Pediatric ADHD Medication Exposures Reported to US Poison Control Centers

King, Samantha A.; Casavant, Marcel J.; Spiller, Henry A.; Hodges, Nichole L.; Chounthirath, Thiphalak; Smith, Gary A.

doi:10.1542/peds.2017-3872

Cited by 23 publications

(20 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In 2017, an estimated 5.8 million U.S. individuals aged ‡12 years reported past-year prescription stimulant NMU (Center for Behavioral Health and Statistics and Quality 2017). Prescription stimulant NMU is associated with serious adverse health outcomes and places a substantial burden on health care facility utilization (Substance Abuse and Mental Health Services Administration 2013; King et al 2018;Faraone et al 2019).…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of AR19, an Immediate-Release Amphetamine Sulfate Formulation Designed to Deter Manipulation for Administration Via Nonoral Routes: Bioequivalence to Reference Racemic Amphetamine Sulfate, Dose Proportionality, and Food Effect

Caras

Sharpe

2020

Journal of Child and Adolescent Psychopharmacology

View full text Add to dashboard Cite

Objectives: We evaluated the pharmacokinetics (PK) of an investigational immediate-release amphetamine (AMP) sulfate formulation (AR19) designed to deter nonoral administration versus reference racemic amphetamine sulfate (RA-AMPH). We investigated AMP bioavailability from AR19, the effect of taking AR19 with food or sprinkling the capsules on food, and dose proportionality. Methods: Participants received AR19 (20 mg) or reference RA-AMPH (20 mg) (bioequivalence study) or AR19 5 or 30 mg (dose comparison study). Food effect study participants received AR19 (20 mg) as intact capsule while fasted or after highfat/-calorie meal, or as pellets sprinkled on applesauce or yogurt ( ‡6-day washout). Blood samples were analyzed for dextroamphetamine (d-AMP) and levoamphetamine (l-AMP) PK: C max , AUC last , AUC inf , k z , T ½ , and T max . Safety was assessed. Results: Bioequivalence, dose comparison, and food effect studies included 36, 24, and 36 participants. The 90% confidence intervals (CIs) of C max , AUC last , and AUC inf for AR19 20 mg versus reference RA-AMPH or AR19 with intact capsule and meal or sprinkled AR19 pellets on food versus fasted were between 80% and 125%. Dose-normalized C max /D, AUC last /D, and AUC inf /D for AR19 5 versus 30 mg had CIs within 80%-125%. Meanstandard deviation (SD) T max was comparable for AMP (d-AMP; l-AMP) following AR19 20 mg (2.84 -1.05; 3.05 -1.22) versus reference RA-AMPH (2.52 -0.75; 2.75 -1.00), and AR19 5 mg (2.48 -0.57; 2.65 -0.65) versus AR19 30 mg (2.55 -0.56; 2.72 -0.65). Mean -SD T max for AMP (d-AMP; l-AMP) was higher with intact capsule and meal (5.59 -1.57; 5.59 -1.59) versus fasted (2.85 -0.76; 2.97 -0.79). No serious adverse events were reported. Conclusion: AR19 was bioequivalent to reference RA-AMPH. Bioavailability was similar at doses between 5 and 30 mg and was not impacted by meal consumption or sprinkling on food. AR19 at tested doses was well tolerated.

show abstract

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of AR19, an Immediate-Release Amphetamine Sulfate Formulation Designed to Deter Manipulation for Administration Via Nonoral Routes: Bioequivalence to Reference Racemic Amphetamine Sulfate, Dose Proportionality, and Food Effect

Caras

Sharpe

2020

Journal of Child and Adolescent Psychopharmacology

View full text Add to dashboard Cite

show abstract

“…For children and adolescents, King et al (2018) examined NMU exposures of ADHD medications using data from the National Poison Data System (NPDS) from 2000 through 2014. During this period, 156,365 ADHD medication exposures had been reported.…”

mentioning

confidence: 99%

Prevalence and Consequences of the Nonmedical Use of Amphetamine Among Persons Calling Poison Control Centers

