November 10, 2025
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FDA drops boxed warnings on menopause hormones

The FDA on Nov. 10 removed the boxed warning from more than 20 estrogen and progestin products used to treat menopause symptoms, citing evidence that risks are low when therapy starts before age 60 or within 10 years of menopause. The agency published revised prescribing information and a JAMA commentary by Commissioner Marty Makary, while noting ongoing debate and limiting use in women with complicating risks; HHS highlighted a shift toward more nuanced, evidence‑based risk communication.

Health Government/Regulatory

📌 Key Facts

  • Action: FDA removed the boxed warning from hormone therapy drugs for menopause (pills, patches, creams).
  • Date: Announced November 10, 2025, with supporting JAMA commentary by FDA officials.
  • Rationale: Data suggest limited risks when started before age 60 or within 10 years of menopause; labels updated to align with current guidance.