Surveillance for fatal suspected adverse drug reactions in the UK.
OBJECTIVE
To determine the nature and number of suspected adverse drug reactions (ADRs) associated with fatal outcomes in children reported through the yellow card scheme.


METHODS
All reports of suspected ADRs with a fatal outcome in children received by the UK Committee on Safety of Medicines through its Yellow Card Scheme from 1964 until December 2000 were reviewed. Reports associated with vaccines and overdose were excluded. The medicine, date of the report, diagnosis, ADR, and the age of the child were analysed. No formal causality assessment was performed.


RESULTS
There were 331 deaths with 390 suspected medicines reported for children aged 16 years or less. Medicines most frequently mentioned were anticonvulsants (65 deaths), cytotoxics (34 deaths), anaesthetic agents (30 deaths), and antibiotics (29 deaths). The individual drug most frequently mentioned was sodium valproate (31 deaths). The nature of the reported ADRs were diverse, with hepatic failure the most frequent. In the past decade, there has been an increase in both the total number of suspected ADRs reported in children and the number of reports with a fatal outcome.


CONCLUSIONS
A wide range of suspected ADRs are associated with fatalities in children. Anticonvulsants were associated with the greatest number of reports of fatalities and hepatotoxicity in particular.
Clarkson
A
A
Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3NE, UK.
Choonara
I
I
D000777:Anesthetics / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D000927:Anticonvulsants / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D017093:Liver Failure / Q000139:chemically induced; D006113:United Kingdom / Q000453:epidemiology; D014635:Valproic Acid / Q000009:adverse effects
D000777:Anesthetics; D000900:Anti-Bacterial Agents; D000927:Anticonvulsants; D000970:Antineoplastic Agents; D014635:Valproic Acid