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An international research team has found that the most frequently prescribed medication for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, does not increase the risk of growth impairments, psychiatric or neurological adverse events in children and adolescents in the long-term.
Researchers from the Central Institute of Mental Health (CIMH) in Mannheim/Germany led by Prof. Dr. Dr. Tobias Banaschewski (Medical Director of the Clinic of Child and Adolescent Psychiatry and Psychotherapy and Deputy Director of the CIMH) conducted a naturalistic, prospective, controlled, longitudinal study with an international research team led by Researchers from UCL School of Pharmacy and University of Hong Kong (Dr Kenneth Man and Professor Ian Chi-Kei Wong) and Professor David Coghill, Department of Paediatrics, University of Melbourne. The findings have been published in “The Lancet Psychiatry”.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders, with a global prevalence of around 7 percent in children and 2 percent in adults. When untreated, individuals with ADHD are prone to adverse outcomes such as emotional problems, educational underachievement, exclusion from school, difficulties with employment and relationships, criminality and substance misuse.
Long-term safety of methylphenidate
Methylphenidate is the most frequently prescribed medication for the treatment of ADHD in children and adolescents in many countries. Short-term efficacy, tolerability, and safety have been demonstrated by many randomized controlled trials. However, data on long-term safety and tolerability of methylphenidate were scarce. As a result, methylphenidate, was rejected by the World Health Organization (WHO) for inclusion in their Essential Medicines List due to ‘concerns regarding the quality and limitations of the available evidence for both benefit and harm’. To address the concerns about long-term safety, the European Union funded the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) project. As part of the ADDUCE-project a two-year naturalistic study was conducted to assess the long-term adverse effects of methylphenidate on growth and development, psychiatric, neurological, and cardiovascular health outcomes.
Long-term methylphenidate use not associated with slow-down in growth
For the ADDUCE study a cohort of 1,410 children and adolescents from 27 European child and adolescent mental health centres in the UK, Germany, Switzerland, Italy, and Hungary were recruited. The study is unique in that it is the first prospective study to directly compare children and adolescents with ADHD who received long-term treatment with methylphenidate and those who did not receive pharmacotherapy.
The results of the study showed that long-term use of methylphenidate was not associated with impaired growth or with a higher risk of psychiatric or neurological symptoms but was associated with, albeit modest, average increases in systolic and diastolic blood pressure and pulse rate when comparing the methylphenidate group with the no-methylphenidate group. However, these increases are not considered to be serious or detrimental to health. Previous research from the ADDUCE project has also shown that treatment with methylphenidate does not increase the risk of suicide attempts and can reduce the risk of becoming a victim of physical abuse.
“Our findings show that the long-term treatment of children with ADHD with methylphenidate is generally safe and well-tolerated; however regular monitoring of pulse and blood pressure is necessary as higher increases in systolic and diastolic blood pressure and pulse rate are possible”, says Prof. Dr. Dr. Tobias Banaschewski, Medical Director of the Clinic of Child and Adolescent Psychiatry and Psychotherapy and Deputy Director of the Central Institute of Mental Health (CIMH).
This research was supported by the EU Seventh Framework Programme.
Kenneth K C Man, Alexander Häge, Tobias Banaschewski, Sarah K Inglis, Jan Buitelaar, Sara Carucci, Marina Danckaerts, Ralf W Dittmann, Bruno Falissard, Peter Garas, Chris Hollis, Kerstin Konrad, Hanna Kovshoff, Elizabeth Liddle, Suzanne McCarthy, Antje Neubert, Peter Nagy, Eric Rosenthal, Edmund J S Sonuga-Barke, Alessandro Zuddas, Ian C K Wong, David Coghill on behalf of the ADDUCE Consortium: Long-term safety of methylphenidate in children and adolescents with ADHD: 2-year outcomes of the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study. The Lancet Psychiatry, March 20, 2023. DOI: https://doi.org/10.1016/S2215-0366(23)00042-1
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