Children and adolescent exposures to atomoxetine hydrochloride reported to a poison control center. 2006

Sasko D Stojanovski, and Renee F Robinson, and S David Baker, and Marcel J Casavant, and John R Hayes, and Milap C Nahata
College of Pharmacy, Ohio State University and Children's Research Institute, Columbus 43210, USA.

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.

UI MeSH Term Description Entries
D011039 Poison Control Centers Facilities which provide information concerning poisons and treatment of poisoning in emergencies. Centers, Poison Control,Center, Poison Control,Control Centers, Poison,Poison Control Center
D011437 Propylamines Derivatives of propylamine (the structural formula NH2CH2CH2CH3).
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D004305 Dose-Response Relationship, Drug The relationship between the dose of an administered drug and the response of the organism to the drug. Dose Response Relationship, Drug,Dose-Response Relationships, Drug,Drug Dose-Response Relationship,Drug Dose-Response Relationships,Relationship, Drug Dose-Response,Relationships, Drug Dose-Response
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069445 Atomoxetine Hydrochloride A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER. Atomoxetine,Atomoxetine HCl,LY 139603,N-methyl-gamma-(2-methylphenoxy)benzenepropanamine hydrochloride,Strattera,Tomoxetine,Tomoxetine Hydrochloride, (+)-isomer - T351671,Tomoxetine Hydrochloride, (+-)-isomer,Tomoxetine Hydrochloride, (-)-isomer,139603, LY,HCl, Atomoxetine,Hydrochloride, Atomoxetine
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D016907 Adverse Drug Reaction Reporting Systems Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions. Adverse Drug Reaction Reporting System,Drug Reaction Reporting Systems, Adverse
D018759 Adrenergic Uptake Inhibitors Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. Adrenergic Reuptake Inhibitors,Inhibitors, Adrenergic Reuptake,Inhibitors, Adrenergic Uptake,Reuptake Inhibitors, Adrenergic,Uptake Inhibitors, Adrenergic

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