The European Medicines Agency (EMA) announces that the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) adopted Pharmacovigilance Risk Assessment Committee’s (PRAC) recommendation of suspending the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union.
On 11 February 2022, EMA’s safety committee, PRAC, recommended that the marketing authorisations for HES solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
The safety of HES solutions for infusion was reviewed by EMA in 2013, and a number of restrictions and measures to minimise the risk of kidney injury and death in certain patients (those critically ill, with burn injuries or with sepsis, a bacterial infection in the blood) were put in place at the time.
As a result of a review conducted in 2018, the use of HES solutions for infusion was further restricted to accredited hospitals, and healthcare professionals prescribing or administering the medicines had to be trained in their appropriate use. Additionally, further warnings were introduced in the product information to remind healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in other vulnerable patients such as the critically ill. These measures were put in place to ensure that HES solutions for infusion were not used in patients who were at increased risk of harm. Companies marketing HES solutions for infusion were also requested to conduct a drug utilisation study to check whether these restrictions were adhered to in clinical practice, and to submit the results of this study to EMA.
The PRAC reviewed the results from this study, which show that HES solutions for infusion are still being used outside the recommendations included in the product information. The Committee concluded that the further restrictions introduced in 2018 have not sufficiently ensured that the medicines are used safely, and that HES solutions continue to be used in certain groups of patients in whom serious harm has been demonstrated.
Since adherence to the set of measures agreed in 2018 was a condition for the safe use of HES solutions for infusion, and the study has shown this has not happened, the benefits of these medicines are no longer considered to outweigh their risks. The PRAC explored the possibility of introducing additional measures to ensure HES solutions are used according to the product information but concluded that there were no other measures, or combination of measures, that would be feasible and sufficient to protect patients.
In view of the serious risks that certain patient populations are still exposed to, the PRAC therefore recommended the suspension of the marketing authorisations for HES solutions for infusion in the European Union.
The PRAC recommendation was sent to the CMDh, which adopted its position on 23 February 2022. As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will take an EU-wide legally binding decision in due course.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/hydroxyethyl-starch-solutions-infusion-recommended-suspension-market
In Hong Kong, there are 4 registered pharmaceutical products containing hydroxyethyl starch, namely Voluven Infusion 6% (HK-50474) and Volulyte 6% Solution for Infusion (HK-58087) which are registered by Fresenius Kabi Hong Kong Limited; and Tetraspan 6% Solution for Infusion (HK-56978) and Tetraspan 10% Solution for Infusion (HK-56979) which are registered by B. Braun Medical (HK) Ltd. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to hydroxyethyl starch.
Related news on the increased risks of kidney injury and death associated with the use of hydroxyethyl starch was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 15 Jun 2013, with the last update posted on 12 Feb 2022. Letters to inform local healthcare professionals were issued by the DH on 17 Jun 2013 and 15 Jan 2018.
In Dec 2013, the Registration Committee of the Pharmacy and Poisons Board decided that products containing hydroxyethyl starch should contain the relevant safety information (hydroxyethyl starch is contraindicated in sepsis, burns, renal impairment or renal replacement therapy, critically ill patients, etc., and in patients undergoing open heart surgery in association with cardiopulmonary bypass the use of hydroxyethyl starch is not recommended due to the risk of excess bleeding).
As previously reported, the DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary. The information will be provided to the Registration Committee of the Pharmacy and Poisons Board for further consideration in view of latest recommendation issued by EMA.
Ends/Saturday, Feb 26, 2022
Issued at HKT 12:15
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