Overview
- The agency said it will ask manufacturers to strip boxed warnings from more than 20 estrogen and progestin pills, patches, sprays and creams used to treat menopause symptoms.
- New guidance on labels recommends starting hormone therapy before age 60 or within 10 years of menopause onset, reflecting evidence that risks vary by age and formulation.
- Risk information will remain in prescribing inserts, and a boxed warning stays to indicate that women with a uterus should use progestin with estrogen to reduce endometrial cancer risk.
- Officials and clinicians expect the change to expand access and increase prescriptions, after years of declines following the 2002 Women’s Health Initiative findings.
- Critics question the review process, noting the FDA did not convene a formal independent advisory committee and instead relied on a panel that included experts with industry ties.