CMAJ • May 29, 2001; 164 (11)
© 2001 Canadian Medical Association or its licensors
FDA issues warning on propofol (Diprivan)
The US Food and Drug Administration (FDA) has issued a warning against the off-label use of the injectable sedative propofol in pediatric patients in intensive care units (www.fda.gov/medwatch/safety/2001/safety01.htm#dipriv).
Propofol is used for induction and maintenance of anesthesia. Because it allows easy arousability and recovery shortly after the infusion stops, it is also used in intensive care units, emergency rooms and other areas during minor procedures, intubation and artificial ventilation. Although general anesthesia is the only approved pediatric use for the drug, its attractive characteristics have led to its use in children in intensive and emergency care settings. The FDA became concerned after reviewing data from a randomized, controlled clinical trial of the safety and effectiveness of propofol vs. standard sedative agents in pediatric ICUs. About 10% of children who received propofol died, compared with only 4% of children receiving standard sedating agents. Further trials are under way. CMAJ is committed to releasing FDA and Health Canada drug warnings as soon as they are available (CMAJ 2001;164[9]:1269).
