Adverse Events in Very Young Children Prescribed Psychotropic Medications: Preliminary Findings from an Acute Clinical Sample.
OBJECTIVE
The present study used the Pediatric Adverse Events Rating Scale (PAERS) to provide a systematic assessment of adverse events (AEs) related to psychotropic medication use in a clinical sample of young children attending a specialized, early childhood partial hospital program. Study goals were as follows: 1) To describe the frequency and types of specific psychotropic medication-related AEs experienced by very young children (ages 3-7 years) in an acute clinical sample, and 2) to identify the psychotropic medication(s) and/or class(es) associated with the highest frequency of AEs.


METHODS
Participants were 158 children (118 males; ages 36-95 months, mean=66 months, SD=14.6 months) who presented to a hospital-based day treatment program for young children with severe emotional and behavioral problems, and were prescribed a psychotropic medication at any point during the hospitalization. Data on AEs related to psychotropic medication were collected using the PAERS from 2011 to 2014.


RESULTS
The percentages of children who experienced one or more AEs attributed to a psychiatric medication ranged from 0 (sertraline, melatonin) to 41.2% (fluoxetine), with wide variability in the types AEs reported. The overall frequencies of events caused by a stimulant were similar across the two medications examined (21.4% and 27.7% for mixed amphetamine salts and methylphenidate, respectively), with mood-related difficulties and decreased appetite being the most common AEs reported. The frequencies of AEs caused by an α agonist were also similar across the two medications examined (9.8% and 17.2% for guanfacine and clonidine, respectively), with fatigue as the most commonly reported AE. With respect to the selective serotonin reuptake inhibitor (SSRI) class, there was a trend for fluoxetine to be associated with more AEs (41.2%) than sertraline (for which no AEs were reported). The most common AEs reported for fluoxetine were impulsivity and poor concentration.


CONCLUSIONS
The data presented here support existing literature reporting differences in AEs between age groups. More rigorous studies are warranted to further examine the types and frequencies of AEs related to psychotropic medications in very young children.
1 Warren Alpert Medical School of Brown University , Department of Child and Adolescent Psychiatry, Providence, Rhode Island.|2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
Catherine S
CS
Lee
3 Bradley Hospital , Riverside, Rhode Island.
Lauren R
LR
Williamson
2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.|4 Simmons College , Boston Massachusetts.
Sarah E
SE
Martin
2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
Mia
M
DeMarco
1 Warren Alpert Medical School of Brown University , Department of Child and Adolescent Psychiatry, Providence, Rhode Island.|2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
Marta
M
Majczak
2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
Jane
J
Martini
1 Warren Alpert Medical School of Brown University , Department of Child and Adolescent Psychiatry, Providence, Rhode Island.|2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
Heather L
HL
Hunter
1 Warren Alpert Medical School of Brown University , Department of Child and Adolescent Psychiatry, Providence, Rhode Island.|3 Bradley Hospital , Riverside, Rhode Island.
Gregory
G
Fritz
1 Warren Alpert Medical School of Brown University , Department of Child and Adolescent Psychiatry, Providence, Rhode Island.|2 Pediatric Partial Hospital Program, Bradley Hospital , Riverside Rhode Island.
John
J
Boekamp
D002648:Child; D002675:Child, Preschool; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy*; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use
D011619:Psychotropic Drugs; D017367:Selective Serotonin Reuptake Inhibitors