Inpharma 1305 - 15 Sep 2001

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Propofol contraindicated in patients aged ≤ 16 years in UK After reviewing all available data on the use of IV propofol [‘Diprivan’] in patients aged ≤ 16 years, the UK CSM* has advised that propofol should be contraindicated in this age group, reports the UK MCA.** The product information for propofol is being revised to reflect this contraindication. The MCA notes that, in 1992, it was reported that children who had received infusions of propofol for sedation developed metabolic acidosis, hyperlipidaemia and hepatomegaly; in some cases the children died as a result of the complication. At that time, the CSM issued a warning against such use. Moreover, the MCA reports unpublished data from a recent trial in which 327 paediatric patients received propofol 1 or 2%, or other sedative agents. The death rates during the study, and 28 days of follow-up, were 8 and 11% for patients who received propofol 1 and 2%, respectively, compared with 4% for the control group. Furthermore, patients who received propofol at either strength experienced significantly more adverse reactions overall, and serious adverse reactions, than those in the control group. * Committee on Safety of Medicines ** Medicines Control Agency Propofol (Diprivan) infusion: sedation in children aged 16 years or younger contraindicated. Current Problems in Pharmacovigilance 27: 10, Aug 800863390 2001

» Editorial comment: Earlier this year, AstraZeneca in the US issued a ‘Dear Health Care Provider’ letter advising that propofol should not be used for sedation in paediatric patients [see Inpharma 1286: 20, 5 May 2001; 800863322].

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Inpharma 15 Sep 2001 No. 1305