Blood Clot Info Added to Yaz, Yasmin LabelsApr 12, 2010 | Parker Waichman LLP
Bayer Healthcare has updated the labels for Yaz and Yasmin to include new information about the contraceptives' blood clot risks. The new information is based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K.
In a press release issued Friday, Bayer said:
“The updated labels confirm that the body of evidence continues to support that the relative risk of developing venous thromboembolism (VTE) in YAZ and Yasmin users is comparable to that of other combination oral contraceptive preparations, including those containing levonorgestrel. The labels also state, unchanged, that there is a risk of VTE among all combination oral contraceptives (a class effect), and provides additional information and context about data specific to drospirenone containing oral contraceptives.”
Yaz and Yasmin are both made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Yasmin and Yaz side effects reported to the U.S. Food & Drug Administration (FDA) include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.
In the U.S., Yaz and Yasmin have been named in about 1,100 lawsuit, many of which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois. Almost every Yaz lawsuit claims the drugs caused plaintiff to suffer blood clots, heart attacks, stroke, gallbladder disease and other health problems.
Bayer also faces three putative consumer class actions claiming economic loss, one of them also claiming personal injuries, as well as two class actions in Canada.