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Esmya: no new treatment courses prescribed until further notice

Temporary safety measures have been introduced whilst the EMA review is ongoing following a further case of serious liver injury requiring liver transplant.

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In December 2017, the European Medicines Agency started a review of Esmya (Ulipristal acetate) for uterine fibroids after it was reported that four cases of serious liver injury had occurred after its use. In three of the cases a liver transplant was needed.

As of February 2018, temporary safety measures have been introduced whilst the review is ongoing following a further case of serious liver injury requiring liver transplant.

The advice is that no new treatment courses should be prescribed until further notice. Those who are already taking Esmya or have recently stopped, it is advisable that they have blood tests to monitor their liver function at least once a month whilst taking the medicine. Treatment with Esmya will be stopped if these blood tests show signs of a possible problem.

If women experience symptoms associated with liver problems (nausea, vomiting, feeling ill, lack of appetite, weakness, upper abdominal pain, yellowing of the skin/eyes) then they must stop treatment and seek medical attention immediately.

Esmya is used to treat moderate to severe uterine fibroids in adult women who have not yet reached the menopause. It is normally taken for up to three months but the course can be repeated.

It’s important to note that there are no concerns for individuals who have taken the emergency contraception ellaOne which also contains Ulipristal acetate. EllaOne is a single use medicine and as no cases of serious liver injury have been reported with its use to date there are currently no similar concerns with this medicine.

Further information about the EMA Review.

Published 16 February 2018