Fears over child epilepsy drugs Urgent safety studies are needed for newer antiepilepsy drugs that are being increasingly prescribed for children, say UK researchers. The British Journal of Clinical Pharmacology report says prescriptions have risen fivefold in 13 years. Yet the drugs' longterm safety has not been established, say the researchers. Many medicines are not fully tested on children before licensing, meaning consultants have no official guidance on doses to refer to when prescribing. The uptake of these drugs has been rapid, yet their longterm safety has not been established 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 antiepileptic drugs given to nearly 8,000 children over a 13year period. The centre is 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. Professor Wong and his colleagues found three drugs in particular lamotrigine, topiramate and levetiracetam had seen a "massive" rise in prescribing. Professor Wong said this was concerning. "The uptake of these drugs has been rapid, yet their longterm safety has not been established and further research must now be seen as a priority." Sideeffects He said 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 sideeffects in children became more apparent. He said multiorgan failure, renal failure, blood disorders and skin reactions had been reported in patients using lamotrigine. When you are prescribing a drug 'off licence' to a child, it's important to let the family know exactly the implications of this
Dr Colin Ferrie, consultant paediatric neurologist Dr Jeffrey Aronson, a reader in clinical pharmacology at Oxford University, said many drugs were not tested on children because of the difficulties that including children in clinical trials posed. "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," he said. 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 calculate a safe and effective dose of a drug." Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr//1/hi/health/6734987.stm Published: 2007/06/10 23:16:55 GMT © BBC MMVII