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.
Annette Whibley | alfa
Multi-year study finds 'hotspots' of ammonia over world's major agricultural areas
17.03.2017 | University of Maryland
Diabetes Drug May Improve Bone Fat-induced Defects of Fracture Healing
17.03.2017 | Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke
The Institute of Semiconductor Technology and the Institute of Physical and Theoretical Chemistry, both members of the Laboratory for Emerging Nanometrology (LENA), at Technische Universität Braunschweig are partners in a new European research project entitled ChipScope, which aims to develop a completely new and extremely small optical microscope capable of observing the interior of living cells in real time. A consortium of 7 partners from 5 countries will tackle this issue with very ambitious objectives during a four-year research program.
To demonstrate the usefulness of this new scientific tool, at the end of the project the developed chip-sized microscope will be used to observe in real-time...
Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.
The results will be published on March 22 in the journal „Astronomy & Astrophysics“.
Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...
Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.
Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...
In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...
20.03.2017 | Event News
14.03.2017 | Event News
07.03.2017 | Event News
29.03.2017 | Health and Medicine
29.03.2017 | Earth Sciences
29.03.2017 | Trade Fair News