其 他 安 全 警 示
|
| |
| European Union: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market (English only) |
| |
The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union (EU). These products were authorised as an addition to other treatments for plasma volume replacements following acute (sudden) blood loss.
The safety of HES solutions for infusion was reviewed in two separate procedures 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, i.e. a bacterial infection in the blood) were put in place at the time.
As a result of a third 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. Companies marketing HES solutions for infusion were also requested to conduct a drug utilisation study to check that the restrictions were adhered to in clinical practice, and to submit the results of this study to EMA.
The PRAC has now 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. In view of the serious risks that certain patient populations are still exposed to, the PRAC has therefore recommended the suspension of the marketing authorisations for HES solutions for infusion in the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-february-2022
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 8 Jul 2021. 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).
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.
Ends/ Saturday, Feb 12, 2022
Issued at HKT 12:00
|
| |
|
