FDA Warning Letters
The FDA sent a Warning Letter to Bayer HealthCare Pharmaceuticals, Inc. regarding what it termed as "misleading" advertising spots that it found "particularly troubling" becaused the 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.
Attention! Yaz, Yasmin and Ocella Have Been Linked to Heart Attack, Stroke, and Life-Threatening Blood Clots
Yaz, Yasmin and Ocella are combination birth control pills that contain a chemical progestin called drospirenone. Drospirenone has been associated with a number of very dangerous and potentially fatal side effects.
Drospirenone is a diuretic with antimineralocortoid properties that can cause hyperkalemia and lead to thrombosis. Drospirenone can make the potassium levels in your blood go to dangerous levels and cause potentially life-threatening blood clots, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT), gallbladder disease, liver or kidney failure, sudden cardiac death, and a number of other serious medical problems.
The drospirenone contained in Yaz, Yasmin and Ocella is not used in any other combination oral contraceptive on the market in the United States.
2003
FDA Yasmin Warning Letter
2008
FDA Yasmin Warning Letter
2009
FDA Yasmin Warning Letter
