UK Researchers Call for Safety Studies of New Anti-epilepsy Drugs for Children

by Gopalan on  June 11, 2007 at 12:26 PM Drug News   - G J E 4
UK Researchers Call for Safety Studies of New Anti-epilepsy Drugs for Children
Prescriptions for newer anti-epilepsy drugs have risen five-fold in the last 13 years, but their long-term safety remains to be established, say UK researchers.

A report in The British Journal of Clinical Pharmacology notes many medicines are not fully tested on children before licensing, meaning consultants have no official guidance on doses 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 Pediatric Pharmacy Research in London, studied antiepileptic drugs given to nearly 8,000 children over a 13-year 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.

"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," said Wong.

He noted 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 lamotrigine.

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 pediatric use, which is widely regarded as most unsatisfactory," he said.

Dr Colin Ferrie, a consultant pediatric 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 license.

"Obviously it's an area of concern, and when you are prescribing a drug 'off license' 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."

Source: Medindia

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