This guideline covers assessing and treating heavy menstrual bleeding. It aims to help healthcare professionals offer the right treatments to women with heavy periods (menorrhagia) that affect their quality of life, taking into account the woman’s individual preferences.
EMA review of ulipristal acetate (Esmya) and temporary safety measures
In February 2018, the European Medicines Agency (EMA) introduced a number of temporary safety measures as part of an ongoing review of ulipristal acetate (Esmya) for uterine fibroids. Further information is available from the EMA website. The temporary safety measures are:
- Do not start new treatment courses of Esmya, including in women who have completed 1 or more treatment courses previously.
- Perform liver function tests at least once a month in all women currently taking Esmya. Stop Esmya treatment in any woman who develops transaminase levels more than 2 times the upper limit of normal, closely monitor and refer for specialist hepatology evaluation as clinically indicated. Liver function tests should be repeated in all women 2 to 4 weeks after stopping treatment.
- Check transaminase levels immediately in current or recent users of Esmya who present with signs or symptoms suggestive of liver injury (such as nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia, jaundice). If transaminase levels are more than 2 times the upper limit of normal, stop treatment, closely monitor and refer for specialist hepatology evaluation as clinically indicated.
- Advise women using Esmya on the signs and symptoms of liver injury.
NICE will review its guidance on heavy menstrual bleeding when the EMA review has concluded. In the meantime, the guidance must be read in conjunction with the temporary safety measures above.
This guideline includes recommendations on:
- history, examination and investigations
- education and information
- choice of treatments
- pharmaceutical treatments
- surgical treatments
Who is it for?
- Healthcare professionals
- Commissioners and providers of heavy menstrual bleeding services
- Women with heavy menstrual bleeding, their families and carers
Is this guideline up to date?
Guideline development process
The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.