By Dr. Ali Aldibbiat — MD, PhD, FRCP (London & Edinburgh), FACE. Consultant Endocrinologist, Newcastle Vitality Clinic, Jumeirah, Dubai.
On 10 November 2025, the US Food and Drug Administration began removing the black box warning — the most serious warning a medicine can carry — from menopausal hormone therapy products. For twenty years that warning shaped how women and their doctors thought about HRT. Its removal has been reported as a vindication, a reversal, and in some places a green light.
It is none of those things exactly. Here is what actually changed, what did not, and what it means for a woman weighing this decision in Dubai.
What actually happened
The FDA removed boxed warnings covering cardiovascular disease, breast cancer and probable dementia from menopausal hormone therapy products. The decision followed an expert panel convened in July 2025 and a review of the accumulated literature.
One boxed warning remains: the endometrial cancer warning on systemic oestrogen-only products. That warning is there for a good reason, and it is the basis of a rule that has not changed at all — a woman with a uterus who takes systemic oestrogen must also take a progestogen to protect the lining of the womb.
The agency also approved a generic version of conjugated oestrogens and a non-hormonal treatment for hot flushes in the same announcement.
The single most important thing to understand: a label change is a regulatory decision about how risk is communicated. It is not new evidence. No trial reported in November 2025 that made HRT safer than it was in October 2025. What changed was the official assessment of how the existing evidence had been presented — and, in the FDA’s view, misrepresented — for two decades.
Why the original warning was misleading: the WHI story, told properly
To understand the change you have to understand where the warning came from.
In 2002, the Women’s Health Initiative — a large randomised trial — was stopped early and reported an increased risk of breast cancer and cardiovascular events in women taking combined hormone therapy. The finding was announced dramatically, reported globally, and within a few years HRT prescribing had collapsed across the Western world. A generation of women went through menopause untreated, and a generation of doctors trained to be afraid of these medicines.
The problem was not that the trial was wrong. It was that its findings were applied to women it never studied.
The participants averaged about 63 years of age. For most women that is more than a decade past the menopause. HRT is generally started in the early fifties, for symptoms. The trial population and the treated population were not the same people.
The formulation was not what is used today. The trial used conjugated equine oestrogens with medroxyprogesterone acetate, taken orally. Contemporary practice more often uses transdermal 17β-estradiol with micronised progesterone — different molecules, delivered by a different route, with a different risk profile.
The starting point matters enormously. This is now called the timing hypothesis: starting hormone therapy close to menopause, in a woman whose arteries are still relatively healthy, appears to carry a different risk-benefit balance from starting it in a woman a decade or more past menopause, in whom atherosclerotic plaque may already be established. Broadly, the window of most favourable benefit is within ten years of the final menstrual period, or before age 60.
The long-term follow-up of the same trial is illuminating. After more than twenty years, women who had taken oestrogen alone (those who had had a hysterectomy) had a lower breast cancer incidence than those on placebo — a 22% relative reduction — and lower breast cancer mortality. Women who had taken combined oestrogen plus progestogen had a higher breast cancer incidence, with a hazard ratio of 1.28, but no statistically significant difference in breast cancer deaths.
That is a far more nuanced picture than “HRT causes breast cancer” — and it was available years before the label changed.
What the risks genuinely are
I do not think the honest response to an over-stated warning is an under-stated one. So here are the risks as I explain them in clinic.
Breast cancer. With combined HRT, the increase is real but small in absolute terms. In the trial data above, annual breast cancer incidence was 0.45% on combined therapy against 0.36% on placebo — a difference of roughly one additional case per 1,000 women per year of use. Risk rises with longer duration and appears to decline after stopping. For perspective, that magnitude of risk is broadly comparable to what is associated with regular alcohol intake or with carrying excess weight — risk factors that generate far less anxiety than HRT does. Oestrogen-only therapy, in women without a uterus, does not carry this increase.
Blood clots. This is where the route of delivery genuinely matters, and it is the most practically useful fact in this article. Oral oestrogen passes through the liver first and increases clotting factor production, raising the risk of venous thromboembolism. Transdermal oestrogen — patch, gel or spray — bypasses that first pass and is not associated with the same increase in clot risk. For women with additional clot risk factors, including obesity, transdermal is the preferred route.
Stroke. A small absolute increase with oral preparations, again lower with transdermal.
Dementia. The concern arose from the trial’s older participants. There is no good evidence that HRT started around the time of menopause increases dementia risk, and there is no adequate evidence that it prevents it either. Anyone selling HRT as brain protection is ahead of the data.
