This month in a landmark decision in the U.S., the Food and Drugs Administration (FDA) announced it will remove the black box warnings on Menopausal Hormone Replacement Therapy (MHT) products. MHT (also known as HRT) products are often used to help manage side effects of menopause, including hot flashes, night sweats and vaginal dryness.

The boxed warnings on MHT products were included after studies in 2002 which found some links between certain types of oestrogen used in hormone therapy and increased risks of breast cancer, heart disease and strokes, however more recent research contradicted these early findings. In fact, it has since been proven that MHT is often safe and effective in helping to improve quality of life for most women, especially when administered in the ten years before the onset of menopause.

The decision to remove the prominent safety warnings on products, was made after the FDA concluded the safety warning no longer reflects the modern evidence about the benefits of hormone replacement. The 2002 research was also carried out on women who were in their early sixties, with an average age of 63, and many were past menopause when they started the therapy¹.

Research indicates that beginning hormone replacement therapy within ten years of menopause can offer significant health benefits that generally outweigh potential risks for most women. These benefits include lower rates of overall mortality and bone fractures, a 50% reduction in heart attack risk, a 64% decrease in cognitive decline, and a 35% lower risk of Alzheimer’s disease.

In Australia, many organisations are calling for a similar decision from the Therapeutic Goods Association (TGA). On 12 November, the TGA promised to review the same evidence that led the US health officials to decide to drop the warnings on menopausal health treatments and said it will keep the Australian community informed on its response².