BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Dear Doctor Letter (Rote-Hand-Brief) on hydroxyethyl starch (HES) solutions for infusion: new measures to reinforce existing restrictions due to increased risk of renal dysfunction and mortality in critically ill or septic patients

Active substance: hydroxyethyl stark, HES

The marketing authorisation holders inform that hydroxyethyl starch (HES)-containing solutions for infusion have continued to be used in patients with contraindications. Such contraindicated use is associated with a risk for serious harm, including increased mortality.

A new programme for controlled access of hydroxyethyl starch (HES) containing medicines for infusion will be implemented.

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Hydroxyethyl starch (HES) containing medicinal products

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 231KB, File is accessible

Use of cookies

Cookies help us to provide our services. By using our website you agree that we can use cookies. Read more about our Privacy Policy and visit the following link: Privacy Policy (only in German)

OK