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Medications prescribed for attention-deficit/hyperactivity disorder (ADHD) have been associated with acute psychiatric symptoms, including hallucinations (commonly, visual and tactile sensations of insects, snakes, or worms) and mania (elevated mood, increased energy, unusual thought patterns). To clarify the capacity for psychostimulants to cause such psychiatric events, FDA investigators reviewed clinical trials, cases of drug-related psychosis reported to the FDA Adverse Event Reporting System (2002–2005), and manufacturers’ postmarketing surveillance records.
Analysis of 49 pediatric randomized, controlled trails revealed that of 5717 ADHD patients, 11 (0.19%) experienced psychotic or manic events while receiving methlyphenidate, ampheta…