§ Sandra Gidley: To ask the Secretary of State for Health what assessment he has made of the link between hormone replacement therapy and an increased risk of (a) stroke and (b) heart disease; and if he will make a statement. [161927]
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§ Miss Melanie Johnson: The Committee on Safety of Medicines (CSM) and its expert working group on hormone replacement therapy (HRT) has kept the safety of HRT under constant review and provided targeted advice to women and health professionals in response to important new evidence as it has emerged.
Despite some weak observational evidence suggesting a possible benefit, HRT has never been licensed for the prevention of heart disease in the United Kingdom. In 2002, two large studies in the United States provided important new clinical trial information about the effect of combined oestrogen plus progestogen HRT on the risk of heart disease in women with and without a pre-existing heart condition. One of these studies further demonstrated an effect of HRT on the risk of stroke. Immediately upon publication of this study, the CSM informed health professionals and women that HRT had not been proven to be beneficial in preventing coronary heart disease and may in fact result in a small 1135W increase in the risk in the first year of use. The CSM also advised that this type of HRT causes a small increase in the risk of stroke.
Clear warnings about the risk of heart disease and stroke in association with combined HRT use have been agreed throughout Europe and are being included in the summary of product characteristics for health professionals and the patient information leaflet that accompanies each pack of medicine.
In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) has placed a comprehensive review of the risks (including heart disease and stroke) associated with HRT use on its website. Detailed information has also been published in the safety bulletins issued by the MHRA and the Chief Medical Officer, which are available on their respective websites.
The CSM's expert working group on HRT has been informed that the oestrogen-only arm of the US Women's Health Initiative trial has now found that the risk of stroke in users of this HRT preparation is increased similarly to combined HRT. These findings have not yet been published, but will be urgently considered by the CSM and its expert working group on HRT as soon as they are available. When their review is complete, the current product information will be updated as necessary and women and health care professionals will be clearly informed of the new advice.
The CSM advises that for the alleviation of menopausal symptoms, health professionals should prescribe the lowest effective dose of HRT for the shortest possible time and perform regular health checks on HRT users, including a reassessment of the need to continue HRT on an annual basis. The CSM also advises that for the prevention of osteoporosis, HRT should only be used by women who are intolerant of, or contraindicated for, other medicines approved for this purpose.