Atomoxetine-induced hepatitis in a child.
OBJECTIVE
To report a case of hepatitis associated with atomoxetine hydrochloride use and to describe the previously-unpublished severe cases of this syndrome.


METHODS
An eight-year-old female with attention deficient hyperactive disorder (ADHD) was treated with atomoxetine hydrochloride. She complained of increased abdominal pain and occasional emesis; her transaminases and bilirubin were markedly elevated. She was admitted to a tertiary-care pediatric hospital and treated for drug-induced hepatitis. Atomoxetine was discontinued and supportive care was instituted. A liver biopsy showed hepatitis with moderate piecemeal necrosis. Clinical status and liver function tests improved over 13 days of hospitalization.


CONCLUSIONS
To our knowledge this is the first published severe case of atomoxetine-induced hepatitis. The International Organization of Medical Science Diagnostic Scale and the Adverse Drug Reaction Probability Scale by Naranjo et al. were applied to assess causality. Both scales indicated the association of atomoxetine and hepatitis as "probable;" a positive rechallenge would have made this association "definitive." This potential serious adverse reaction should be considered in children receiving atomoxetine therapy.
Stojanovski
Sasko D
SD
College of Pharmacy, Ohio State University and Children's Research Institute, Columbus, Ohio 43210, USA.
Casavant
Marcel J
MJ
Mousa
Hayat M
HM
Baker
Peter
P
Nahata
Milap C
MC
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects*; D000069445:Atomoxetine Hydrochloride; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology* / Q000473:pathology; D002648:Child; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000473:pathology; D008111:Liver Function Tests; D009336:Necrosis; D011437:Propylamines / Q000009:adverse effects*; D016896:Treatment Outcome; D028761:Withholding Treatment
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride