The European Medicines Agency Starts a Review on the Fibroids Drug ESMYA


The European Medicines Agency (EMA) has announced that it is has started a review on the medicine ESMYA (ulipristal acetate). This drug is used to treat fibroids and the review was initiated following four reports of serious liver injury, three of these patients had to have a liver transplant.  An initial assessment of these cases was conducted and it was determined that ESMYA was the cause of the liver damage.  A more comprehensive and in-depth review will now be carried out.

The EMA has advised that women currently on ESMYA should speak to their doctor if they have any questions or concerns.

What is ESMYA?

ESMYA is a prescription drug that was first authorised in the EU for use in patients with fibroids in 2012. It is used to treat moderate to severe symptoms of fibroids and works by stopping the hormone progesterone from stimulating the growth of fibroids and this reduces their size.  It was initially licensed to be used before surgery to shrink fibroids, but can now also be used as a stand-alone treatment. It should only be used for up to three months at a time.  The use of ESMYA can be repeated but there should be breaks between each 3-month course of treatment.

The most common side effects of ESMYA are the absence of a woman’s period and thickening of the lining of the womb. You can speak to your doctor about what all the side effects are and these will be listed in the drug leaflet which comes with ESMYA.

ESMYA must not be used  by women who are pregnant or breastfeeding, have vaginal bleeding or have womb, cervical, ovarian or breast cancer. You can speak to your doctor about other restrictions or these will be listed on the drug information leaflet.

More Information

More information about the assessment can be found in the information sheet below and you can visit the EMA’s website for more information.

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