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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

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
  1. 2‐21 years

  2. ≥ 1 prescription for methylphenidate, dexamphetamine or atomoxetine

Interventions Methylphenidate type: not stated
Methylphenidate dosage: not stated
Administration schedule: not stated
Duration of intervention: not stated
Treatment compliance: not stated
Outcomes Serious adverse events:
5 deaths:
  1. Patient aged 16‐21, cause of death: overdose. No active methylphenidate prescription. Comorbid anxiety/insomnia

  2. Patient aged 16‐21, cause of death: unknown. No active methylphenidate prescription. Comorbid depression

  3. Patient aged 16‐21, cause of death: stab wounds. No active methylphenidate prescription

  4. Patient aged 8‐15, cause of death: suicide. Active methylphenidate prescription

  5. Patient aged 8‐15, cause of death: suicide. Active methylphenidate prescription. Comorbid aggressive personality

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