Other safety alerts
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| Singapore: PRECEDEX (dexmedetomidine): Increased risk of mortality in critically ill adult intensive care unit patients aged 63.7 years and younger and updates to the Singapore package insert |
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Health Sciences Authority (HSA) announces that 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 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 following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/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
In Hong Kong, there are 6 registered pharmaceutical products containing dexmedetomidine. All products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to dexmedetomidine, but this case was not related to death. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 12 Mar 2022. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Tuesday, Apr 4, 2023
Issued at HKT 15:00
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