Safety studies are urgently needed for the newer anti-epilepsy drugs
that are increasingly being prescribed for children, say UK
The British Journal of Clinical Pharmacology
report that prescriptions have risen five-fold in 13 years. But the
researchers say the drugs' long-term safety has not been established.
medicines are not fully tested on children before licensing, so
consultants have no official guidance on dosage to refer to when
prescribing. Instead they often have to estimate a safe and effective
dose based on the age and the size of the child.
Lead author Professor Ian Wong, from the Centre for Paediatric Pharmacy Research
in London, studied anti-epileptic drugs given to nearly 8,000 children
over a 13-year period. He and his colleagues found three drugs in
particular -- lamotrigine, topiramate and levetiracetam - had seen a
"massive" rise in prescribing.
"The uptake of these
drugs has been rapid, yet their long-term safety has not been
established and further research must now be seen as a priority," he
He added that while newer drugs were less likely to
react with other prescribed drugs, it was possible that restrictions in
their use might have to be introduced as any side-effects in children
became more apparent. He said multi-organ failure, renal failure, blood
disorders and skin reactions had been reported in patients using
Dr Colin Ferrie, a consultant paediatric
neurologist at Leeds General Infirmary, said that not only were new
trials important, but pharmaceutical companies should be encouraged to
carry out "clinically relevant" trials prior to the original granting
of a licence.
"Obviously it's an area of concern, and when
you are prescribing a drug 'off licence' to a child, it's important to
let the family know exactly the implications of this. "However, it is
often possible to find data, either from journal abstracts or the drug
company, which can help you calcula