The Medicines and Healthcare products Regulatory Agency (MHRA) announces that, on 9 Mar 2020, the European Medicines Agency (EMA) started a review of Esmya following a new case of liver failure requiring liver transplant. This case occurred despite the patient and physician having adhered to measures that were put in place following a previous review to minimise the risk of liver injury, namely measuring liver function before and during treatment, and stopping treatment immediately in case of raised liver enzyme levels. This is now the fifth case of liver injury requiring liver transplant reported worldwide in women receiving Esmya.
To protect public health, marketing authorisations for all ulipristal acetate 5mg products for uterine fibroids will be suspended in the United Kingdom for the duration of the review. Patients currently taking Esmya for uterine fibroids should stop taking the medicine and no new patients should start treatment. The MHRA will communicate the recommendations of the review once finalised.
The MHRA has issued a recall of Esmya from pharmacies, wholesalers, and patients.
Since authorisation and to date, the MHRA has received 19 suspected adverse drug reaction reports of liver disorders with the use of Esmya in the United Kingdom. None report liver transplant or death. Approximately 2,865 treatment courses of Esmya were dispensed in the United Kingdom in 2019.
The emergency contraceptive ellaOne also contains ulipristal acetate (single dose, 30mg). There are no concerns with this medicine at this time.
Healthcare professionals are advised:
- Contact patients currently being treated with Esmya as soon as possible and stop their treatment; discuss alternative treatment options for uterine fibroids as appropriate.
- Do not start any new patients on Esmya.
- Advise recent users to seek immediate medical attention if they develop signs and symptoms of liver injury (nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia or jaundice).
- Perform liver function tests 2–4 weeks after stopping Esmya as recommended in the product information.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/esmya-ulipristal-acetate-suspension-of-the-licence-due-to-risk-of-serious-liver-injury
In Hong Kong, Esmya (ulipristal acetate) Tablets 5mg (HK-62553) is a pharmaceutical product registered by Orient Europharma Co. Ltd, and is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Esmya.
Related news on the previous review of Esmya was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2 Dec 2017, with the latest update posted on 13 Sep 2019. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. In Dec 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of the product should include the relevant safety information.
Related news on the recent review of Esmya was previously issued by the European Medicines Agency, and was posted on the Drug Office website on 14 Mar 2020. Letters to inform local healthcare professionals were issued by the DH on 16 Mar 2020. The DH will remain vigilant on the conclusion of the review and safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Mar 19, 2020
Issued at HKT 17:30
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