For the past two decades MHT prescribing information warnings have been based on the Women’s Health Initiative (WHI) trials which flagged a concern of increased breast cancer mortality. Other warnings also included risks of cardiovascular disease, thromboembolism and probable dementia.

There was no risk stratification based on age of MHT initiation. More recent studies and analyses have suggested that early initiation of MHT before age 60 or within 10 years of menopause reduces all-cause mortality in the subsequent decade and that this earlier initiation gives a favourable risk-benefit for a much larger population of women. In addition, clinical trials have not demonstrated an increased risk of breast cancer mortality. Recommended prescribing information changes will also be individualized based on the route of administration (topical vs systemic) as well the type of preparation (e.g. oestrogen plus progesterone vs oestrogen alone).

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