FDA Approves Labeling Changes to Menopausal Hormone Therapy Products

The FDA has approved the first wave of labeling changes for six menopausal hormone replacement therapy (HRT) products, removing boxed warnings about cardiovascular disease, breast cancer, and probable dementia.

This action follows FDA’s November 2025 assessment of the current relevant literature, including a reanalysis of data from younger cohorts of patients who initiated HRT within ten years of the onset of menopause, and its subsequent request for manufacturers to submit revised labels.

The newly updated products span systemic estrogen‑alone, systemic combination, progestogen‑alone, and topical vaginal estrogen therapies; drug labels can be viewed here. Randomized studies show that initiating HRT within 10 years of menopause onset, typically before age 60, can reduce all‑cause mortality and fracture risk. FDA stated that the changes are intended to provide women and clinicians with clearer, science‑based information to guide individualized decision‑making about menopause symptom management.

At Oasis Wellness & Recovery, we offer bioidentical HRT for women, including estradiol, progesterone, and testosterone. You can read the FDA release here and find out more about HRT for women on our website.

Call 352-325-5755 now to get your hormone levels checked and to schedule a consultation with Dr. Milbrandt.