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Propofol- Notice to Hospitals from the Therapeutic Products Directorate
Date: 2001-02-13
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Therapeutic Products Directorate (TPD) posts safety alerts, public health advisories, press releases and other notices as a service to healthcare professionals, consumers, and other interested parties. Although TPD approves therapeutic products, TPD does not endorse either the product or the company. Any questions regarding product information should be discussed with your healthcare professional.
NOTICE TO HOSPITALS
from the Therapeutic Products Directorate
Long- term propofol infusions, metabolic acidosis, rhabdomyolysis and cardiac failure
February 13, 2001
To: Hospital Chief of Medical Staff
Please forward the following information to involved Departments such as Pharmacy, Intensive Care Units (ICUs) and Anaesthesiology.
Therapeutic Products Directorate (TPD) wishes to draw your attention to several recent publications identifying an association in adults between high infusion rates (greater than 5 mg/kg/h) of propofol for more than 48 hours in ICUs and a potentially fatal constellation of adverse events characterized by metabolic acidosis, rhabdomyolysis and cardiovascular collapse 2, 3, 4. Similar findings were first reported in the literature in 1992 in children who received high doses of propofol in the ICU1.
The majority of the above-reported cases occurred in adults with head injury. These patients were treated with propofol at infusion rates greater than 5 mg/kg/h in an attempt to control intracranial hypertension 2, 3, 4. It is unclear at this time whether propofol at these high infusion rates can provide enhanced intra cranial pressure reduction. A causal relationship between these adverse events and propofol and/or the lipid carrier cannot yet be established 2, 3, 4.
You are referred to the Product Monograph for 1% w/v Propofol injection 10 mg/mL for recommendations regarding the use of propofol in ICU sedation.
References:
1 Parke, T. J. et al. (1992) British Medical Journal 305:613-616
2 Perrier, N.D. et al.(2000) Critical Care Medicine 28:3071-3074
3 Stelow, E.B. et al. (2000) Clinical Chemistry 46(4): 577-581
4 Cremer,O.L. et al. (2001) Lancet 357:117-118.
Questions regarding this message can be directed to the Central Nervous System Unit, Bureau of Pharmaceutical Assessment, Therapeutic Products Directorate at (613) 941-3181.
Any suspected adverse drug reactions can be reported to:
Canadian Adverse Reaction Monitoring Program (CADRMP)
Bureau of Licensed Product Assessment
Therapeutic Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
cadrmp@hc-sc.gc.ca
The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceutical and Specialties, or on the TPD website, along with the ADR Guidelines.
