The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies

Abstract

BackgroundTo review empirical studies of adverse drug reactions (ADRs) reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD) symptoms in the pediatric population.MethodsPubMed, Embase, and PsycINFO® databases were searched from origin until June 2011. Studies reporting ADRs from amphetamine derivates, atomoxetine, methylphenidate, and modafinil in children from birth to age 17 were included. Information about ADR reporting rates, age and gender of the child, type, and seriousness of ADRs, setting, study design, ADR assessors, authors, and funding sources were extracted.ResultsThe review identified 43 studies reporting ADRs associated with medicines for treatment of ADHD in clinical studies covering approximately 7000 children, the majority of 6- to 12-year-old boys, and particularly in the United States of America (USA). The most frequently reported ADRs were decrease in appetite, gastrointestinal pain, and headache. There were wide variations in reported ADR occurrence between studies of similar design, setting, included population, and type of medication. Reported ADRs were primarily assessed by the children/their parents, and very few ADRs were rated as being serious. A large number of children dropped out of studies due to serious ADRs, and therefore, the actual number of serious ADRs from use of psychostimulants is probably higher. A large number of studies were conducted by the same groups of authors and sponsored by the pharmaceutical companies manufacturing the respective medications.ConclusionReported ADRs from use of psychostimulants in children were found in clinical trials of short duration. Since ADHD medications are prescribed for long-term treatment, there is a need for long-term safety studies. The pharmaceutical companies should make all information about ADRs reported for these medications accessible to the public, and further studies are needed on the impact of the link between researchers and the manufacturers of the respective products.

The long-term outcomes of interventions for the management of attention-deficit hyperactivity disorder in children and adolescents: a systematic review of randomized controlled trials

“…Therefore, the results cannot be attributable to one form of medication alone, and as a result of clinical (ie, adverse side effects) and personal decisions (ie, a desire to withdraw), some participants were unable to adhere to long-term treatment arms 62. Following their review of adverse events in studies lasting from 1 to 32 weeks, Aagaard and Hansen63 concluded that there was a lack of good evidence about adverse effects during long-term medication use.…”

Weight Considerations in Psychotropic Drug Prescribing and Switching

“…differences in appetite suppression between stimulants. 78 Switching from stimulants to atomoxetine is more likely to address the concern and may be tried as an alternative to switching between stimulants or as next step. Bupropion is also effective for ADHD both in youth 79 and adults.…”

Current Treatment of Selected Pediatric Sleep Disorders

“…Despite this, most published adverse drug reactions have not been serious [74,75], and the use of modafinil has been reported in the treatment of EDS in narcoleptic children [60,76,77]. Off-label use of the drug has also been reported in ADHD to be effective and well tolerated [78][79][80][81].…”