Introduction: In 2007 the Italian Drug Regulatory Agency activated the ADHD National Registry. The aims were pharmacovigilance, prevention of abuse/disuse, assessment of methylphenidate and atomoxetine efficacy and side effects. Patients and methods: Patients aged 6–17 years with ADHD treated by atomoxetine or MPH were enrolled. Complete clinical assessment was performed at enrolment and every 6 months; adverse events were investigated by questionnaires and data collected by centralized electronic CRF. Results: 1,452 patients were enrolled. 54% of these were prescribed with atomoxetine. For 64 patients (53 ATX) clinicians reported severe adverse events: dysphoria, suicidal ideation, anorexia, seizures, neurogenic bladder, aphasia, lengthened QT, tachycardia, hypotension. 19 patients discontinued medication (18 ATX), 2 changed to MPH. Discussion: The register was able to verify diagnostic accuracy and patterns of drug prescription establishing accurate benefit/risk balance and ensuring high level of health protection for the population. ATX was the most prescribed medication. Reports of adverse reactions and rate of early withdrawn were significantly higher for this medication than for MPH. Conclusion: The register may serve as model for others psychiatric disorders in children and adolescents.
Active pharmacovigilance in developmental neuropsychiatry: The Italian ADHD National Registry.
USALA, TATIANA;
2010-01-01
Abstract
Introduction: In 2007 the Italian Drug Regulatory Agency activated the ADHD National Registry. The aims were pharmacovigilance, prevention of abuse/disuse, assessment of methylphenidate and atomoxetine efficacy and side effects. Patients and methods: Patients aged 6–17 years with ADHD treated by atomoxetine or MPH were enrolled. Complete clinical assessment was performed at enrolment and every 6 months; adverse events were investigated by questionnaires and data collected by centralized electronic CRF. Results: 1,452 patients were enrolled. 54% of these were prescribed with atomoxetine. For 64 patients (53 ATX) clinicians reported severe adverse events: dysphoria, suicidal ideation, anorexia, seizures, neurogenic bladder, aphasia, lengthened QT, tachycardia, hypotension. 19 patients discontinued medication (18 ATX), 2 changed to MPH. Discussion: The register was able to verify diagnostic accuracy and patterns of drug prescription establishing accurate benefit/risk balance and ensuring high level of health protection for the population. ATX was the most prescribed medication. Reports of adverse reactions and rate of early withdrawn were significantly higher for this medication than for MPH. Conclusion: The register may serve as model for others psychiatric disorders in children and adolescents.Pubblicazioni consigliate
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