including heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT) and gallbladder trouble.
These serious side effects are caused by a key chemical found in Yas, Yasmin and Ocella -- Drosperinone.
