McCarthy 2009.
Methods | A retrospective cohort study of methylphenidate, dexamphetamine and atomoxetine use | |
Participants | Number of participants screened: approximately 3 million Number of participants included: 5351 Number of participants followed up: not stated Number of withdrawals: not stated Diagnosis of ADHD: not stated (subtype: not stated) Age: mean not stated, range: 2‐21 years old IQ: not stated Sex: not stated Methylphenidate‐naïve: not stated Ethnicity: not stated Country: UK Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria
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Interventions | Methylphenidate type: not stated Methylphenidate dosage: not stated Administration schedule: not stated Duration of intervention: not stated Treatment compliance: not stated |
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Outcomes |
Serious adverse events: 5 deaths:
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Notes | Sample calculation: not stated
Ethics approval: ethics approval for the study was granted by the Independent Scientific Advisory Commitee for the Medicines and Healthcare products Regulatory Agency (MHRA) database research
Funding/vested interests: the School of Pharmacy has received an education grant from Janssen Cilag for professional continued development courses. No specific funding was obtained for the conduct of this study. Ian Wong was funded by a UK Department of Health Public Health Career Scientist Award to investigate the safety of psychotropic drugs in children. Eric Taylor and CK Wong were members of the NICE guideline committee for the diagnosis and management of ADHD in children, young people and adults. The other authors have no conflict of interests relevant to the content of this study Key conclusions of the study authors: in this study, it was not possible to demonstrate an increase in the risk of sudden death associated with methylphenidate, dexamphetamine or atomoxetine. Although it was not an initial aim of this study, an increase in the risk of suicide was observed, particularly in the younger teenager category Comments from the study authors: clinicians should identify patients at increased risk for cardiovascular events and those patients at increased risk for suicide, particularly males with co‐morbid conditions, and monitor them appropriately Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated |