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Further advice on safety of Hormone Replacement Therapy (HRT)

  • Published date:
    3 December 2003

Hormone replacement therapy (HRT) is no longer recommended as first choice of therapy for prevention of osteoporosis, according to new advice from the Medicines and Healthcare products Regulatory Agency(MHRA).

This follows a European-wide review of the balance of risks and benefits of HRT in response to growing concerns about the safety of HRT in long-term use. The review found that:

  • For the treatment of menopausal symptoms, HRT is beneficial in the short-term. The minimum effective dose should be used for the shortest duration.
  • The balance of risks and benefits of HRT when used in the long-term for preventing osteoporosis, suggest that it should not be the first choice of therapy.
  • HRT is of no benefit in healthy women without symptoms.

Chairman of the Committee on Safety of Medicines, (CSM) Professor Gordon Duff, said:

"The CSM has issued new advice on the safety of HRT as new information has become available, most recently following publication of the Million Women Study in August. The Committee endorses the conclusions of this review and agrees that HRT remains an effective treatment for the short-term relief of menopausal symptoms but that it should no longer be considered as the therapy of choice for preventing osteoporosis, in women over the age of 50 years.

"These latest recommendations should come as no surprise to most clinicians in the UK. While this new advice does not require any urgent change in treatment, women who are currently receiving HRT as long-term prophylaxis should have their treatment reviewed at the next routine appointment. The CSM is keeping the safety of osteoporosis treatments, including HRT, under continual review, and will issue further advice as necessary".

Recommendations for prescribers are:

  • For the treatment of menopausal (climacteric) symptoms that adversely affect quality of life the balance of risks and benefits of HRT is generally favourable. However, the lowest effective dose should be used for the shortest possible duration; each decision to start HRT should be made on an individual basis with a fully informed woman; and treatment should be re-evaluated at least annually in light of new knowledge and any changes in a woman's risk factors.
  • For the prevention of osteoporosis in women over 50 years of age, and with an increased risk of fracture, the balance of risks and benefits of HRT is such that it should no longer be the first choice of treatment. While HRT remains a treatment option for those who cannot use other osteoporosis prevention therapies or for whom other therapies have been shown to be ineffective, such a treatment decision should be made with care.
  • For younger women who have experienced a premature menopause (due to ovarian failure, surgery or other causes) HRT may be used to treat their menopausal symptoms and to prevent osteoporosis until the age of 50 years. After this age, therapy for preventing osteoporosis should be reviewed and HRT considered a second-line choice.

Findings from previous studies indicate that HRT is associated with a duration-dependent increase in the risk of breast cancer, endometrial cancer and ovarian cancer. In addition, HRT is no longer thought to have a beneficial effect on cardiovascular disease and has been shown to increase the risk of heart attacks and venous thromboembolism (VTE or blood clots), especially in the first year, and to increase the risk of stroke. The risk of most of these conditions increases with age therefore increasing the overall risks the longer HRT is taken.

Notes to editor

  1. The review was carried out by a European Expert Group on HRT and included members of the CSM's Expert Working Group on HRT. The recommendations of the Group have been adopted by the European Committee for Proprietary Medicinal Products (CPMP) and endorsed in the UK by the CSM's Expert Working Group.
  2. In the UK, Hormone Replacement Therapy (HRT) products are indicated for the treatment of menopausal symptoms, and approximately half are also licensed for the prevention of osteoporosis.
  3. The CSM is the independent expert scientific committee that advises the Government on the safety of medicines.
  4. The MHRA is an agency of the Department of Health and is responsible for regulating medicines and medical devices.
  5. Further information and advice may be found on the Medicines and Healthcare products Regulatory Agency's website (www.mhra.gov.uk)
  6. Further information is also available on the website of the European Medicines Evaluation Agency (www.emea.eu.int) and the Heads of European Medicines Regulatory Agencies website (http://heads.medagencies.org).
  7. Further information on the role of HRT in clinical practice is available on the website of the Royal College of Physicians (www.rcpe.ac.uk/esd/consensus/hrt_03.html)

For media enquiries only, please contact Alison Langley on 0207 210 5649 or Steve Ryan 0207 210 5226.

  • Contact:
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    020 7210 5221

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