ADHD drugs re-evaluated
ADHD, a common childhood neurodevelopmental disorder, has high socioeconomic costs. Growing safety concerns regarding MPH led to the establishment of the EU-funded project ADDUCE (Attention deficit hyperactivity disorder drugs use chronic effects). The consortium used multiple pharmaco-epidemiological research methods to determine the impact of MPH on children and adolescents. These included a series of retrospective and prospective pharmacovigilance studies. Also investigated were prevalence, clinical significance, development, and moderating and/or mediating factors of MPH for four specific classes: growth, neurological, psychiatric and cardiovascular. Providing a basis for subsequent clinical study, researchers produced reviews and reports from the available literature on the long-term adverse effects of MPH treatment. These are specific to growth and pubertal development, and explore the drug's neurological, psychiatric and cardiovascular effects. By August 2014, ADDUCE members successfully enrolled 1 370 children into 3 cohorts for prospective observational pharmacovigilance studies over a 24-month period. A first, the use of two control groups has provided data of high clinical value as clinicians can differentiate between adverse effects resulting from ADHD and the side-effects of the treatment. Another key achievement was the development and pilot testing of the Medication and Cognition Rating Scale for children and adults. In addition, ADDUCE has developed a tool to detect and utilise measures of bone maturation to identify and predict long-term growth retardation resulting from drug consumption. The beauty of these tools is that they can also be used for assessing the effects of other stimulant medications on cognition and growth. Project outcomes have resulted in several publications in leading international journals and other manuscripts are also in preparation. Results were disseminated widely at several international conferences and meetings as well as to key stakeholders such as the European Medicines Agency (EMA), national organisations, patients, medical professionals and the public. ADDUCE has systematically evaluated the safety and efficacy of long-term MPH treatment for ADHD sufferers. These findings are expected to directly impact clinical guidelines and regulatory advice for ADHD management. This, in turn, should promote safe, high-quality, evidence-based effective care for ADHD patients and significantly improve their quality of life.
Keywords
ADHD, methylphenidate, ADDUCE, pharmacovigilance, MPH treatment
