Direct Healthcare Professional Communication (DHPC) on dexmedetomidine: risk of increased mortality in intensive care patients ≤ 65 years of age
2022.06.15
Active substance: dexmedetomidine
The marketing authorisation holders of dexmedetomidine-containing medicinal products, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), inform about the results from the SPICE III study - a randomised clinical trial comparing the effect of sedation with dexmedetomidine on all-cause mortality with the effect of "usual standard treatment" in 3904 ventilated, critically ill adult patients in intensive care. The use of dexmedetomidine was associated with a higher risk of mortality compared to other sedatives in the age group ≤ 65 years.
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