Menopause misconceptions in general practice: the FDA warning change, perimenopause, breast risk in absolute terms, Mirena, oral oestrogen and brain fog

Chair

Introduces herself as Danielle (as transcribed), a GP from Adelaide (transcribed "asleep from Adelaide"). The name "Jane Elliot" is also spoken during the introductions, and one panellist later addresses the chair as "Jane", so the chair's name is uncertain.

Panellist addressed as "Terry"

Introduced as "Dr Larry Frau" (as transcribed), who "kindly stepped in" for "Dr Sonjax" (as transcribed). The introduction that follows (a conjoint senior lecturer in the School of Women's and Children's Health at UNSW, transcribed "Muni", and a current board member of the Australasian Menopause Society) appears to describe this panellist, but the wording is ambiguous. Throughout the session this panellist is addressed as "Terry". Spoke on the FDA change, cardiovascular evidence, breast risk and iPrevent, the levonorgestrel IUD, oral oestrogen, dementia and bone.

Panellist "Marita" (also transcribed "Mahritha")

Dr Marita Long (as transcribed), a Victorian GP in clinical practice, research and education with a strong interest in women's health and cognitive health; a committee member for an organisation transcribed as "ASPOC" and president-elect of the Australasian Menopause Society (transcribed "Australasian Management Society"). Spoke on testing, duration, the menopause item number, GLP-1 medicines, breast density, brain fog and ADHD.

Panellist "James"

Dr James Brown (as transcribed), a gynaecologist with a focus on reproductive technology, working at an institute transcribed as the "Women's Health and Research Institute of Australia" in Sydney, establishing what was described as Australia's first 100% virtual public menopause hub, and doing a PhD in health economics. Spoke on the risks of not taking MHT, fezolinetant, the pill in perimenopause, continuous regimens, the levonorgestrel IUD and mood, progestogen dosing, brain fog and progesterone for sleep.

Session context

Otter title Menopause Management Seminar · id 25i-YRvDmWJfr9INIGSaXKiqnfE · ~47 min (the last minute is the introduction to a separate acne scarring talk, not covered here). A HealthEd-style GP education day. The chair said the panel would use some trade names for clarity; only those clearly spoken are used below.

Key messages for GPs

• The US label change is not a licence for everyone. The panel criticised the process and the lumping of all MHT together; vaginal, transdermal and oral therapies carry different risks.
• No essential test before MHT in women aged about 45 to 55: it is "history, history, history". You can start MHT while cervical screening or mammograms are caught up.
• MHT stays the gold standard for vasomotor symptoms in healthy women started early. Neurokinin-targeted therapy (fezolinetant) is an option when MHT is unsuitable or unwanted, but cost and evolving safety counselling are real issues.
• No mandatory stopping time. Duration is negotiated with each woman.
• Do not prescribe MHT just to prevent heart disease or dementia. Point women to blood pressure, statins and lifestyle, which are proven.
• Early perimenopause: hot flushes plus a change in menstrual flow may be enough, even with a regular cycle length (per a recent Australian study).
• In perimenopause with migraine or PMDD-type mood symptoms, a contraceptive pill that stops ovulation can work better than MHT, which does not stop the hormonal zigzag.
• Talk absolute risk. Tools like iPrevent produce pictograms; the levonorgestrel IUD breast risk was quoted as 30 to 38 cases per 100,000 women per year.
• Oral oestrogen is a reasonable option for many younger, low-risk women; prefer transdermal with migraine, a strong family history of heart disease, or smoking.
• Brain fog is real but not dementia. Global cognition is intact.

Myth 1: the FDA says MHT is fine for everyone

The chair recapped the history: before the Women's Health Initiative (WHI) about 25 years ago, MHT was popular for symptoms and for preventing heart disease, osteoporosis and dementia. After the 2002 WHI publication, prescribing and research "fell off a cliff". The later position became: women under 60, with symptoms, lowest dose, shortest time, mostly transdermal. Since then practice has been catching up with re-evaluated evidence and body-identical hormones, while social media, celebrity doctors and patients have "overtaken the available research".

In November 2025, as reported in the session, the US Health Secretary Robert F. Kennedy Jr spoke about HRT as the FDA announced removal of the long-standing boxed warnings from menopausal hormone therapy products (warnings about breast cancer, heart disease and dementia based on WHI).

Terry's view: "be careful what you wish for".

