Yaz, Yasmin Label Updated to Included Information on Blood Clots

New safety information regarding the risk of blood clots has been added to the labels of Yaz and Yasmin, Bayer Healthcare’s popular birth control pills. The label update comes as Bayer faces at least 1,100 lawsuits filed by women who claim to have been injured by either Yaz or Yasmin.

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. Adverse Events reported to the U.S. Food & Drug Administration (FDA) involving Yaz and Yasmin 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.

On Friday, Bayer issued a press release announcing the label update for Yaz and Yasmin. The release stated:

“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.”

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., Bayer said.

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. 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. Almost every Yaz lawsuit claimed Bayer’s birth control pills caused plaintiffs to suffer blood clots, heart attacks, stroke, gallbladder disease and other health problems.

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