PRECEDEX–Increased risk of mortality in critically ill adult intensive care unit patients aged 63.7 years & younger and updates to the Singapore package insert

A Dear Healthcare Professional Letter has been issued by Pfizer Private Limited to inform healthcare professionals of an increased risk of mortality in critically ill adult intensive care unit (ICU) patients aged 63.7 years and younger associated with the use of dexmedetomidine for more than 24 hours. This finding was from The Sedation Practice in Intensive Care Evaluation (SPICE) III randomised controlled trial that investigated the use of dexmedetomidine as a primary sedative compared with usual care in 3,904 critically ill adult ICU patients. In the study, the exposure to dexmedetomidine was greater than 24 hours with a median duration of treatment of 2.56 days (interquartile range, 1.10 to 5.23) and administration of dexmedetomidine was continued as clinically required for up to 28 days after randomisation. The Singapore package insert (PI) for PRECEDEX has been updated to reflect this new safety concern. It has also been revised to include warnings on hyperthermia/pyrexia and updated information on use in pregnancy and lactation. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.