Azithromycin-induced agitation and choreoathetosis.

We report a child who developed agitation and choreoathetoid movements with azithromycin therapy on 2 separate occasions. In both instances, the symptoms resolved when the antibiotic was discontinued. By means of the Naranjo adverse drug reaction probability scale, we classified this event as a probable adverse drug reaction (score of 6 points). To our knowledge, this is the first published case of azithromycin-induced agitation with choreoathetosis. Because this is a widely used medication for many common infectious conditions, including otitis media and pneumonia, this potential serious adverse reaction should be considered.

Implications of diphenhydramine single-dose unintended ingestions in young children.

BACKGROUND: Diphenhydramine is frequently used in children, but the consequences of single unintended dose exposures in young children are unknown. METHODS: We evaluated 2000-2001 American Association of Poison Control Centers-Toxic Exposure Surveillance data on children exposed to diphenhydramine ingestions. RESULTS: Nine hundred twenty-six cases met the inclusion criteria; 49.1% were men, mean age was 29.7 +/- 13.0 months (range, 1-72 months). Approximately 85% of unintentional exposures occurred in 1- to 3-year-old children. The mean dose ingested was 6.4 +/- 6.1 mg/kg (median, 4.6 mg/kg). Thirty-two percent of patients were symptomatic: minor (29.4%), moderate (2.9%), and severe (0.11%). There was no relationship between dose and symptom severity. Diphenhydramine dose ingestion of 7.5 mg/kg or greater was not a predictor of severity (P = 0.47) CONCLUSIONS: The relationship between ingested dose and severity of symptoms was insignificant.

Trends in medication prescribing for pediatric sleep difficulties in US outpatient settings.

OBJECTIVES: This study examined trends in physician-prescribing of medications for children with sleep difficulties in outpatient settings in the US. Additionally, we explored the incidence of physician prescribing patterns of medications with high abuse potential for children with sleep difficulties. METHODS: A cross-sectional study was conducted on patients aged < or =17 years with sleep difficulties from 1993-2004 using data from the National Ambulatory Medical Care Survey (NAMCS). Office visits were considered related to sleep difficulties if relevant ICD-9 codes were recorded and if sleep difficulties were reported as the reason for the visits. Medications were retrieved using the NAMCS drug codes, and all analyses were weighted to determine national estimates. RESULTS: During 1993 to 2004, approximately 18.6 million visits occurred for sleep related difficulty in children. The highest percentage of visits were by school-aged children (6 to 12 years). Pediatricians saw 35% of patients, psychiatrists saw 24%, and general/family practice physicians saw 13% of the patients. Eighty-one percent of visits among children with sleep difficulties resulted in a prescription for a medication. Many of these medications prescribed lack FDA approved labeling to assure their effectiveness and safety in this population. CONCLUSION: The findings of this study suggest that physicians frequently prescribed medications for sleep difficulties in children in US outpatient settings. Of particular concern is prescribing of many unapproved medications for this population.

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. CASE SUMMARY: 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. DISCUSSION: 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.

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. CONCLUSION: At the doses reported, adverse drug reactions did not correlate with atomoxetine dose. Hypertension may occur in some patients following atomoxetine overdose.