Other safety alerts
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| European Union : EMA starts review of Esmya for uterine fibroids - Review triggered by cases of liver injury |
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The European Medicines Agency (EMA) has started a review of the medicine Esmya (ulipristal acetate) used to treat uterine fibroids (non-cancerous tumours of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with the medicine.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has made an initial assessment of the cases of liver injury and considered that Esmya could be the cause.
Given the seriousness of the observed liver injury and its possible link to the medicine, a more in depth review is warranted.
The PRAC will now evaluate all available data and determine whether there are any implications for the use of Esmya.
While the review is ongoing, patients should contact their doctor if they have any questions or concerns about their treatment.
Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne. No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000070.jsp&mid=WC0b01ac05805c516f
In Hong Kong, Esmya Tablets 5mg (HK- 62553) is a pharmaceutial product registered by Orient Europharma Co. Ltd. and is a prescription only medicine. So far, DH has not received any case of adverse drug reaction related to Esmya. In view of the EU PRAC’s review is ongoing, DH will keep vigilant on the result and against any safety updates of the drug.
Ends/Saturday, December 2, 2017
Issued at HKT 13:00
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