European Union: PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids - Regular liver function testing required during treatment (English Only)
 
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Esmya (ulipristal acetate), following reports of serious liver injury. After considering all the evidence, the PRAC concluded that the medicine must not be used in women with liver problems and that certain other patients may start new treatment courses provided they have regular liver tests. 

Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb). The medicine has been shown to be effective at reducing bleeding and anaemia, as well as the size of the fibroids. 

The PRAC has concluded that Esmya may have contributed to the development of some cases of serious liver injury. The Committee has therefore made the following recommendations to minimise this risk: 

- Esmya must not be used in women with known liver problems. 
- A liver function test should be performed before starting each treatment course and treatment must not be started if liver enzyme levels are more than 2 times the upper limit of normal. 
- Liver function tests should be performed once a month during the first two treatment courses and two to four weeks after stopping treatment. If the test is abnormal (liver enzyme levels more than 3 times the upper limit of normal), the doctor should stop treatment and closely monitor the patient. 
- Esmya should be used for more than one treatment course only in women who are not eligible for surgery. Women who are about to have surgery should continue to use only one course. 
- A card will be included in the box of the medicine to inform patients about the need for liver monitoring, and to contact their doctor should they develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting). 
- Studies should be performed to determine the effects of Esmya on the liver and whether these measures are effectively minimising the risks. 

In February 2018, while the review was ongoing, the PRAC had issued temporary recommendations that no new patients should be started on Esmya. Having finalised its review, the Committee has now concluded that new patients can start treatment in line with the above recommendations to minimise the risk of liver injury. 

Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002957.jsp&mid=WC0b01ac058004d5c1 

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. 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 14 Apr 2018. Letter to inform local healthcare professionals was issued by the Department of Health (DH) on 12 Feb 2018. So far, DH has not received any case of adverse drug reaction related to ulipristal acetate for uterine fibroids. As the review of the drug by Health Canada is ongoing, and the EMA’s final recommendation is awaiting, DH will remain vigilant on the conclusion of these review and recommendation, and safety update of the drug issued by other overseas drug regulatory authorities. 

Ends/ Saturday, May 19, 2018 
Issued at HKT 12:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/ 
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