On 9th February the Medicines and Healthcare Products Regulatory Agency (MHRA ) released a set of temporary safety recommendations, for healthcare professionals, on the fibroids drug ESMYA. This action was taken by the MHRA following reports of the serious liver injury in four women taking ESMYA.
The MHRA have made the following recommendations:
- Do not initiate new treatment courses of EMYA, including in women who have completed one 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.
They noted that there have been no reports of liver injury with ellaOne, a emergency contraceptive pill, which contains ESMYA. Therefore, there are no safety alerts for this medicine.
Currently the European Medicines Agency (EMA) are currently conducting a review of EMSYA and will provide an update in the near future.
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.
For more information you can download the EMA’s information sheet for healthcare professionals and the MHRA’s full letter issued to healthcare professionals below.