Other safety alerts
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| European Union: EMA starts new review of hydroxyethyl-starch containing medicines. Studies show low adherence to restrictions aimed at reducing risks of kidney injury and death |
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The European Medicines Agency (EMA) of European Union (EU) has started a new review of medicines containing hydroxyethyl-starch (HES). These products are used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusion solutions known as ‘crystalloids’ alone is not considered to be sufficient. HES medicines are given by infusion (drip) into a vein and are used as blood volume expanders to prevent shock following acute bleeding.
The review is triggered by results from two drug utilisation studies indicating that HES-containing medicines were being used outside their authorised uses, including in critically ill patients and those with sepsis and kidney injury despite restrictions introduced in 2013 to reduce the risks of kidney problems and deaths.
The drug utilisation studies had been requested by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in 2013 as a condition to the marketing authorisations of these products, in order to verify adherence to the new restrictions.
PRAC will review the results of these studies, and all other available data, and their impact on the benefit-risk balance of HES-containing medicines for infusion and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002836.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 6 registered pharmaceutical products containing hydroxyethyl starch, namely Voluven Infusion 6% (HK-50474) and Volulyte 6% Solution for Infusion (HK-58087) registered by Fresenius Kabi Hong Kong Ltd; Tetraspan 6% Solution for Infusion (HK-56978) and Tetraspan 10% Solution for Infusion (HK-56979) registered by B. Braun Medical (HK) Ltd; and Hestar-200 Inj. 10% (HK-57095) and Hestar-200 Inj. 6% (HK-57096) registered by Unico & Co. Related news on increased risks of death and kidney injury in critically ill patients was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since June 2013, with the last update posted on 10 June 2016. Letters to local healthcare professionals to draw their attention on the above risks was issued on 17 June 2013. In December 2013, the Registration Committee of the Pharmacy and Poisons Board (the Registration Committee) decided that the package inserts of the above products should be updated to contain the information endorsed by the EMA's Coordination Group for Mutual Recognition and Decentralised Procedures – Human and PRAC, i.e. hydroxyethyl-starch solutions should no longer be used in patients with sepsis or burn injuries or in critically ill patients, and are contraindicated in sepsis, renal impairment or renal replacement therapy and critically ill patients. So far, DH has not received any adverse drug reaction case related to hydroxyethyl starch. DH will continue to remain vigilant on the safety of hydroxyethyl starch solutions.
Ends/Monday, October 30, 2017
Issued at HKT 17:45
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