The Food & Drug Administration (FDA) has told Bayer Healthcare to revise its marketing materials for Yaz and Yasmin. The FDA’s directive follows Bayer’s announcement last week that it was adding new safety information regarding the risk of blood clots the drugs’ label.
In its letter dated April 7 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.” The agency said revisions must include “prominent disclosure of the important new safety information.
Bayer was given seven days from the date of the letter to comply with the FDA directive.
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 as Yaz side effects. 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. Almost every Yaz lawsuit claims the drugs caused plaintiff to suffer blood clots, heart attacks, stroke, gallbladder disease and other health problems.