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

Gross‐Tsur 2004.

Methods A patient series of 3 children with ADHD who manifested hallucinations during methylphenidate treatment at low therapeutic doses
Participants Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (33.3%), not stated (66.6%))
Age: 7, 12, 7½ years old
IQ: > 70
Sex: male
Ethnicity: not stated
Country: Israel
Comorbidity: ODD (33%), cerebral palsy (33%), mild learning disabilities (33%)
Comedication: not stated
Sociodemographics: adopted (33%)
Interventions Methylphenidate type: not stated
Methylphenidate dosage: 0.25‐0.3 mg/kg, 7.5‐10 mg
Administration schedule: once daily
Duration of treatment: 1 for a short period, 2 for several months/1 year
Treatment compliance: not stated
Outcomes Serious adverse events:
Complex visual and haptic hallucinations
Case 1
Methylphenidate, 1 year: visual and haptic hallucinations starting around 1 hour after drug ingestion
Placebo substitution of methylphenidate: immediate cessation of hallucinations
> 2 years follow‐up: no psychiatric symptoms reappeared
Case 2
Methylphenidate, short period: visual and haptic hallucinations starting 2 hours after drug ingestion, continuing for almost 2 hours
Discontinuation of methylphenidate: no recurrence
Re‐challenge with methylphenidate: immediate recurrence of hallucinations
3‐year follow‐up: uneventful
Case 3
Methylphenidate, several months: visual and haptic hallucinations
Discontinuation of methylphenidate: hallucinations ceased
2‐year follow‐up: no recurrence
Notes Funding/vested interests: the authors received a 1‐year research grant in excess of USD 10,000 from Novartis in 1997
Authors' affiliations: no other affiliations to pharmaceutical companies stated
Key conclusions of the study authors: we describe 3 children with ADHD who were treated with low doses of methylphenidate and developed complex visual and haptic hallucinations
Comments from the study authors: the causal role of methylphenidate in the development of hallucinations was based on their appearance after ingestion of the drug, resolving after its withdrawal, and the absence of psychiatric comorbidity that could explain such phenomena. In 1 patient, the hallucinations reappeared after an inadvertent re‐challenge. Because methylphenidate is a widely used, well‐studied, and safe pharmacologic agent, physicians who prescribe methylphenidate should be aware of even rare adverse manifestations occurring at therapeutic doses
Supplemental information regarding IQ and ADHD diagnostic criteria received through personal email correspondence with the authors in October 2013 (Shalev 2013 [pers comm])