What HRT is genuinely good at
Vasomotor symptoms — hot flushes and night sweats. This is what it does best, and the effect is substantial.
Sleep, where sleep disruption is driven by night sweats.
Genitourinary syndrome of menopause — vaginal dryness, discomfort with intercourse, urinary urgency and recurrent urinary infections. Local vaginal oestrogen treats this effectively with minimal systemic absorption, and it can be used by many women who cannot or choose not to take systemic HRT.
Bone. HRT reduces fracture risk and preserves bone mineral density. This is a genuine, evidence-supported benefit that is frequently forgotten.
And now the part that matters just as much:
HRT is not an anti-ageing treatment. It does not extend lifespan, and it is not licensed or evidenced as a longevity intervention.
HRT is not a weight loss treatment. It may help with the symptoms that make weight management harder — poor sleep, low energy, low mood — but it is not a treatment for weight gain.
HRT is not a general energy or performance therapy. If fatigue is the dominant symptom, thyroid disease, iron deficiency, sleep apnoea and depression need to be excluded first.
I am specific about this because the gap between what HRT treats and what it is sold as has become wide, and closing it is part of giving good advice.
Who should still be cautious
HRT is not appropriate, or requires specialist discussion, for women with:
- A personal history of hormone-sensitive breast cancer
- Active or recent venous thromboembolism, or a known high-risk thrombophilia
- Undiagnosed vaginal bleeding — which must be investigated first
- Active liver disease
- Untreated hypertension, which should be controlled first
- A history of oestrogen-dependent malignancy
None of these is automatically an absolute and permanent bar in every case. Each is a reason for a proper individual conversation, sometimes involving your oncologist or haematologist, rather than an automatic no — or an automatic yes.
The non-hormonal options also improved
For women who cannot or prefer not to take hormones, the options are better than they were.
Neurokinin receptor antagonists — fezolinetant, and elinzanetant, approved in 2025 — target the brain pathway that generates hot flushes directly. They are the first genuinely effective non-hormonal treatments for vasomotor symptoms, rather than repurposed antidepressants.
Cognitive behavioural therapy has reasonable evidence for reducing the impact of hot flushes and for sleep.
What does not have good evidence, despite energetic marketing: most herbal preparations, “hormone balancing” supplements, and bioidentical compounded creams. On that last one, see bioidentical versus body-identical hormones.
What this means practically for women in Dubai
Menopause care here is fragmented. Hot flushes go to a gynaecologist, low mood to a psychiatrist, joint pain to a rheumatologist, and weight gain to an aesthetic clinic — and nobody assembles the picture. Meanwhile the average woman in Dubai is often far from the family and friendship networks that carry women through this transition elsewhere.
Practically: transdermal oestradiol and micronised progesterone are available in the UAE. Insurance coverage for menopause care is inconsistent and worth checking before you start. And there is a real difference between hormone therapy prescribed and monitored by a physician trained in endocrinology or menopause medicine, and hormone therapy sold as part of a wellness package.
Frequently asked questions
Is HRT safe now that the black box warning is removed? The evidence did not change in November 2025 — the way it is communicated did. For most healthy women starting within ten years of menopause or before age 60, the benefits of HRT for troublesome symptoms outweigh the risks. That was true before the label changed. It remains an individual assessment.
Does HRT cause breast cancer? Combined oestrogen-plus-progestogen therapy is associated with a small increase in breast cancer incidence — roughly one additional case per 1,000 women per year of use — which rises with duration and falls after stopping. Oestrogen-only therapy in women without a uterus was associated with lower breast cancer incidence and mortality in long-term trial follow-up.
What is the safest form of HRT? For most women, transdermal 17β-estradiol (patch, gel or spray) combined with micronised progesterone where a uterus is present. The transdermal route avoids the clot risk associated with oral oestrogen.
How long can I stay on HRT? There is no arbitrary time limit. The old advice to stop at five years is not evidence-based. Continuation should be reviewed at least annually, weighing ongoing symptom benefit against individual risk.
Is it too late to start HRT if I am past 60? Starting more than ten years after menopause or after age 60 shifts the balance of risk and benefit, particularly for cardiovascular risk. It is not an absolute prohibition, but it requires a more careful individual assessment — and local vaginal oestrogen for genitourinary symptoms remains appropriate at any age.
Get an individual answer, not a headline. Whether HRT is right for you depends on your symptoms, your history and your own risk profile — not on a regulatory announcement. Book a menopause assessment with Dr. Ali Aldibbiat, Consultant Endocrinologist, at Newcastle Vitality Clinic, Jumeirah.