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The Pharmaceutical Journal
Vol 271 No 7279 p803
13 December 2003

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CSM adviser stands down over latest HRT warnings

An adviser to the Committee on Safety of Medicines has stood down from his position on an expert working group following the committee's latest recommendations on hormone replacement therapy (HRT).

Professor David Purdie, a consultant to the Edinburgh Osteoporosis Centre, disagrees with CSM advice that HRT should no longer be recommended as first-line therapy for the prevention of osteoporosis (PJ, 6 December, p768). He told The Journal: “I took the view that HRT should be retained as first-line treatment for younger women. But I did not persuade the committee.”

The CSM recommendation states that HRT should be an option only for women who are unresponsive or intolerant of other osteoporosis prevention therapies, or for women in whom such therapies are contraindicated. The advice is based on a review of recent studies looking at the long-term risks and benefits of HRT. The studies provide increasing evidence that long-term HRT use is associated with an increased risk of certain cancers. The review concludes:

• The risk:benefit ratio of HRT is favourable for treatment of menopausal symptoms (the minimum effective dose should be used for the shortest duration)
• The risk:benefit ratio of HRT is unfavourable for prevention of osteoporosis as first-line use
• In healthy women without symptoms, the risk:benefit ratio of HRT is generally unfavourable

The conclusions and CSM advice apply to all conventional oestrogen-only and combined (oestrogen plus progestogen) HRT products licensed for the prevention of osteoporosis.

In a letter to health care professionals, including prescribing advisers, community pharmacists and medical information pharmacists, Professor Gordon Duff, chairman of the CSM, said: “This new advice does not necessitate any urgent changes but women currently receiving HRT as long-term prophylaxis should have their treatment reviewed at the next appointment.”

A spokeswoman for the Department of Health told The Journal that there were no plans to withdraw the CSM advice following Professor Purdie’s resignation.

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