• The process looked like it decided the outcome first and "back engineered" it: rushed, some committee expertise questionable, several members with commercial interests, and some appropriate people reportedly left.
• It lumped all MHT together: vaginal oestrogen treated like systemic, transdermal treated like oral.
• It made claims (reduced cardiovascular risk, reduced dementia, and, from the committee head as quoted, even reduced divorce) that the evidence does not support.
• If Australia ever reviews its labelling, it needs the right process and the right people, including oncologists, or women could be harmed.

Myth 2: not taking MHT is risky

A speaker at an International Menopause Society meeting asked "what are the risks of not taking MHT?" James's answer for patients: the longevity benefits promoted online are marginal at best when you drill into the data, especially in asymptomatic women. The "original sin" of WHI was giving hormones to women who did not need them. Show her the data; if she still wants it, he is happy to prescribe and follow up, but caution is warranted.

Myth 3: you need tests before starting

• Marita: there is no essential test. Most women ask to have their hormones checked, but for women going through menopause at the usual age (45 to 55) it is a clinical diagnosis from history.
• Consider testing in women under 45 (or under 40).
• Tests may be needed for heavy menstrual bleeding or unexplained bleeding, or to assess cardiovascular risk.
• Screening not up to date? If she has had significant symptoms for a long time, start MHT and make catching up on cervical screening and mammography part of the plan at review, usually in about two to three months. The other panellists agreed.

The new IMS recommendations: non-hormonal options, duration, the heart

The chair picked out items from the International Menopause Society's recent paper of recommendations and key messages on midlife health and menopause (29 recommendations; "mostly no surprises").

Neurokinin-targeted therapy

MHT remains the gold standard for vasomotor symptoms in healthy women when started early. Neurokinin-targeted therapies are recommended when MHT is inappropriate or unwanted. In Australia one is available, fezolinetant (transcribed "Fesolinitan"). James:

• One tablet a day; about 70% of women's hot flushes reduce in frequency or intensity (as spoken), and you know within the first week whether she responds.
• Fewer side effects than older non-hormonal options such as oxybutynin or gabapentin.
• But the cost is high compared with very affordable MHT, and new safety information keeps emerging: liver enzyme checks are needed, and a recent paper raised a possible cancer signal that is being looked into (the cancer type was garbled; see caveats). Counselling is the sticking point, so he often still uses the older medicines.

How long can she take MHT?

The paper sets no mandatory stopping time. Marita: the old "lowest dose for the shortest time" line has been superseded. Every woman's symptoms and their duration differ, so it is a negotiation with regular check-ins. Some taper on their own or notice they forget doses and feel fine; others stay on longer because symptoms are severe.

The heart: what the paper says, and what to tell patients

As read out: in women under 60, recently postmenopausal, without cardiovascular disease, oestrogen therapy reduces coronary heart disease and all-cause mortality; with a progestogen the data are less convincing; doctors should consider these potential benefits when initiating MHT; but using MHT solely for primary prevention of coronary heart disease is off-label.

• Terry: a good committee, but there is no decent randomised trial on this question. You would need to follow young women for about 20 years. Trials rely on surrogates such as lipid lowering or carotid intima thickness, which may not translate into long-term benefit.
• Most evidence is observational, with differing results: "this looks interesting" at best.
• Young woman with other reasons for MHT: probably safe from a cardiovascular point of view, but you cannot promise it lowers her risk.
• Older woman who never used it and feels she is "missing out": starting late may do more harm than good. Those in between need individual risk assessment.
• For cardiovascular risk reduction, use what works: blood pressure control, statins and lifestyle change.

The menopause item number and consult time

The AMS document Menopause in Focus highlighted that doctors consistently struggle with insufficient consult time. There is now a Medicare item for a menopause health assessment (referred to later as item 695, as spoken). Only two hands went up when the chair asked who uses it.

Marita: it is a fairly detailed health assessment to fit into 20 or 30 minutes. It works very well for regular patients you know well, perhaps postmenopausal ones. Most of her consults are complex and layered and take about 45 minutes. Investing that time up front (so she knows, for example, exactly where and how to apply the gel or vaginal oestrogen) means fewer troubleshooting visits later. The panel ran a survey on how useful the item has been, to feed back to decision makers.

