Other safety alerts
|
| |
| European Union: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing. No new patients should start treatment for the time being. |
| |
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya (ulipristal acetate), following reports of serious liver injury, including liver failure leading to transplantation.
As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids. All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment.
The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.
A link between Esmya and cases of serious liver injury is under review. These recommendations are temporary measures to protect patients’ health, pending the conclusion of the review of Esmya which started in Dec 2017.
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 pharmaceutical product registered by Orient Europharma Co. Ltd., and is a prescription-only medicine. Related news was previously issued by EMA, and was posted on the Drug Office website on 2 Dec 2017. So far, DH has not received any case of adverse drug reaction related to Esmya. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued. As the review of Esmya 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/Saturday, Feb 10, 2018
Issued at HKT 14:00
|
| |
|
