| Medicines and Healthcare Products Regulatory Agency |
MHRA Press Release, 3 Dec 2003
Further advice on safety of hormone replacement therapy (HRT)
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.
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 Editors
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.
Additional information provided by MHRA:
Message to healthcare professionals
Products in the U.K. affected by this advice
Information sheet for patients
Latest safety update for patients
[all in PDF format]
The text in this article was prepared by the Medicines and Healthcare Products Regulatory Agency (U.K.).