Hello Health Advocates
I am so excited to share this news , a significant international development that has positive implications for women’s health globally: the U.S. FDA has officially removed the long-standing black-box warnings from many FDA-approved hormone replacement therapy (HRT) products used for menopausal care.
This decision is a major victory for women’s health, recognising what clinicians and compounding pharmacies like ours have long observed—the safety and effectiveness of well-prescribed hormone therapy when used appropriately.
While this update comes from the United States, it reinforces what many Australian practitioners already apply in evidence-based care: HRT, particularly when initiated around the time of menopause, offers meaningful symptom relief and important long-term health benefits.
As an Australian pharmacy with more than 25 years of specialised experience in bio-identical hormone compounding, we have consistently championed access to personalised, physiologically aligned hormone options. The FDA’s action provides strong global validation for the work you do every day to support women through the menopausal transition.
Key highlights from the FDA announcement:
Black-box warnings related to cardiovascular disease, breast cancer, and dementia have been removed—a powerful acknowledgment of modern evidence and a reduction in fear-based barriers for patients.
The endometrial cancer warning remains only for systemic estrogen-alone therapy in women with a uterus.
Updated guidance encourages considering HRT within 10 years of menopause or before age 60, reflecting data on optimal therapeutic timing.
This international shift is expected to empower more women to explore hormone therapy confidently and without outdated stigma. It also aligns with the direction many Australian practitioners have already taken—prioritising individualised assessment, risk-balanced care, and evidence-supported treatment.
We’re here to support you with customised formulations, practitioner resources, and patient education tools to help you navigate this positive change. At Formulae, we provide a wide range of bio-identical hormone replacement therapies tailored to individual needs. Reach out to us to learn more about our BHRT protocols and how you can continue pioneering advancements in women’s health.
Cheers Lou xx
