FSRH statement: MHRA places new restrictions to the use of Esmya® (ulipristal acetate)

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert to healthcare professionals about Esmya®. This product contains ulipristal acetate 5mg taken once daily for treatment courses of up to 3 months and is licensed to treat moderate to severe symptoms of uterine fibroids in women of reproductive age. The emergency contraceptive ellaOne® also contains ulipristal acetate as a single dose of 30mg. However, the MHRA states there have been no cases of serious liver injury with ellaOne® since it was launched in the EU in 2009, and there are no concerns or changes to its use at this time.

The MHRA alert announces new restrictions to the use of Esmya® following completion of a review by the European Medicines Agency (EMA) to investigate the link between Esmya® and cases of serious liver injury. The FSRH Clinical Effectiveness Unit (CEU) issued a clinical statement following the EMA review in February 2018 that led to temporary restrictions on the use of Esmya®.  

The new MHRA restrictions replace the EMA’s temporary safety measures. Rare but serious cases of liver injury, including cases of hepatic failure requiring liver transplantation, have been reported worldwide in women treated with Esmya®.  The EU review of the available data concluded that Esmya® may have contributed to the development of serious liver injury in some cases and a number of measures to minimise this risk have been put into place. In particular, more than one treatment course is now authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya®.

Where can you read about MHRA’s new restrictions?

You can read the MHRA letter for details of the restricted indication, new contraindication, and liver function monitoring requirements. Before initiating Esmya®, MHRA recommends discussing the rare risk of liver damage with patients and the need for liver function testing before, during, and after treatment courses. It also recommends advising women to seek urgent medical attention if they develop any symptoms or signs of liver injury, such as unusual tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting.

Healthcare professionals should also report any suspected adverse drug reaction to Esmya® through MHRA’s Yellow Card scheme without delay.

You can also read the safety alert issued by the Royal College of Obstetricians and Gynaecologists (RCOG) here.