Abramson, Brown & Dugan Attorneys

The FDA has told Bayer Healthcare to revise its marketing materials for Yaz and Yasmin to reflect the new safety labels which emphasizes the prominent disclosure of safety information.  Bayer has previously been criticized by the FDA for incomplete safety information in its marketing materials.

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."

Unlike other contraceptive medicines, Yas and Yasmin are made with a type of progestin called drospirenone which has been known to elevate the body's potassium levels which, in turn, can develop into hyperkalemia.  Hyperkalemia can lead to serious cardiac and other health issues. 

Presently, there are approximately 1,100 Yaz and Yasmin lawsuits which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.