Health Sciences Authority (HSA) would like to bring to the attention of healthcare professionals the risk of serious liver injury associated with the use of Esmya (ulipristal acetate 5mg). Overseas cases of serious liver injury have been reported in women who had received treatment with Esmya, including four cases which required liver transplantation. At this time, this safety concern has not been observed with another registered product containing the same active ingredient (Ella, ulipristal acetate 30mg) used for emergency contraception.
From Feb 2012 to Feb 2018, 105 post-marketing cases of hepatic disorders have been reported overseas with the use of Esmya, of which 34 cases were assessed to be serious. Esmya was considered as a potential contributing factor for causing liver injury in eight of the serious cases, including four cases of acute liver failure leading to liver transplantation. A contributing role of Esmya in the development of acute liver failure in two of the cases was assessed to be probable, while insufficient information was available to either conclude or rule out a causal relationship with Esmya for the remaining two cases. For the other four serious cases of liver injury, although a causal role of Esmya was considered possible, available information was insufficient to draw firm conclusions on causality. The possible causal associations for these cases were mainly supported by positive de-challenge, absence of other confounding factors, or explanations for the observed liver injury.
At this time, the mechanism by which Esmya could potentially cause liver injury remains uncertain, and no clear pattern in the timing between Esmya treatment and the occurrence of liver injury has been identified.
As of Jun 2019, HSA has received two non-serious local adverse event reports of elevations in liver function tests that were assessed to be possibly related to treatment with Esmya. In both cases, the increase in liver enzymes were less than three times the upper limit of normal, and were observed approximately two weeks or three months after the initiation of treatment with Esmya. Treatment discontinuation was reported in one case, with a subsequent decrease in the patient’s liver enzymes approximately one month later.
HSA has reviewed the available information on liver injury associated with Esmya and assessments conducted by other regulatory agencies. HSA took into consideration its local adverse event reports, expert opinions from local clinicians and the company-initiated amendments to the local Esmya package insert (PI). To mitigate the risk of serious liver injury associated with the use of Esmya, the company will be strengthening the local PI of Esmya to contraindicate its use in patients with underlying liver disorders, as well as recommend more stringent criteria for liver function monitoring. The indications for Esmya will also be revised to clarify its use as a single treatment course when used in the pre-operative setting, and to restrict its use to adult women of reproductive age not eligible for surgery when used for the intermittent treatment of moderate to severe symptoms of uterine fibroids. In addition, the compnay has developed a patient information brochure, for distribution to patients through their healthcare professionals, to inform patients about the potential risk and the signs and symptoms of liver injury to look out for during treatment with Esmya. This brochure has been reviewed and approved by HSA.
Healthcare professionals are advised to take into consideration the above safety information when prescribing Esmya. They may wish to consider using the patient information brochure to counsel patients treated with Esmya on the need to monitor for signs and symptoms of liver injury (e.g. yellowing of the skin, fatigue or excessive tiredness, nausea and vomiting) during and after treatment. Healthcare professionals are also encouraged to report to HSA any suspected cases of liver injury related to the use of Esmya.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../risk-of-serious-liverinjurywithesmyaulipristalacetate.html
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 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 4 Apr 2019. Letters to inform local healthcare professionals of the risk of serious liver injury were issued by the DH on 12 Feb 2018. On 12 Dec 2018, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the relevant warnings should be included in the package insert of the product. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Friday, Sep 13, 2019
Issued at HKT 15:00
|
