On 11th November 2025, the US Food and Drug Administration (FDA) has removed the “black box” warning from all hormone therapy products used to treat perimenopause and menopause.

This warning has been in place for more than 20 years and was introduced after early results from the Women’s Health Initiative in 2002 suggested that hormone therapy increased the risk of breast cancer, heart disease and stroke.

We now know that those early findings were misinterpreted and misreported. For the majority of women, hormone therapy is safe and when the right type is given at the right time, it can reduce the risk of heart disease, protect bone health, and significantly improve quality of life.

However, because of this long-standing black boxed warning, many women have been too afraid to take it, and we have a generation of doctors who were told it was dangerous and were never properly trained to prescribe it.

In Australia, the Therapeutic Goods Administration (TGA) uses the term “boxed warning” for its strongest type of safety warning, which appears in the Product Information (PI) and Consumer Medicine Information (CMI). These warnings can and should be reviewed or removed when evidence changes.

We are calling on the Australian Government and the TGA to follow the FDA’s lead and remove or revise the boxed warning on body-identical menopause hormone therapy products so that information reflects the best available evidence.

Health professionals and women deserve accurate, up-to-date information, not outdated warnings that continue to cause fear and confusion.

This is an opportunity to reset menopause care in Australia. The science is clear: when prescribed appropriately, body-identical hormone therapy is safe and can be life-changing. When clinicians are supported and women are informed, everyone benefits.

Please sign our petition and help ensure Australian policy catches up with the evidence.

About Healthy Hormones

Healthy Hormones is a GP-led initiative working to improve menopause care across Australia. We’re transforming the way hormonal health is understood and supported through better education, open conversation, and real connection.

Our free app gives clinicians access to real-time support and education, including our Essentials Menopause Course, which is the only comprehensive menopause training program available in Australia for doctors, nurses, pharmacists, and other health professionals.

Through the app, women and their families can also join our free online community, where they can learn about menopause, ask questions, and share their experiences in a trusted, evidence-based environment.

The Healthy Hormones app is free to download from the App Store and Google Play.