The Medicines and Healthcare products Regulatory Agency (MHRA) announces that temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.
An EU-wide review of Esmya started in December 2017 following reports of serious liver injury in women using the medicine. The review is ongoing; however, temporary safety measures were introduced in February 2018 to protect women’s health pending finalisation of the investigation. These measures were considered necessary following receipt of the fifth case of hepatic failure (the fourth that required liver transplantation). The MHRA will provide further information as soon as the EU review is completed. Further information about the review can be found on the website of the European Medicines Agency (EMA).
Healthcare professionals were informed of the temporary safety measures by the MHRA through a notice on the Central Alerting System and the Marketing Authorisation Holder has sent a letter to prescribers in the UK. The EMA has issued information to both healthcare professionals and women, available on their website.
To date, the MHRA has received 1 suspected adverse drug reaction report of hepatitis with the use of Esmya in the UK. Approximately 20,400 treatment courses of Esmya were dispensed in the UK between 1 October 2016 and 30 September 2017.
The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.
Advice for healthcare professionals:
- do not initiate new treatment courses of Esmya, 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 and again 2–4 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 (for example nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia, or jaundice)
- stop Esmya in any woman who develops transaminase levels more than 2-times the upper limit of normal, closely monitor and refer women for specialist hepatology evaluation as clinically indicated
- advise women using Esmya about the signs and symptoms of liver injury and tell them to seek immediate medical attention if they occur
- report suspected adverse drug reactions without delay
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/esmya-ulipristal-acetate-for-uterine-fibroids-do-not-initiate-or-re-start-treatment-monitor-liver-function-in-current-and-recent-users
In Hong Kong, Esmya Tablets 5mg (HK-62553) is a pharmaceutical product registered by Orient Europharma Co. Ltd., and is a prescription-only medicine. Related news was previously issued by the EMA, the MHRA and Singapore Health Sciences Authority, and was posted on the Drug Office website on 2 December 2017, 10 February 2018, 20 February 2018 and 21 February 2018. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 12 February 2018. So far, DH has not received any case of adverse drug reaction related to Esmya. As the review of Esmya by the EMA is ongoing, DH will remain vigilant on the conclusion of the review and safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, March 9, 2018
Issued at HKT 17:00
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