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Direct Healthcare Professional Communication (DHPC) on Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm
2022.07.01
Active substance: Hydroxyethyl starch, HES
Germany will suspend the authorisations by November 24, 2023
Despite restrictions for the use of HES solutions for infusion in 2013 and implementation of further extensive measures in 2018 to protect vulnerable patient populations, final results of a drug utilisation study have shown continued high non-adherence to the product information including non-adherence to contraindications. As a consequence, HES solutions for infusion have now been suspended from the EU market. Germany will defer the suspension for a period of 18 months. Thus, the date of suspension will be November 24, 2023.
It is emphasized again that it is of utmost importance that HES-containing infusion solutions are used exclusively in the authorized indications and in accordance with the contents of the mandatory training courses.
To the risk assessment procedure:
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN