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

Clin Toxicol (Phila). 2009 Jul;47(6):580-3. doi: 10.1080/15563650902980027.

Abstract

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.

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Aged
  • Antipsychotic Agents / poisoning*
  • Aripiprazole
  • Child
  • Child, Preschool
  • Disorders of Excessive Somnolence / etiology
  • Disorders of Excessive Somnolence / physiopathology
  • Dose-Response Relationship, Drug
  • Dystonia / etiology
  • Dystonia / physiopathology
  • Female
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Nausea / etiology
  • Nausea / physiopathology
  • Piperazines / poisoning*
  • Poison Control Centers
  • Poisoning / etiology*
  • Poisoning / physiopathology
  • Quinolones / poisoning*
  • Retrospective Studies
  • Risk Assessment
  • Tachycardia, Sinus / etiology
  • Tachycardia, Sinus / physiopathology
  • Vomiting / etiology
  • Vomiting / physiopathology
  • Young Adult

Substances

  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole