THE US Food and Drug Administration (FDA) announced this week it will remove “black box” warnings on menopause hormone therapy (MHT) products, prompting calls in Australia for similar action from the Therapeutic Goods Administration (TGA).

The boxed warnings on MHT products (also known as hormone replacement therapy, or HRT) were introduced after early results from the Women’s Health Initiative in 2002 suggested that hormone therapy increased the risk of breast cancer, heart disease and stroke.

Subsequent analysis has found that those early findings were misinterpreted, and the therapy is safe for most women and helps improve quality of life.

However, numerous research studies have shown that the boxed warnings have discouraged women from taking it, and doctors from prescribing it, with a concomitant drop in HRT sales around the world.

The FDA is requesting that companies make changes to the labelling to provide current, accurate and balanced information about the benefits and risks of these drugs, so women, in consultation with their healthcare providers, can make the best decisions for their health.

Specifically, the FDA is requesting references to risks of cardiovascular disease, breast cancer and probable dementia be removed, although the warning for endometrial cancer for systemic oestrogen-only products is to remain.

Speaking on ABC radio yesterday, Dr Heather Waterfall from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said: “We really think those warnings have been over-exaggerated and removal of the warnings, I think, is an excellent thing for women”.

She recalled prescribing MHT for her own patients, only to have them refuse to take it after reading the warnings in the pharmacy.

In a statement to the ABC, a spokesman for the TGA said that the regulator is “aware of the FDA proposed changes to product labelling and will independently consider the data that’s been used to support its amendments”.

Meanwhile, Healthy Hormones, a GP-led initiative working to improve menopause care across Australia (PD 28 Jul), has launched a petition on Change.Org calling on the Australian Government and the TGA “to follow the FDA’s lead and remove or revise the boxed warning on menopause hormone therapy products so that information reflects the best available evidence”. KB

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