When Removals Of Warnings Are Political Rather Than Scientific - And ACOG Applauds It

The FDA’s removal of boxed warnings from menopausal hormone therapy, and ACOG’s celebration of it, reveal a troubling disregard for patient autonomy and coherent risk communication.

Definition of the issue: A boxed warning is the strongest safety communication the FDA issues. It exists to alert patients and clinicians to clinically significant risks that require explicit discussion. The FDA recently removed this warning from many menopausal hormone therapy products. The American College of ObGyns (ACOG) and other professional orga…