Other safety alerts
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| European Union: Dexmedetomidine: increased risk of mortality in intensive care unit patients aged 65 years and less |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) discussed a direct healthcare professional communication (DHPC) containing important safety information for dexmedetomidine.
This DHPC aims to inform healthcare professionals of the increased risk of mortality when administering dexmedetomidine in intensive care unit (ICU) patients aged 65 years and less, compared with alternative sedatives.
SPICE III study was a randomised clinical trial comparing the effect of sedation with dexmedetomidine on all-cause mortality (deaths from any cause) with the effect of usual standard of care in 3,904 critically ill adult ICU patients in need of mechanical ventilation. The study showed no difference in the overall 90-day mortality between dexmedetomidine and alternative sedatives (propofol, midazolam). However, dexmedetomidine was associated with an increased risk of mortality in patients aged 65 years and less, compared with alternative sedatives.
The product information for dexmedetomidine is being updated with a warning describing the evidence and risk factors. Healthcare professionals are being advised to weigh these findings against the expected clinical benefit of dexmedetomidine compared to alternative sedatives in this age group.
The DHPC for dexmedetomidine will be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in European Union Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-march-2022
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. The DH will remain vigilant on any safety updates issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, Mar 12, 2022
Issued at HKT 12:00
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