HES will be available in restricted patient populations
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), has endorsed by majority the recommendations of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
The CMDh also agreed with the PRAC recommendation that HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as ‘crystalloids’ alone are not considered to be sufficient. In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients’ kidney function should be monitored after HES administration. In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.
The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
As the CMDh position has been adopted by majority vote, it will now be sent to the European Commission, which will take a final legally binding decision that will be valid throughout the European Union (EU).
Please refer to the following website at EMA for details :
http://www.ema.europa.eu/../news_detail_001930.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 6 registered pharmaceutical products containing hydroxyethyl starch, namely Voluven Infusion 6% (HK-50474), Volulyte 6% Solution for Infusion (HK-58087), Tetraspan 6% Solution for Infusion (HK-56978), Tetraspan 10% Solution for Infusion (HK-56979), Hestar-200 Inj. 10% (HK-57095) and Hestar-200 Inj. 6% (HK-57096). The Drug Office of Department of Health has contacted the registration certificate holders of the above products for updates and details of the situation. Only 2 products, Voluven Infusion 6% and Volulyte 6% Solution for Infusion, registered by Fresenius Kabi Hong Kong Ltd are marketed in Hong Kong. Related news has been released by EMA, FDA, Health Canada, MHRA and TGA, and was posted on the Drug Office website on 15 June, 25 June, 28 June, 10 July, 19 July and 12 Oct 2013 respectively. A letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 17 June 2013. The Registration Committee of the Pharmacy and Poisons Board discussed the matter in the meeting in July 2013 and, based on the available evidences, concluded that Drug Office will remain vigilant on any further new safety updates of hydroxyethyl starch released by overseas regulatory authorities for further consideration by the Registration Committee. As reported on 12 Oct 2013, the information will be provided to the Registration Committee for further consideration in view of latest recommendation issued by EMA.
Ends/ Saturday, Oct 26, 2013
Issued at HKT 12:00
|
