Risk assessment of isolated aripiprazole exposures and toxicities: a retrospective study.

STUDY

OBJECTIVE

To characterize the clinical effects of acute isolated aripiprazole poisonings and to assess the toxic dose of this drug.

METHODS

All isolated acute aripiprazole exposures reported to a poison control system from January 2002 through September 2006 were retrospectively reviewed. Patients with incomplete information or those lost to follow-up were excluded.

RESULTS

A total of 286 cases were identified. Mean age was 18.9 years (SD 15.7), with a range of 6 months-70 years. Seventy-seven patients (27%) were <or=6 years, 80 patients (28%) were 7-17 years, and 129 patients (45%) were >or=18 years. Doses were known in 255 patients (89%). Symptoms occurred in 158 patients (55%): somnolence 89 (56%), tachycardia 32 (20%, heart rate 102-186), nausea/vomiting 29 (18%), dystonic reactions 21 (13%), tremor 9 (6%), agitation 3 (2%), dizziness 3 (2%), paresthesia 2 (1%), headache 2 (1%), dysphagia 1 (<1%), syncope 1 (<1%), minor facial swelling 1 (<1%), and hypotension 1 (<1%). None of the patients required intubation, and there were no deaths or EKG abnormalities. Median dose for symptomatic and asymptomatic groups were 25 and 15 mg, respectively, for <or=6 years (p = 0.02); 60 and 30 mg for 7-17 years (p = 0.01); and 100 and 75 mg for >or=18 (p = 0.25). In comparison of drug groups (Group 1, <or=20 mg; Group 2, 21-90 mg; Group 3, >or=91 mg), symptoms were more likely to occur in Group 2 versus Group 1 (OR 2.29, 95% CI 0.79-6.61) in patients <or=6 years; in Group 3 versus Group 1 (OR 3.39, 95% CI 1.07-10.73) followed by Group 2 versus Group 1 (OR 1.14, 95% CI 0.36-3.56) in patients 7-17 years; and in Group 3 versus Group 1 (OR 1.36, 95% CI 0.54-3.42) but not any more likely in Group 2 versus Group 1 (OR 0.92, 95% CI 0.33-2.52) in patients >or=18 years.

CONCLUSIONS

Acute aripiprazole poisonings most commonly result in sedation, sinus tachycardia, nausea/vomiting, or dystonic reactions. Symptoms are more likely with doses above 90 mg, although pediatric patients can be affected at a lower dose.