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Public release date: 7-Jun-2007
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Blackwell Publishing Ltd.
Experts call for urgent research into anti-epileptic drugs given to children
Study of 8,000 children found significant rise in prescribing of newer drugs
whose long-term safety has not been established
Researchers have called for urgent studies into the long-term safety of newer
antiepileptic drugs after discovering that the number given to children has
increased significantly over recent years, reports the June issue of British
Journal of Clinical Pharmacology.
When the UK team studied antiepileptic drugs (AEDs) given to nearly 8,000
children over a 13-year period, they discovered that overall prescribing had
risen by 19 per cent and there had been a five-fold increase in prescribing of
newer AEDs.
The results follow a report by the European Medicines Agency (EMEA) which called
for greater research into paediatric drugs for epilepsy.
"EMEA recommended further research into 21 antiepileptic drugs for children but
didn't indicate which ones should be prioritised" explains Professor Ian Wong
from the Centre for Paediatric Pharmacy Research, a collaborative project run by
the School of Pharmacy at the University of London, the UCL Institute of Child
Health and Great Ormond Street Hospital.
"Our research has narrowed that list down to three drugs that have seen a
massive rise in UK prescribing since 1993 - lamotrigine, topiramate and
levetiracetam. 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."
Worldwide concern has been expressed about the need to reform regulations and
develop better research structures for paediatric medicines, says Professor
Wong, who is also a member of TEDDY - the Task-force of European Drug
Development for the Young.
"The American Food and Drug Administration and the National Institutes of Health
have been leading the process for paediatric drug reform over the last ten
years. And the European Union has proposed the "Better Medicines for Children"
regulation and devised a research strategy to improve paediatric medicines
research in the hope of increasing the availability of licensed medicines for
children" he says.
Concerns over paediatric AEDs have risen in recent years after prescribing
restrictions were issued on vigabatrin in the late 1990s following reports that
one-third of users suffered from visual field defects, ranging from asymptomatic
to severe and potentially disabling.
In 2004, the National Institute for Health and Clinical Excellence - the UK
Government's advisory body on therapeutic interventions - stated that vigabatrin
should only be prescribed in cases of West's Syndrome (infantile spasms) and
then only by an epilepsy specialist, a neurologist or a paediatric neurologist.
Professor Wong and his research colleagues studied 7,721 patients from birth to
18, using data from the UK General Practice Research Database, analysing the
results by age and the AED prescribed.
Their findings included:
More than a quarter of a million prescriptions (257,663) were issued for AEDs
during the study period. Of these, 69 per cent were for conventional AEDs and 31
per cent were for newer AEDs.
The most commonly prescribed newer AED was lamotrigine, which accounted for 20
per cent of all prescriptions and 65 per cent of newer AED prescriptions.
Valproate was the most commonly prescribed conventional AED, accounting for 36
per cent of all prescriptions and 52 per cent of conventional AED prescriptions.
54 per cent of children receiving prescriptions were male and prescribing for
new patients was highest in the two to 11 age group (45 per cent) and the 12 to
18 age group (39 per cent). 16 per cent of prescriptions were for children under
two years of age.
70 per cent of children were receiving just one AED, which is consistent with
adult research, which suggests that 60 to 70 per cent of patients have their
epilepsy controlled by one AED.
"To our knowledge this is the first large paediatric study to compare newer and
conventional AED prescribing in the UK" says Professor Wong, who - as a result
of the study - has been awarded a research contract by the Medicine and
Healthcare products Regulatory Agency to assess deaths among children and
adolescents using antiepileptic drugs.
"Our research found that paediatric prescribing of antiepileptic drugs showed a
significant increase over the study period and that newer AEDs are increasingly
being prescribed in preference to more tried and tested conventional drugs.
"Newer AEDs have proved popular, mainly because they are less likely to react
with other prescribed drugs.
"However, these newer AEDs are subject to fewer licensing restrictions because
there is more evidence about their benefits, gathered from controlled trials,
than their more traditional counterparts. As new safety data emerges,
restrictions in prescribing may be implemented."
"Many drugs are not tested on children before they are licensed because of the
difficulties of including children in clinical trials" adds Dr Jeffrey Aronson,
Editor-in-Chief of the Journal and Reader in Clinical Pharmacology at Oxford
University.
"This means that clinicians often have to rely on their experience and scale
down adult drugs for paediatric use, which is widely regarded as most
unsatisfactory.
"The research by Wong and colleagues highlights this important problem, by
providing us with an excellent picture of prescribing trends for children with
epilepsy. We hope that this important piece of research will help to inform
research priorities for the newer AEDs.
"It also raises concerns about the rapid increase in prescribing drugs whose
safety has not been established for paediatric use, which is an issue that the
Journal has often dealt with and will continue to cover."
The authors have stressed that it is important that parents continue to give
their children medicines that have been prescribed for them, but to make their
family doctor or consultant aware of any adverse effects or problems their child
experiences.
###
Notes to editors
Prioritizing children's medicines for research: a pharmacoepidemiological study
of antiepileptic drugs. Ackers et al. British Journal of Clinical Pharmacology.
63.6, pp 689-697. June 2007.
The British Journal of Clinical Pharmacology is published monthly on behalf of
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and reports on all aspects of drug action in humans: invited review articles,
original papers, short communications and correspondence. The Journal, which was
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medical profession, clinical research and the pharmaceutical industry.
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