The changes to the product information for dexmedetomidina are a result of an assessment of a randomised clinical trial (SPICE III) comparing the effect of sedation with dexmedetomidine on all-cause mortality with the effect of “usual standard of care” in 3904 ventilated critically ill adult intensive care unit (ICU) patients.

Dexmedetomidine was associated with an increased risk of mortality in the age group ≤65 years compared with alternative sedatives. The product information of dexmedetomidina will be updated accordingly.