FDA to drop black box warnings from menopause hormone therapies

By Christy Santhosh and Ahmed Aboulenein

Summary:

– FDA removes black box warnings on menopause hormone therapies.

– Two new treatments approved, including generic Premarin .

– Move expands patient access and eases safety fears.

WASHINGTON — The U.S. Food and Drug Administration said on Monday it would remove the strictest “ black box “ warnings from hormone therapies us ed to treat menopa us e symptoms, a move that may boost access to treatments long shunned by patients and doctors over safety fears.

FDA Commissioner Marty Makary said the decision follows an extensive review of scientific literature, input from an expert panel in July, and a public comment period.

“After 23 years of dogma, the FDA today is announcing that we are going to stop t