Diagnosing early perimenopause

Postmenopausal women (12 months without a period, then hot flushes) are easy. Most of the room found early perimenopause harder. Under the STRAW criteria, perimenopause needed a persistent change in cycle length of seven days or more (for a 28-day cycle, a 21- or 35-day cycle) or a missed cycle. Younger women with symptoms but regular cycles were often sent away.

A recent Australian study (transcribed "Australian Midlife Year Study", published last year; lead author Professor Susan Davis) was described as a game changer: if a woman has some hot flushes, all she needs is a change in menstrual flow (lighter or heavier), not a change in cycle length.

Why the pill can beat MHT in perimenopause

For younger women in early perimenopause whose main problems are worsening menstrual migraine without aura or worsening mood or PMDD, the panel suggested a combined oral contraceptive pill if there are no contraindications (or another option transcribed as "slender off-label", plus or minus added oestrogen; both unclear), rather than MHT. James explained why:

• Menopause is the absence of ovulation. Perimenopause is the presence of abnormal ovulation: a redistribution of hormones, not a deficiency.
• Hormones rise and fall sharply, which triggers migraine, abrupt luteal-phase mood symptoms, and vasomotor symptoms "in the gutters".
• The pill stops ovulation and levels everything out. "I promise we're doing this for the right reason."
• MHT does not stop ovulation, so it adds oestrogen on top of the zigzag without smoothing it.

Talking about breast cancer risk

Use absolute rather than relative risk, and pictures. Terry recommended iPrevent (transcribed "eye prevent"), a validated online tool that uses family history, hormone use and lifestyle factors and produces a pictogram of her personal risk. It takes about 30 minutes, so ask her to do it at home and bring it back to discuss.

Pictograms also show how many women did not get breast cancer, which surprises patients. Still, no MHT is "no risk"; it is a very small risk, often smaller than alcohol or other risk factors. And when asked "do you believe in HRT?", the chair's reply: nobody asks if she believes in asthma treatment; what she believes in is giving women information and letting them decide.

Cyclical or continuous? Bleeding and GLP-1 medicines

• Guidelines: perimenopausal women (not yet 12 months without a period) use cyclical MHT: continuous oestrogen plus a progestogen for 12 to 14 days a month. Postmenopausal women use continuous combined therapy.
• Why not continuous in perimenopause, if she accepts spotting? James: continuous progestogen in perimenopause has not been studied for endometrial safety (hyperplasia and cancer), and oestrogen exposure varies a lot through the month; the withdrawal bleed is a "safety net" that resets the lining. Practically, irregular bleeding on continuous therapy obliges you to investigate. Hence the recommendation to avoid continuous regimens here.
• Breakthrough bleeding: a levonorgestrel IUD (Mirena) may control it better.
• GLP-1 and similar weight-loss injectables: concern comes from combined pill data, where slowed gastric emptying may reduce absorption. A British Menopause Society fact sheet suggests increasing the progestogen when starting or increasing the dose of these medicines (the drug name was garbled). Marita: there is no robust evidence for this, so she monitors; if bleeding occurs she investigates as needed and considers the type of progestogen.

The levonorgestrel IUD: not "just local"

Mood

James: even the FDA-approval data show systemic absorption of levonorgestrel from Mirena. It varies; anovulation rates are about 50% in the first year (as spoken), tapering over time. Two mechanisms can affect mood:

• Progestogen intolerance from the absorbed hormone, which may explain some women's bad experiences.
• If it suppresses ovulation, it may tip a perimenopausal woman into a more hypo-oestrogenic, menopause-like state.

Terry added that levels are detectable about 15 minutes after insertion, highest in the first two weeks (about 200 pmol/L), falling to about 100 by five or six years, as spoken. That is much less than a progestogen-only pill, but some women may be exquisitely sensitive. Switching from a combined pill to an IUD also changes cycle control, which can muddy the picture.

Breast cancer

Some breast surgeons tell patients the IUD can stay in after a breast cancer diagnosis because it is "just local". Terry presented a recent large Australian observational study as the worst-case scenario: an odds ratio of 1.26, reported as a "26% increase". In absolute terms the risk rose from 30 to 38 cases per 100,000 women per year, an extra 8 per 100,000.

Breast density

Mammogram reports now include density; the highest category ("D") was described as about 10% of women. Marita: high density is not a contraindication to MHT. It may slightly increase breast cancer risk and make cancers harder to detect, so discuss her risk (iPrevent helps) and screening. Women on MHT take part in breast screening more than women who are not.

