Canada. Following consultation with Health Canada, all licensed providers of propofol are revising the Contraindication and Dosage and Administration sections of the product monograph for propofol. The revised monograph will include the following statement: ‘Propofol is contraindicated for sedation of children 18 years or younger receiving intensive care’. As of 10 July 2002, there were 6 reports of a constellation of serious adverse events characterized by metabolic acidosis, hemodynamic instability and cardiac conduction abnormalities in children receiving propofol infusions in an ICU setting in Canada. Three of these reports had a fatal outcome.
Readers are referred to an earlier ‘Dear Healthcare Professional’ letter issued by AstraZeneca in consultation with US FDA (WHO Pharmaceuticals Newsletter Nos. 2 & 3, 2001) emphasising that propofol (Diprivan) is not indicated for sedation in paediatric patients. The US FDA had determined that important safety concerns exist for propofol as a sedative in paediatric patients in intensive care.
Reports in WHO-file: Acidosis 85
1. Important Drug Safety
Information from the Marketed Health Products and Therapeutic Products Directorates, Health Canada, 10 Jul 2002. Available from URL: http://www.hc-sc.gc.ca
2. WHO Pharmaceuticals Newsletter Nos. 2 & 3, 2001. Available from URL: http://www.who.int/medicines/ organization/qsm/activities/drug safety/orgpharmanews.shtml