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Bruce C Carleton
M Anne Smith
Michaela N Gelin
Susan C Heathcote


Adverse drug reactions, adverse drug reaction voluntary reporting, paediatrics



Severe adverse drug reactions (ADRs) are an important cause of childhood morbidity and mortality. 95% of ADRs are likely not reported, less than 25% of marketed drugs can be advertised as safe and effective in children; yet over 50% of Canadian children receive prescription drugs annually.


To increase understanding of reported ADRs in Canadian children.


A retrospective analysis of 1193 suspected ADRs reported to Health Canada (January 1998 - May 2002). These  data  were  a  paediatric  subset  of  the  Canadian  Adverse  Drug  Reaction  Information  System database.


58.6% of ADRs were for children over 13 years.   61% of reports were defined by Health Canada as serious. Case outcomes include: death (n=41) and recovered with sequelae (n=14). 4 reports of interacting drugs had fatal outcomes. Drugs most frequently cited include: isotretinoin (n=56), paroxetine (n=42), methylphenidate (n=41), amoxicillin (n=40), and valproic acid (n=32). Most frequent reaction descriptors include: psychiatric disorders (isotretinoin and paroxetine) and nervous system disorders (valproic acid, bupropion and carbamazepine). Causal links between suspected ADRs and clinical outcomes have not been established.


Current ADR reporting is insufficient to improve patient safety. More detailed reporting, including case outcomes, is needed. Mandatory ADR reporting is unlikely to improve underreporting. Trained surveillance personnel located in major health centres and solely dedicated to ADR reporting may provide a more accurate determination of ADRs in Canadian children

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