FDA Requires Bayer to Revise Marketing to Reflect New Yaz Warnings

The FDA is requiring Bayer Healthcare to update it’s marketing and advertisements for Yaz and Yasmin birth control pills to reflect new information about the risk of blood clots from Yaz and Yasmin that was recently added to the warning label. 

In an FDA letter to Bayer (PDF) approving new information the drug maker added about the relative risk of blood clots in women using Yasmin or Yaz compared to those using oral contraceptives that contain older progestins, the agency told Bayer that they must also promptly revise all promotional materials. The FDA indicates that the revisions must include “prominent disclosure of the important new safety information.”

Yaz and Yasmin are two similar birth control pills that are both manufactured by Bayer, containing drospirenone, a new “fourth” generation progestin. The drug maker faces a number of Yaz lawsuits and Yasmin lawsuits that allege the drug maker failed to adequately warn about the side effects of drospirenone, which could result in elevated potassium levels and lead to a condition known as hyperkalemia. In complaints, the newer type of progestin used in the birth control pills has been cited as the likely cause of an increased risk of blood clots and other serious side effects of Yaz and Yasmin.

A similar update to the Yasmin and Yaz warning label was made in Europe last month, to add information from studies that suggest the pills may carry a higher risk of blood clots than some other types of oral birth control that contain different type of progestin.

How Bayer advertises Yaz has been under close scrutiny by FDA since the company was cited for running deceptive ads that made unsubstantiated claims while drowning out information about the potential side effects with loud music. Early last year, Bayer was forced to run a $20 million corrective advertising campaign and is now required to submit any future Yaz advertisements to the FDA for approval before they are aired.