Children and adolescent exposures to atomoxetine hydrochloride reported to a poison control center.
BACKGROUND
Atomoxetine hydrochloride, a selective norepinephrine reuptake inhibitor was FDA approved for patients with attention-deficit/hyperactivity disorder. Little is known about adverse drug reactions of atomoxetine following an overdose among children. The objective of our study was to evaluate the type of atomoxetine adverse drug reactions in relation to dose.


METHODS
We evaluated children exposed to atomoxetine reported to a poison center from January-December 2004.


RESULTS
Sixty-four cases met all inclusion criteria. Twenty-one patients had an adverse drug reaction (15 at dosage range 0.52-6.25 mg/kg): agitation, headache, erythema, rash, elevated blood pressure and heart rate, nausea, emesis, and lethargy. In 51 patients, weights were known: group 1 (n = 43) received higher than maximum recommended doses >1.4 mg/kg and group 2 (n = 8) received < or = 1.4 mg/kg. There were no differences in adverse drug reactions in group 1 versus 2. Eight patients were admitted to a healthcare facility and all were discharged without any sequelae. Hypertension occurred in 3 of 9 patients for whom blood pressure was recorded.


CONCLUSIONS
At the doses reported, adverse drug reactions did not correlate with atomoxetine dose. Hypertension may occur in some patients following atomoxetine overdose.
Stojanovski
Sasko D
SD
College of Pharmacy, Ohio State University and Children's Research Institute, Columbus 43210, USA.
Robinson
Renee F
RF
Baker
S David
SD
Casavant
Marcel J
MJ
Hayes
John R
JR
Nahata
Milap C
MC
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D016907:Adverse Drug Reaction Reporting Systems; D000069445:Atomoxetine Hydrochloride; D002648:Child; D004305:Dose-Response Relationship, Drug; D006801:Humans; D011039:Poison Control Centers; D011437:Propylamines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride