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Safety alert after women are prescribed high doses of oestrogen

The Royal College of GPs has issued a safety alert after increasing numbers of women are being initiated on high doses of oestrogen, which exceed the product licenses and are not in line with any clinical guidelines.

The Royal College of GPs has issued a joint safety alert after increasing numbers of women have been initiated on high doses of oestrogen, which exceed the product licenses and are not in line with any clinical guidelines.

The alert has been issued with the British Menopause Society, Faculty of Sexual and Reproductive Health, Royal College of Obstetricians and Gynaecologists, Society for Endocrinology and Royal College of Nursing’s Women’s Health Forum on menopause care.

In a joint statement, they said that the safety alert had been produced in response to questions raised in relation to appropriate doses of oestrogen and progestogen provided to women experiencing symptoms of menopause. The guidance from NICE and MHRA is to aim for the lowest effective dose to control symptoms.

It added that oestrogen should not be regularly prescribed in doses higher than the upper limit listed in the individual Summary of Product Characteristics (SmPC) as these limits are informed by the results of clinical trials, to ensure patient safety.  If in exceptional circumstances a higher than licensed dose is deemed necessary for symptom control, informed consent should be obtained according to good medical practice guidance and patients must be made aware that treatment falls outside of reassuring safety evidence.  In addition, the dose of progestogen should be increased proportionately.

Oestrogen and endometrial cancer

Professor Kamila Hawthorne, Chair of the Royal College of GPs, said: “The College has recently co-signed a safety alert with other members of the British Menopause Society, following our concerns about an increasing number of menopausal women being prescribed oestrogen at a dose that is higher than clinical guidelines.

“GPs take the menopause and perimenopause extremely seriously and always consider the different factors potentially affecting an individual’s health and wellbeing when developing a treatment plan. HRT can effectively treat the most severe menopausal symptoms, and GPs are highly qualified to have frank and sensitive conversations with patients about its risks and benefits. Menopause is included in the RCGP curriculum which all GP trainees need to demonstrate competency of in order to practise independently as a GP in the UK. We also undertake lifelong continuing professional development and have to demonstrate ongoing learning across the curriculum to continue to practise.”

The joint statement highlighted that there is  good clinical evidence in relation to the dose of progestogen required, alongside licensed doses of oestrogen, to adequately protect the endometrium against hyperplasia with atypia, a risk factor for endometrial cancer.

It said: “Endometrial cancer is becoming more common in association with rising obesity and effective endometrial protection is more important now than ever.  Routine use of minimal/insufficient doses of progestogen should therefore be avoided. Progestogen intolerant patients receiving lower doses of progestogen (with informed consent) require regular endometrial surveillance in specialist centres with direct access to ultrasound, endometrial biopsy, and hysteroscopy if required.”

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