Commissioner Dr. Marty Makary says benefits have been underappreciated

Washington, D.C. – On Monday, the Food and Drug Administration announced its intention to eliminate the black‑box warnings that currently accompany many hormone‑replacement drugs prescribed for menopause.

Dr. Marty Makary, the agency’s commissioner, emphasized that “the benefits of hormone replacement have been consistently underappreciated,” citing recent studies that link the therapy to reduced hot‑flashes, improved bone density, and lower risk of certain cardiovascular events.

Nevertheless, the proposal has met with sharp criticism. Several experts and consumer‑advocacy groups argue that the evidence is “insufficient” to justify removing such a prominent safety alert, urging the FDA to conduct further long‑term research.

The agency has pledged to review additional data over the coming months before making a final decision.