2019

View full text Add to dashboard Cite

Objective: To describe consequences of the nonmedical use (NMU) of prescription amphetamines (AMPs). Method: Data from the U.S. National Poison Data System yielded four groups: intravenous NMU ( IV NMU) intentionally injected AMP, Nasal NMU intentionally inhaled AMP but did not inject, Oral NMU intentionally ingested AMP, and controls reported unintentional oral exposure to AMP. Results: The Nasal NMU group was at greater risk of admission to a health care facility. All NMU groups were at greater risk for adverse clinical effects. IV NMU had the greatest number of adverse effects, followed by Nasal and Oral NMU. Nasal NMU had a greater risk for major medical outcomes versus Oral NMU. The IV NMU group was 21.9 times more likely to die from AMP NMU than controls. Oral NMU conferred a significantly greater risk of suicide attempts. Conclusion: Oral and nonoral NMU of AMP are associated with significant risks of morbidity and mortality.

show abstract

“…33 Adoption of similar primary prevention approaches to those for opioids is warranted, such as judicious prescribing, and avoidance where possible of co-prescription of benzodiazepines with opioids. 25,34 Reports of increased use of non-opioid pharmaceuticals (e.g., gabapentinoids, [35][36][37] loperamide, 38,39 and stimulants 40 ) have prompted concerns for missing the next drug epidemic, but neither large numbers nor high severity of ED visits attributed to other pharmaceuticals were identified. Only 29% of estimated ED visits for nonmedical use did not involve opioids or benzodiazepines, and these visits were less likely than visits involving opioids or benzodiazepines to involve severe manifestations of unresponsiveness or cardiorespiratory failure (9.6%).…”

Section: Discussionmentioning

confidence: 99%

U.S. Emergency Department Visits Resulting From Nonmedical Use of Pharmaceuticals, 2016

Geller

Dowell

Lovegrove

et al. 2019

American Journal of Preventive Medicine

View full text Add to dashboard Cite

Introduction: National data on morbidity from nonmedical use of pharmaceuticals are limited. This study used nationally representative, public health surveillance data to characterize U.S. emergency department visits for acute harms from nonmedical use of pharmaceuticals and to guide prevention efforts. Methods: Data collected in 2016 from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project were analyzed in 2018 to calculate national estimates of emergency department visits for harms from nonmedical use of pharmaceuticals. Results: From review of 5,130 cases, there were an estimated 358,247 emergency department visits (95% CI=280,675, 435,819) in 2016 for harms from nonmedical use of pharmaceuticals and 41.1% resulted in hospitalization (95% CI=32.3%, 49.8%). One half (50.9%, 95% CI=46.6%, 55.3%) of estimated visits involved patients aged ≤34 years; more than one half of estimated visits also involved non-pharmaceutical substances (52.9%, 95% CI=49.7%, 56.1%), including illicit drugs in 34.1% (95% CI=30.9%, 37.2%) and alcohol in 21.8% (95% CI=19.8%, 23.9%). Overall, benzodiazepines were implicated in 46.9% (95% CI=42.5%, 51.2%) of estimated emergency department visits for nonmedical use of pharmaceuticals but were the only substance implicated in just 6.5% (95% CI=5.1%, 7.9%). Prescription opioids were implicated in 36.2% (95% CI=30.8%, 41.7%) of estimated emergency department visits and were the only substance implicated in 11.3% (95% CI=8.6%, 14.0%).

show abstract

Pediatric ADHD Medication Exposures Reported to US Poison Control Centers

Abstract: Unintentional and intentional pediatric exposures to ADHD medications are an increasing problem in the United States, affecting children of all ages.

Cited by 23 publications

References 28 publications

Pharmacokinetics of AR19, an Immediate-Release Amphetamine Sulfate Formulation Designed to Deter Manipulation for Administration Via Nonoral Routes: Bioequivalence to Reference Racemic Amphetamine Sulfate, Dose Proportionality, and Food Effect

Pharmacokinetics of AR19, an Immediate-Release Amphetamine Sulfate Formulation Designed to Deter Manipulation for Administration Via Nonoral Routes: Bioequivalence to Reference Racemic Amphetamine Sulfate, Dose Proportionality, and Food Effect

Prevalence and Consequences of the Nonmedical Use of Amphetamine Among Persons Calling Poison Control Centers

U.S. Emergency Department Visits Resulting From Nonmedical Use of Pharmaceuticals, 2016

Contact Info

Product

Resources

About