Overview
- The agency ended the requirement on Nov. 10 for a range of therapies used for menopausal and perimenopausal symptoms.
- An FDA-convened expert panel reviewed risks and benefits on July 17, paving the way for the label change.
- Clinicians say the update aligns labels with current data and may reduce stigma, encouraging appropriate prescribing and shared decision-making.
- Evidence and experts highlight that risks differ by route and timing, with transdermal or vaginal estrogen seen as lower clot and stroke risk than some oral forms, and benefits most favorable for women under 60 or within 10 years of menopause.
- Individualized assessment remains essential, including pairing estrogen with progesterone for women with a uterus to protect the endometrium, watching for early side effects such as bleeding, and addressing widespread gaps in menopause training among clinicians.