Outdated HRT warnings leave women fearing ‘they’ll be dead by bedtime’

·4-min read
Beverly Ellis says she suffered 11 years of debilitating symptoms because doctors would not prescribe her HRT - John Robertson
Beverly Ellis says she suffered 11 years of debilitating symptoms because doctors would not prescribe her HRT - John Robertson

Hormone replacement therapy leaflets are carrying outdated cancer warnings that put the “fear of God” into women, doctors have claimed.

Leaflets for some HRT products, such as those administered via patches, gels and sprays, include warnings that the drugs increase the risk of breast cancer, blood clots and heart disease.

But some doctors claim the information does not reflect the current evidence of the risk of taking the drugs, versus the benefit of relieving the debilitating symptoms of the menopause.

Their criticisms come 20 years after the publication of the Women’s Health Initiative (WHI) study, which linked HRT to an increased risk of breast cancer and other adverse events.

Prescription rates plummeted following the 2002 study, which was later proved to have been misinterpreted.

Doctors say the formulation of HRT products, and the available evidence of the potential risks, is now “light years” away from 2002.

Advice is ‘virtually nonsense’

One patient leaflet, seen by The Telegraph, for an oestrogen-only patch states “HRT may increase the risk of blood clots in the veins”, and that combined oestrogen-progestogen or oestrogen-only HRT “increases the risk of breast cancer”.

Two further leaflets, one for a different brand of patches and one gel, cited the same breast cancer warning.

Dr Anne Henderson, a consultant gynaecologist and British Menopause Society accredited specialist, said the leaflets were “virtually nonsense” and have “not kept up” over the last two decades.

Dr Henderson said: “Specialists like myself virtually say to their patients ‘don’t even bother reading them, I’ll give you my side effects leaflet and I wouldn’t bother reading that’.

“You would read these leaflets and you would think ‘if I put as much as one drop of gel on I’ll be dead by bedtime’.”

Some women prescribed HRT through the GP may only have five or 10 minutes to discuss the risks versus benefits, Dr Henderson said.

“They don’t have time to cover things in detail, so they may just say, ‘read the leaflet, and off you go’. The leaflet would honestly put the fear of God into anyone,” she said.

Dr Louise Newson, a GP and menopause specialist, said: “Before that [WHI] study came out, HRT prescribing was about double what it is now, so we still haven’t gone back to how we were before that study came out, and that is horrendous.”

More than 500,000 HRT prescriptions are being issued in England every month, up from 238,000 five years ago, figures show.

Dr Newson said she has been emailing NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) for years about the “inaccurate” labels but “nothing’s happened”.

MHRA approves all packaging and labelling information for medicines sold in the UK.

An MHRA spokesperson said they kept the safety of all medicines under review “to ensure that the benefits outweigh any risks and that the leaflets provided with medicines in the UK are up to date”.

A summary of evidence by the National Institute for Health and Care Excellence (Nice), published in 2019, said the increased risk of breast cancer from HRT depended on the length of time patients took the drugs, and whether it was oestrogen-only HRT or combined HRT.

Nice recommended doctors explain to women that “HRT with oestrogen alone is associated with little or no change in the risk of breast cancer and HRT with oestrogen and progestogen can be associated with an increase in the risk of breast cancer”.

Paul Pharoah, professor of cancer epidemiology, University of Cambridge, said the risk versus benefit of taking HRT should be an individualised decision, and patients should not rely on manufacturers’ leaflets alone.

Leaftlets take ‘defensive’ stance

Evidence suggesting there was an increased risk of breast cancer from taking HRT had been “complicated” over the years, he added.

At the end of the 2000s, some drug companies were taken to court by women claiming HRT products caused their breast cancer, Prof Pharoah said.

“So one of the things about the leaflets … is that, in a sense, they’re defensive,” he explained.

“If [companies] warn about the risks of things, then they can’t be taken to court later for not warning about them.”

Prof Pharoah added that the 2002 study had a “dramatic effect” and caused an “overcorrection” of prescribing rates in the UK.

“After the WHI was published, the fear was over-egged, and people stopped prescribing,” he added.

“It feels to me like it’s more balanced now… It seems reasonably clear that most doctors have a view that symptoms can be bad and that HRT can help.”

Dr Amit Aggarwal, of the Association of the British Pharmaceutical Industry, said: “Companies make every effort to make sure the information they provide to patients about a medicine is correct. Working with the UK’s medicine regulator, information is updated to reflect changing evidence, considering all available evidence and resolving any differences of opinion, which can take some time.

“It’s important that all patients discuss their treatment options with their health professional to find the one that’s right for them.”

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