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CMAJ • March 18, 2003; 168 (6)
© 2003 Canadian Medical Association or its licensors

Letters
Correspondance

Propofol syndrome in children

Eric Wooltorton

CMAJ

My article on propofol1 highlighted the roles of CMAJ's Health and Drug Alerts column: to emphasize warnings from recent international "Dear Healthcare Professional" letters, to distill key messages when such letters are vague and to bring debates from more specialized bodies of literature to our general medical audience. Questions about the exact frequency and risk factors for a so-called propofol syndrome in critically ill children are certainly worthy of future systematic and rigorous research. However, I believe the real issue is not whether the syndrome truly exists, but whether a single advisory from the US Food and Drug Administration (FDA) in 2001 is sufficient to put the issue to rest. We know from the cisapride story that even multiple warnings can fail to have an impact on physicians' prescribing behaviours.2,3 In the case of propofol, postmarketing adverse events (including deaths) continued to occur in Canada, despite the 2001 FDA warning, and were the reason that Health Canada issued its own warning.4 I felt it wise to echo these concerns, to frame the debate for those who were unfamiliar with it and to recommend that patients be kept informed.

I can appreciate the letter writers' concerns about whether or not to include "theoretical risks" in preoperative discussions with patients and their families. Although I usually choose to inform patients of all serious adverse events (including those that are rare), I admit that in writing this column I should have better emphasized the difference between concerns about propofol's use for the long-term sedation of critically ill pediatric patients and its relative safety in other contexts.

Eric Wooltorton CMAJ

References

  1. Wooltorton E. Propofol: contraindicated for sedation of pediatric intensive care patients. CMAJ 2002; 167(5):507.[Free Full Text]
  2. Sibbald B. Cisapride, before and after: still waiting for ADE-reporting reform. CMAJ 2001;165 (10): 1370. [Free Full Text]
  3. Postmarketing drug surveillance: what it would take to make it work [editorial]. CMAJ 2001;165 (10): 1293. [Free Full Text]
  4. Propofol contraindicated for sedation in pediatric patients receiving intensive care. Ottawa: Health Canada; 2002 Jul 10. Available: www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/advisory/tpd/propofol_pediatric2_e.html (accessed 2003 Feb 13).




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