In Brief: Label Changes for Menopausal Hormone Therapy Products
Abstract
The FDA has requested the removal of some boxed warnings from the labels of vaginal and systemic menopausal hormone therapy (MHT) products. The warnings were initially added in 2003 based on the results of two placebo-controlled Women's Health Initiative (WHI) trials evaluating the use of systemic hormones for primary prevention of coronary heart disease (CHD) in postmenopausal women 50-79 years old.
Fields of Study & Subjects
Menopause: Health Impacts and Treatments
Pharmacovigilance and Adverse Drug Reactions
Reproductive Health and Contraception
Publication details
- Journal / source
- The medical letter on drugs and therapeutics/The medical letter
- Volume
- 68
- Issue
- 1748
- Pages
- 30–31
- Publication date
- 1 January 2026
- Language
- EN