Other safety alerts
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| European Union: Esmya: new measures to minimise risk of rare but serious liver injury -EMA concludes review of medicine for uterine fibroids |
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The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate). Certain women may start treatment with Esmya once the new measures are implemented.
The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury. In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.
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 associated with the condition, as well as the size of the fibroids.
The review of Esmya was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation. The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.
The PRAC therefore recommended that use of the medicine should be restricted. It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.
The PRAC’s recommendations have now been endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision. A letter will be sent to doctors to inform them of the new conditions of use, which will become applicable after a Commission decision is issued.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002966.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 19 May 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 are ongoing, DH will remain vigilant on the conclusion of these reviews and safety update of the drug issued by other overseas drug regulatory authorities.
Ends/ Saturday, Jun 2, 2018
Issued at HKT 12:00
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