HRT users to discuss its risks and benefits at their next routine appointment as new study highlights persistent risk of breast cancer

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This is because a new study, published by The Lancet, has confirmed that women who use HRT for longer than 1 year have a higher risk of breast cancer than women who never use HRT. This known risk of breast cancer gets lower once HRT is stopped, but the new study shows some increased risk remains for more than 10 years compared to women who have never used HRT. The increased risk of breast cancer is seen with all types of HRT, except for topical HRT applied directly onto or into the vagina.

There is no need for urgent action but women who use, or are planning to use, HRT should be aware of these new findings when considering their HRT use at their next routine appointment. Women who have previously used HRT should be vigilant for signs of breast cancer and see a doctor if they notice any changes in their breasts. It is also important for all women to go to breast screening when invited.

The MHRA advises that HRT should only be initiated for relief of menopausal symptoms that adversely affect quality of life.

Women should use the lowest effective dose of HRT for the shortest duration and HRT should only be continued as long as the benefit in alleviating menopausal symptoms outweighs the risks associated with treatment. In all cases, a careful appraisal of all the risks and benefits should be undertaken regularly, as a woman’s need for treatment and chance of side effects changes over time. Each women’s risk will depend on what type of HRT is used and how long it is used for. Your doctor or nurse can tell you more about your risks

Sarah Branch, Deputy Director of MHRA’s Vigilance and Risk Management of Medicines (VRMM) Division said:

“Women should be aware of this new information, so that it can be considered with the other risks and benefits of using HRT.

“The menopause can have unpleasant side effects and HRT products can be effective in helping to ease the symptoms.

“No medicine is completely without risk, but it is important for women to be able to make an informed decision about the risks and benefits that are appropriate for them.

“If you have any questions please talk to your healthcare professional.

“The Medicines and Healthcare products Regulatory Agency (MHRA) is communicating this new evidence to patients and healthcare professionals.”

Notes to Editor

  1. Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.

  2. Article in The Lancet

  3. MHRA Drug Safety Update on further information about Hormone replacement therapy (HRT)

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