Myth 4: oral oestrogen is off the table

Patch supply has been unreliable, and some patches do not stick. Terry: transdermal oestrogen does not raise the background VTE risk, which is why it is preferred, but "perhaps we've been pushing the barrier a little too high".

• For many younger women, background VTE risk is low enough that oral oestrogen is a perfectly good option, and some find it more convenient.
• Prefer transdermal for women with migraine, a strong family history of heart disease, or who smoke.
• On the slide shown, in women aged 50 to 60, VTE risk with transdermal oestrogen was the same as background; older conjugated oestrogens carried the highest risk; oral estradiol and oral estradiol with dydrogesterone carried small extra risks; data for oral estradiol with micronised progesterone are lacking but likely similar. The exact figures were garbled (see caveats).
• For dose equivalents (for example, an oral dose equivalent to a 50 microgram patch), the AMS has an HRT equivalence chart covering products available in Australia.

Progestogen dose with higher oestrogen doses

The British Menopause Society advises higher progestogen doses with higher oestrogen doses, whereas the Australian product information keeps the micronised progesterone dose the same up to four pumps of gel or a 100 microgram patch (as described). What should Australian GPs do?

James: "we might be overthinking it". In a woman who is not bleeding, significant endometrial pathology is very unlikely. As long as she is not bleeding you do not need to investigate or adjust. Bleeding is the trigger: then investigate fully.

Brain fog and dementia

• Many women present fearing dementia; some have even been referred for dementia testing.
• Marita: cognitive changes in perimenopause are well known. There is a dip in verbal recall and memory, but global cognition is intact. Brain fog is not an early sign of, nor a risk factor for, dementia. Acknowledge the symptoms, then support sleep, avoid multitasking and encourage delegating.
• James: put it in social context, including workplace expectations. MHT has only very small, informal evidence for short-term memory and processing. He will sometimes trial it and stop if it does not help, noting a big placebo effect.
• Terry, on "my mum had Alzheimer's, can MHT prevent it?": there is no evidence, whatever the FDA or influencers say. Proven ways to lower dementia risk are harder but have no side effects: exercise, better sleep, making sure eyes and ears are working well, and social engagement.

Bone, sleep and ADHD

MHT for bone

Healthy Bones Australia has a new osteoporosis management position statement. Previously a woman needed menopausal symptoms to use MHT for bone; now, as described, there is TGA approval to use MHT solely for the prevention and treatment of osteoporosis. Terry: it stacks up well against bisphosphonates and denosumab (as we read the garbled "Nozomat"); it works for most women, though not all, has a dual effect on bone turnover (as described), and helps symptoms too.

Micronised progesterone for sleep

Prometrium for sleep, alone or added to a levonorgestrel IUD, is popular. Is the extra progestogen raising breast risk? James: "I don't think we know." He does use it, it "works beautifully", and he thinks a little progesterone is probably no worse than other sleep medicines.

Menopause and ADHD

Marita sees this "definitely" in her consulting room: there is some association with the menstrual cycle, and ADHD medicines may seem less effective. Her approach: a good perimenopause consult first, treat the menopausal symptoms, see what is left, and if there is a legitimate residual concern, offer referral for assessment.

GP clinic checklist

1. Aged 45 to 55 with typical symptoms: diagnose clinically; no routine hormone tests. Test if under 45, abnormal bleeding or for cardiovascular risk.
2. Do not delay MHT for overdue screening; book it into the two to three month review.
3. Early perimenopause: ask about hot flushes and any change in flow, not just cycle length.
4. Perimenopausal migraine or PMDD-type mood: consider a pill that suppresses ovulation (if no contraindications) before MHT.
5. Perimenopausal on MHT: cyclical progestogen 12 to 14 days a month; continuous combined after 12 months amenorrhoea. Investigate unexpected bleeding.
6. Breast risk: use absolute numbers and iPrevent pictograms; high breast density is not a contraindication.
7. Route: oral is fine for many lower-risk women; transdermal for migraine, smokers or strong cardiac family history.
8. Do not prescribe MHT solely to prevent heart disease or dementia; offer proven risk reduction instead.
9. Brain fog: reassure that global cognition is intact; support sleep and workload.
10. Consider the menopause health assessment item for longer consults (check current MBS rules).

Transcript caveats

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