Changing patterns of alpha agonist medication use in children and adolescents 2009-2011.
OBJECTIVE
The purpose of this study was to describe rates and patterns of long- and short-acting alpha agonist use for behavioral problems in a primary care population following Food and Drug Administration (FDA) approval of the long-acting alpha agonists guanfacine and clonidine.


METHODS
Children and adolescents 4-18 years of age, who received an alpha agonist prescription between 2009 and 2011, were identified from a sample of 45 United States primary care practices in two electronic health record-based research networks. Alpha agonist receipt was identified using National Drug Codes and medication names. The proportion of subjects receiving long- and short-acting prescriptions in each year was calculated and examined with respect to reported mental health diagnoses, and whether indications for use were on-label, had evidence from clinical trials, or had no trial evidence.


RESULTS
In a cohort of 282,875 subjects, 27,671 (10%) received any psychotropic medication and only 4,227 subjects (1.5%) received at least one prescription for an alpha agonist, most commonly a short-acting formulation (83%). Only 20% of alpha agonist use was on-label (use of long-acting formulations for attention-deficit/hyperactivity disorder [ADHD]). Most subjects (68%) received alpha agonists for indications with evidence of efficacy from clinical trials but no FDA approval, primarily short-acting formulations for ADHD and autism; 12% received alpha agonists for diagnoses lacking randomized clinical trial evidence in children, including sleep disorders and anxiety, or for which there was no documented mental health diagnosis. Rates of long-acting alpha agonist use increased more than 20-fold from 0.2% to 4%, whereas rates of short-acting alpha agonist use grew only slightly between 2009 and 2011 from 10.6% to 11.3%.


CONCLUSIONS
Alpha agonist use was uncommon in this population, and most subjects received short-acting forms for conditions that were off-label, but with clinical trial evidence. The safety and efficacy of use for conditions, including sleep disorders and anxiety, lacking evidence from randomized trials, warrant further investigation.
1 The Pediatric Research Consortium at the Children's Hospital of Philadelphia , Philadelphia, Pennsylvania.
Alexander G
AG
Fiks
Stephanie L
SL
Mayne
Lihai
L
Song
Jennifer
J
Steffes
Weiwei
W
Liu
Banita
B
McCarn
Benyamin
B
Margolis
Alan
A
Grimes
Edward
E
Gotlieb
Russell
R
Localio
Michelle E
ME
Ross
Robert W
RW
Grundmeier
Richard
R
Wasserman
Laurel K
LK
Leslie
D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D017277:Drug Approval; D057286:Electronic Health Records; D005260:Female; D006801:Humans; D008297:Male; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D000316:Adrenergic alpha-Agonists