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Title Call for more research on children's medicines
Full Story

The number of children being prescribed anti-epilepsy drugs (AEDs) is on the rise, researchers said today.

They also called for more to be done to test the safety of medicines for youngsters.

Between 1993 and 2005, the number of prescriptions for AEDs for children rose by almost a fifth (19%) in the UK, a study found.

Experts called for more research into medicines for youngsters and into the the newer range of AEDs.

A House of Lords report published last year said 90% of medicines for newborns and 50% of those aimed at children were untested for those age groups.

According to the Medicines and Healthcare products Regulatory Agency (MHRA) more than half of all medicines used on children may not be tested properly.

At present, there is no legal requirement for companies to develop medicines for children but EU rules coming into force will set out new regulations.

Most drugs are not currently tested on children owing to the issues surrounding conducting clinical trials on children.

At present, the MHRA and and the Government is working on a strategy to improve information for parents and health professionals and establish guidelines for research into childhood medicines.

Today's study was led by experts from the School of Pharmacy at the University of London, the University College London Institute of Child Health and Great Ormond Street Hospital.

It involved studying more than 7,700 children up to the age of 18, from data in the UK General Practice Research Database.

All the children were prescribed AEDs between 1993 and 2005; 70% of them were prescribed one drug.

The researchers found that prescriptions for newer drugs had risen fivefold over the period, while prescriptions for older drugs fell by 17%.

A drug called lamotrigine accounted for 65% of the newer AED prescriptions and was the most-prescribed newer drug for children aged two to 18.

The researchers noted that prescriptions for one of the older drugs - vigabatrin (also known as Sabril) - had fallen after studies more than a decade ago showed it could affect people's sight.

Professor Ian Wong, from the Centre for Paediatric Pharmacy Research, said the European Medicines Agency (EMEA) had called for greater research into paediatric drugs for epilepsy.

He said: "EMEA recommended further research into 21 antiepileptic drugs for children but didn't indicate which ones should be prioritised.

"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."

The study also found that 54% of children receiving prescriptions were boys, and prescribing was highest among the 2-11 age group (45%).

Among children aged 12-18, that figure was 39% and 16% for children under two.

The researchers concluded: "There is a rapid increase in newer AED prescribing to children and adolescents in UK primary care, while prescribing of conventional AEDs is declining.

"Since 1997, the prevalence of vigabatrin has fallen, coinciding with the UK safety warnings on visual field defects.

"The uptake of lamotrigine, topiramate and levetiracetam is rapid and as the safety of these drugs has not been established, they should be prioritised for further research.

"Following concerns with vigabatrin, long-term safety surveillance of all newer AEDs is strongly recommended."

Prof Wong added: "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."

Dr Jeffrey Aronson, editor-in-chief of the British Journal of Clinical Pharmacology, which published the paper, said: "Many drugs are not tested on children before they are licensed because of the difficulties of including children in clinical trials.

"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."

Source: Press Association, 07/06/2007

Release Date 07/06/2007
Source Press Association, 07/06/2007
CountryUnited Kingdom

 

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