FDA 'Not Gonna Take It,' Bursts Yaz's 'Balloons'

摘要

Two direct-to-consumer (DTC) television advertisements for Bayer's contraceptive Yaz are misleading because they broaden its indication, overstate its efficacy and minimize serious risks, the FDA says. The 60-second spots, "Not Gonna Take It" and "Balloons," should be withdrawn immediately, the Division of Drug Marketing, Advertising and Communications (DDMAC) says in a warning letter to the company. The ads misbrand the drag, the agency says. "These violations ... encourage use of Yaz in circumstances other than those in which the drag has been approved," the letter states.