Black Box Warning Facts: Why is the FDA Removing the Warning Label from Hormone Therapy Drugs

In a historic decision, the US Food and Drug Administration (FDA) has announced it will remove the 'black box' warnings from most hormone replacement therapy (HRT) medications used to treat menopause. The move, supported by new research and expert consensus, marks a turning point for women's health after more than two decades of fear, stigma, and under-treatment linked to hormone therapy.

The change follows a comprehensive review of scientific data showing that hormone therapy is far safer than previously believed when prescribed appropriately — particularly for women under 60 or within 10 years of menopause onset.

Why the Warnings Were There in the First Place

'Black box' warnings — the most severe caution label issued by the FDA — were added to HRT drugs in 2003 following the Women's Health Initiative (WHI) trials. Those studies suggested an increased risk of breast cancer, stroke, and heart disease among women using hormone therapy. However, experts have long criticised those findings for being misapplied to the wrong age group, as most participants were women in their 60s and 70s, well past typical menopause onset.

Subsequent research has shown that younger women face significantly lower risks when HRT is used early and appropriately.

What Has Changed and Why It Matters

The FDA's latest review concluded that the old warnings were outdated and misleading, particularly for products that contain modern formulations of oestrogen and progesterone. As a result, the agency is removing risk statements related to cardiovascular disease, breast cancer, and dementia from packaging labels.

The updated guidance applies to most forms of HRT — including pills, patches, gels, and creams — while retaining limited warnings for endometrial cancer in oestrogen-only therapies. The FDA will also recommend that women start hormone therapy before age 60 or within 10 years of menopause onset for maximum benefit.

According to the FDA's internal data, HRT can reduce the risk of bone fractures by up to 60%, cut heart disease risk by 50%, and lower the likelihood of Alzheimer's by 35% in some women. 'Every single part of a woman's body depends on oestrogen to operate at its best — including the brain, bones, heart, and muscles,' said Dr Alicia Jackson, Director of the Advanced Research Projects Agency for Health.

For many women, this decision offers long-awaited validation.

'We are going to stop the fear machine steering women away from this life-changing, even lifesaving, treatment,' said FDA Commissioner Marty Makary, who co-authored an editorial in JAMA announcing the policy shift.

A New Era for Menopause Treatment

Clinicians have hailed the FDA's move as a victory for women's autonomy and health literacy. Dr MargEva Cole, an obstetrician-gynaecologist at Duke University School of Medicine, said that the black box had scared off many patients who could have benefited from treatment.

'Our big concern about the black box warning is that a lot of women are excited about walking out of the office and then go home and read the black box — and then never start it,' she explained.

While experts caution that HRT is not suitable for everyone, especially women with a history of hormone-sensitive cancers, they agree that the benefits far outweigh the risks for the majority. Dr Tiffany Troso-Sandoval, a New York oncologist, noted that localised oestrogen treatments — such as vaginal creams — are now considered safe even for many cancer survivors, with careful medical guidance.

The FDA's decision also coincides with the approval of two new drugs: a generic version of Premarin, which will make treatment more affordable, and a non-hormonal medication for moderate to severe hot flashes.

What Women Should Know Going Forward

The FDA's reversal doesn't mean that hormone therapy is without risk — but it does signal a broader commitment to accurate, nuanced communication about women's health. Doctors are encouraging patients to have individualised consultations, weighing benefits such as mood regulation, bone health, and cardiovascular protection against their personal medical history.

'Women and their physicians should make decisions based on data, not fear,' said Dr Makary. 'This is about restoring trust in science — and in women's ability to make informed choices about their bodies.'

The removal of these warnings represents a long-overdue correction in the way women's health has been framed and managed.

For millions entering or enduring menopause, it opens the door to more confident, evidence-based conversations about treatment and well-being.