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The Pharmaceutical Journal
Increase in fatal ADRs in children
Anticonvulsants are associated with most of the suspected fatal adverse drug reactions (ADRs) in children reported through the Medicines Control Agency yellow card scheme, British researchers say.
They examined all ADRs with a suspected fatal outcome that were reported through the scheme between 1964 and December 2000, excluding vaccines and overdoses. In all, there were 43,755 ADRs, 331 of which had a fatal outcome (Archives of Disease in Childhood 2002;87:462).
Anticonvulsants were associated with 65 of these deaths, particularly sodium valproate, which was mentioned in almost half of cases (31). The newer anticonvulsants, such as vigabatrin (Sabril) and lamotrigine (Lamictal), were associated with 20 deaths, cytotoxic drugs with 34 and antibiotics with 29. Liver failure was the most commonly noted ADR with a fatal outcome in 50 of the 331 cases.
The researchers found that the number of overall adverse drug reaction and deaths reported in the past 10 years had increased compared with previous decades. There were 28,197 ADRs and 151 associated deaths from 1991?2000, compared with 10,562 ADRs and 92 deaths from 1981?90, and 4,601 ADRs and 64 deaths from 1971?80. However, they warn that the number of deaths is likely to be an underestimate, since ADRs are known to be under-reported.
The researchers also point out that the yellow card scheme only detects signals of drug safety and does not assess causality, which can only be determined properly through prospective studies. They conclude that the overall benefit of medication to children is likely to be far greater than the risk, but that doctors need to be more aware of guidelines that recommend avoiding medicines in certain high-risk groups.
"The use of propofol in the critically ill child and sodium valproate in young children under the age of three years, with developmental delay or polypharmacy, are examples where we hope further deaths might be avoided," they say.
In an accompanying editorial (ibid, p466), Dr Harvey Marcovitch, editor of Archives of Disease in Childhood, stresses that parents need not be alarmed by the study findings, and reiterates that causality has not been proven. But he agrees more research is needed: "We echo [the researchers'] call for more risk-benefit analyses of medicines used by children, particularly newer anticonvulsants."
Citation: The Pharmaceutical Journal URI: 20008275
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