Federal regulators are requiring Bayer Healthcare to revise its marketing materials for Yaz and Yasmin to reflect new safety information that was recently added to the drugs’ labels. In a letter to Bayer dated April 7, the Food & Drug Administration (FDA) said revisions must include â€œprominent disclosure of the important new safety information.â€
As we reported earlier this week, Bayer announced last Friday that it was updating the “Warning” sections of the Yaz and Yasmin labels to include additional information about the risk of blood clots associated with the birth control pills. 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 its letter approving the label changes, the FDA said: “All promotional materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement, including any new safety information.”
Bayer was given seven days from the date of the letter to comply with the FDA directive.
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 bodyâ€™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 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.
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. The lawsuits claim Yaz and Yasmin caused plaintiffs to suffer blood clots, heart attacks, stroke, gallbladder disease and other Yaz side effects.