The Pharmaceutical Journal
Vol 268 No 7197 p633-640
11 May 2002

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News summary

Patient information leaflet for hormone replacement therapy updated by MCA

An updated patient information leaflet for hormone replacement therapy (HRT) has been produced by the Medicines Control Agency.

The leaflet summarises the latest information about HRT and is to be included in each HRT pack.

Included in the new information is a statement that HRT should not be used to prevent coronary heart disease. Women who have previously had angina or a heart attack are advised to discuss the risks and benefits of using HRT with their doctor. HRT is not advised for women with current heart disease. The leaflet adds that the long-term effect of HRT on heart disease is unknown and that trials are ongoing in this area.

The new leaflet states that women who use HRT are at slightly increased risk of developing a blood clot. The risk is increased from about one case in 10,000 women to three in 10,000 among women taking HRT. It adds that women who are going to have an operation might be advised to stop taking HRT four to six weeks before surgery and should discuss this with their surgeon. The leaflet lists warning symptoms of venous thromboembolism and advises women who develop these symptoms to stop taking HRT and to consult a doctor immediately. Other symptoms that necessitate seeking medical advice are breakthrough bleeding or spotting that continues after the first few months of taking HRT or that develops after HRT has been taken for some time. These symptoms could suggest endometrial cancer.

The leaflet also considers the slight increase in risk of breast cancer among women who take HRT. The figures given for additional cases of breast cancers found before the age of 70 years are two in 1,000 women for five years of HRT, six in 1,000 for 10 years of HRT and 12 in 1,000 for 15 years of HRT.

Full details of the new patient information leaflet can be found on the MCA website (www.mca.gov.uk).