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New HRT warning on dementia 'will confuse GPs and patients'

By Rob Finch

The Government's drug watchdog is set to order HRT manufacturers to warn patients of the risk of dementia following results from a major US study.

But GPs fear the warning will add to the confusion over HRT and the Department of Health has questioned its relevance in the UK.

The Medicines and Healthcare Products Regulatory Agency said the study showed the risk of dementia doubled in HRT users over 65.

Action was taken following a thorough evaluation of the Women's Health Initiative Memory Study (WHIMS). The study, published in May last year, concluded a combination of oestrogen and progestin increased the risk of dementia and failed to prevent cognitive impairment in the over-65s.

The results showed 60 out of 4,500 women were diagnosed with dementia and of these, 65 per cent were in the oestrogen-progestin group.

The agency said a Europe-wide update of HRT product information was in progress and added: 'A warning about the risk of probable dementia in women who start HRT after the age of 65 will be included in product information.'

The US medicines watchdog, the Food and Drug Administration, last week order-ed HRT manufacturers to include details of the doubled risk of dementia in the 'black box' information alongside the well-known cardiovascular and carcinogenic risks.

The department said the warning was unlikely to cause widespread concern because the 'vast majority' of women in the UK started HRT in their 50s and had stopped using it by 65.

The risk of dementia was questioned in a different US study published this month in the Journal of the American Geriatrics Society which showed no significant difference in

cognitive function between elderly users and non-users of HRT.

Dr Anthony Seeley, a GP in Bridgnorth, Shropshire, and a council member of the British Menopause Society, said the warning would just confuse GPs and patients.

He said the US trial data was based on older women using products not licensed in the UK and added dementia was less important than other potential risks.

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