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Suspected fatal side effects of drugs in children have risen over past decade

November 25, 2002

The number of suspected fatal side effects from drugs prescribed to children and reported to the UK’s drugs early warning system, has risen over the past decade, shows research in the Archives of Disease in Childhood.

Anti-epileptic drugs were associated with the highest number of reported deaths, and in particular liver damage, the data show.

The authors assessed all suspected fatal drug side effects in children, and reported by doctors to the UK Medicines Control Agency (MCA) through its voluntary Yellow Card scheme between 1964 and 2000. Vaccines and overdoses were excluded. No attempt was made to formally assess the cause of a child’s death.

During that time, 331 children up to the age of 16 died and 390 suspect medicines were reported to the MCA. Certain drugs were mentioned more frequently in association with the deaths.

Anti-epileptic drugs were associated with 65 deaths, in almost half of which (31) sodium valproate was mentioned. The newer class of anticonvulsants, including vigabatrin and lamotrigine, were associated with 20 deaths. Cell killing drugs (cytotoxics) were associated with 34 deaths, anaesthetic agents with 30, and antibiotics with 29. The range of adverse effects reported varied widely, but liver failure was the most commonly noted.

Since 1964, Yellow Card reports for children have steadily increased, doubling between 1995 and 2000, although the proportion of deaths has fallen. But altogether, almost half of the 331 total deaths have occurred since 1991.

The authors note: “We believe that the 331 deaths reported as associated with [adverse drug reactions] is likely to be an underestimate, as it is well recognised that [these reactions] are significantly under reported.”

But they hasten to add: “Our study has not looked at evaluating the benefit of medicines, but for all the medicines studied, the overall benefit to children is likely to be far greater than the risk.”

An accompanying commentary by the journal’s editor, Dr Harvey Marcovitch, reiterates that this research does not prove that the drugs caused children to die, and says that parents should not be unduly alarmed for their children’s safety.

But Dr Marcovitch echoes the authors’ call for more analyses to work out the true risks and benefits of particular drugs used to treat children, particularly the newer class of anti-epileptic drugs. “The Yellow Card scheme is too blunt an instrument to tell us anything useful about causation or about balancing risks and benefits,” he concludes.

British Medical Journal (BMJ)

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