Dear Editor,
Alcohol-based hand sanitizers (ABHS) are increasingly being used during the Coronavirus Disease 2019 (COVID-19) pandemic. The first U.S. case was identified in late January 2020. ABHS contain at least 60% ethanol or 70% isopropanol [1] and carry safety risks. In April 2020, FDA identified a 79% increase in ABHS exposures reported to U.S. Poison Control Centers (PCCs) compared to 2019, primarily affecting young children [2]. A Centers for Disease Control and Prevention survey showed nearly half of adult respondents were unaware hand sanitizers should be kept out of children’s reach [3].
To increase understanding of ABHS effects in children ≤5 years, we searched the American Association of Poison Control Centers’ (AAPCC) National Poison Data System from January-April 2020. We included ABHS calls regardless of exposure reason or appropriateness of use.
We identified 4451 exposures in children ≤5 years (range 5 days to 5 years, median 1.9 years). NPDS received an increase in cases (35.8%) from January (n = 904) to April 2020 (n = 1228), consistent with rising demand for hand sanitizers during the COVID-19 pandemic. Ethanol ABHS exposure (98.7%, 4392/4451) was most common; isopropanol ABHS exposure was minimal (1.3%, 59/4451). Ingestion (94.0%, 4184/4451) was the primary route, followed by ocular (5.5%, 256/4451). Of 81 children referred for medical evaluation, five (0.1%, 5/4451) were hospitalized. Unintentional exposures accounted for 99.8% (4442/4451) of calls. Primary residence was the most common setting (96.1%, 4278/4451), which may coincide with COVID-19 quarantine and increased access. In contrast, non-residence settings (e.g., schools, health care facilities) were less frequent (3.9%, 173/4451).
Clinical effects were assessed as related (i.e., timing/signs/ symptoms were consistent with exposure) for 12.4% (554/ 4451) of exposures. Of 554 related effects, 50% were ocular (279/554), 56.1% were gastrointestinal (311/554), and 5.6% were central nervous system (CNS)-related (31/554); some exposures reported multiple effects.
Quantity was reported for 56.9% (315/554) related effects, of which 1.3% (4/315) experienced a major/moderate effect from a small amount of ABHS [i.e., CNS depression (mouthful), edema/conjunctivitis (ocular)]. (Table 1) A threshold dose above which ethanol toxicity will occur has not been established and effects vary among individuals. In young children, CNS depression and hypoglycemia can occur with blood ethanol concentrations of 50 mg/dL (estimated 6mL ethanol 80% ingestion in an 11 kg toddler); convulsions and potentially fatal hypoglycemia can occur with blood ethanol concentrations of 100 mg/dL (estimated 11 mL ethanol 80% ingestion in an 11 kg toddler) [4–6]. ABHS exposures in this report included CNS depression (n = 20) and hypoglycemia/ ataxia (n = 1). No deaths were reported; however, deaths that occur outside of health care facilities are unlikely to be reported to PCCs.
Table 1.
ABHS exposures to children ≤5 years and associated substance quantities, reported to U.S. Poison Centers from January 1, 2020 to April 30, 2020 (n = 315/4451)a.
| Substance quantity (exact, estimate or maximum possible), as reported in ranges | Minor/minimal outcome (n = 311) | Moderate outcome (n = 3 | Major outcome (n = 1) | |||
|---|---|---|---|---|---|---|
| n | % | n | % | n | % | |
|
Taste/lick/drop 1–3 range (1 median) |
183 | 58.8 | 2 | 66.7 | 1 | 100.0 |
|
Millilitersb 1–60 range (15.4 median) |
53 | 17.0 | 0 | 0 | 0 | 0 |
|
Mouthful 0.5–3 range (1.1 median) |
51 | 16.4 | 1 | 33.3 | 0 | 0 |
|
Sips 1–2 range (1.1 median) |
13 | 4.2 | 0 | 0 | 0 | 0 |
|
Bitesc 1–3 range (1.2 median) |
9 | 2.9 | 0 | 0 | 0 | 0 |
|
Solid (tab/pill/capsule)d 1 |
1 | 0.3 | 0 | 0 | 0 | 0 |
|
Gram 1 |
1 | 0.3 | 0 | 0 | 0 | 0 |
239 exposures with major (1), moderate (10), or minor/minimal medical outcomes (228) did not report a substance quantity ingested.
Two exposures reportedly ingested 60 ml of alcohol-based hand sanitizer and were aged 1 year (weight unspecified) and 4 years (15.9 kg).
Descriptor is used by American Association of Poison Control Centers for ingestions that are the result of a bite of a substance.
Substance formulation including solids was individually confirmed by the authors to be non-solid hand sanitizer products from product code names.
Only a few exposures required hospitalization, suggesting ingestion of small amounts of ABHS (i.e., taste/lick/drop) is fairly well-tolerated by children. However, increased access places children at higher risk of unintentional exposure and toxicity. Some ABHS resemble drink/food products, or contain colorful dyes and attractive scents, all of which may appeal to children.
In light of increased ABHS use during COVID-19, recent nationwide recalls of ABHS products contaminated with methanol, and published reports of methanol poisoning (i.e. death, visual impairment) following ingestion, educating caretakers regarding supervising children’s access to any ABHS (e.g., ethanol, isopropanol, methanol) is an important public health need [7,8]. In cases of exposure, caregivers should be advised to contact a PCC or seek medical attention immediately.
Acknowledgements
Authors thank S. Christopher Jones.
This work was authored as part of the Contributor’s official duties as an Employee of the United States Government and is therefore a work of the United States Government. In accordance with 17 USC. 105, no copyright protection is available for such works under US Law.
Footnotes
Disclosure statement
No potential conflict of interest was reported by the author(s).
The views expressed are those of the authors and not necessarily those of the U.S. Food and Drug Administration.
Contributor Information
Lynda McCulley, Division of Pharmacovigilance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Carmen Cheng, Division of Pharmacovigilance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Evelyn Mentari, Office of Nonprescription Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ida-Lina Diak, Division of Pharmacovigilance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Theresa Michele, Office of Nonprescription Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
References
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