Pediatric Atomoxetine Ingestions Reported to Texas Poison Control Centers, 2003–2005

Abstract

Limited information exists on potentially adverse consequences following pediatric atomoxetine ingestions reported to poison control centers. Using pediatric atomoxetine ingestions reported to Texas poison control centers during 2003-2005, the proportion of cases involving serious outcomes (medical outcomes classified as moderate effects, major effects, death, or judged as potentially toxic exposures) was determined for selected variables and evaluated for statistical significance by calculating the rate ratio (RR) and 95% confidence interval (CI). Of 501 cases identified, 31 (6%) involved serious outcomes. Higher serious outcome rates were found with a maximum dose of >2.8 mg/kg or >200 mg or >4 tablets. Serious outcome rates were also higher if the exposure involved intentional self-harm or the patient was already at or en route to a health care facility when the poison control center was contacted or referred to a health care facility by the poison control center. The severity of the outcome associated with pediatric atomoxetine ingestions was dependent upon the dose and the circumstances of the ingestion (whether intentional self-harm was involved). The management of patients with serious outcomes was more likely to involve health care facilities. This information is useful for creating triage guidelines for the management of pediatric atomoxetine ingestions.

Analyzing Black Market Sales of the Second-Line ADHD Medication Atomoxetine

“…A review of clinical trial data reported an increased seizure rate of only 0.1-0.2% among children with ADHD who took atomoxetine compared to the placebo group [31]. Regarding cardiac effects, a regional poison control center study of 40 pediatric atomoxetine overdoses found that no arrythmias occurred [32]. Furthermore, the researchers concluded that activated charcoal and observation was adequate for management of tachycardia, hypertension, vomiting, and drowsiness following overdose.…”

Safety of non‐therapeutic atomoxetine exposures—a national poison data system study

“…Initial concerns of atomoxetine toxicity based on the results of small retrospective data (Lovecchio and Kashani, ; Forrester, ) are probably overstated. Atomoxetine exposures reported to the AAPCC seemed to be safe in the vast majority of cases over 8 years of observation.…”

“…It is of importance that only one such event was reported over a 9‐year period in a cohort of patients presumably at higher risk. Forrester () reported three cases of single agent atomoxetine ingestion classified as serious outcome in pediatric patients because of tachycardia and/or arterial hypertension. However, malignant arrhythmia was not reported.…”

“…Safety issues may be more prevalent in this vulnerable cohort of patients abusing the drug than in patients included in controlled clinical trials using the drug in therapeutic dose. Of interest, two retrospective studies raised questions about the toxicity (Lovecchio and Kashani, ) and safety (Forrester, ) of non‐therapeutic atomoxetine ingestions. We therefore aimed at determining the safety of non‐therapeutic atomoxetine exposures using the National Poison Database System (NPDS).…”

No stimulant? No Problem: Analyzing Black Market Sales of Atomoxetine on StreetRx

“…Smaller-scale reports have corroborated these findings. A study in Texas showed that 6% of the poison control center calls for pediatric ingestion of atomoxetine resulted in serious outcomes, with one seizure reported (Forrester, 2007). Additionally, an analysis of regional poison control centers found 40 patients who had overdosed on atomoxetine.…”