FDA to remove 'black box' safety label from hormone therapy for menopause

The US Food and Drug Administration (FDA) announced Monday, 10 November 2025, that hormone-based treatments for menopause symptoms will no longer carry a bold warning label about serious risks such as stroke, heart attack, and dementia.

The change affects more than 20 pills, patches, and creams containing hormones like estrogen and progestin, which are approved to relieve disruptive symptoms such as hot flashes and night sweats.

FDA officials cited recent research indicating that hormone therapy poses minimal risks when started before age 60 and within 10 years of menopause onset. “The current boxed warning is outdated and unnecessary,” said FDA Commissioner Marty Makary, who supports the change.

The original FDA warning, introduced 22 years ago, highlighted risks of blood clots, heart problems, and other health issues based on a landmark study from more than two decades ago.

Many doctors and pharmaceutical companies have argued that he label discouraged treatment and unnecessarily alarmed women who could benefit from therapy.

Women’s health experts praised the move to update the warning to reflect newer scientific evidence around menopausal hormone therapy, but said individualised discussions with health professionals of risks and benefits will still be needed.

"I know a lot of women who wouldn't go on it because of that narrative," says Primedia Digital Content Editor Barbara Friedman. "Maybe look into the new research and decide for yourself.

"New evidence shows that it's much safer and effective than previously thought, and it has a lot of good outcomes for women as they hit menopause and beyond. So, it's sort of destigmatising it.

I hink there was an overcorrection that needed to be made."

To listen to Friedman in conversation with Clarence Ford on CapeTalk's Views and News, click below: