Clinical Toxicology

ISSN: (Print) (Online) Journal homepage: https://www.tandfonline.com/loi/ictx20

Pediatric ingestions with gummy formulated

medications: a retrospective study

Erika Bishop Crawford , Teresa Coco , LaDonna Gaines , Nipam Shah & Ann
Slattery

To cite this article: Erika Bishop Crawford , Teresa Coco , LaDonna Gaines , Nipam Shah & Ann
Slattery (2020): Pediatric ingestions with gummy formulated medications: a retrospective study,
Clinical Toxicology, DOI: 10.1080/15563650.2020.1822532

To link to this article: https://doi.org/10.1080/15563650.2020.1822532

Published online: 06 Oct 2020.

Submit your article to this journal

View related articles

View Crossmark data

Full Terms & Conditions of access and use can be found at

https://www.tandfonline.com/action/journalInformation?journalCode=ictx20
CLINICAL TOXICOLOGY
https://doi.org/10.1080/15563650.2020.1822532

POISON CENTRE RESEARCH

Pediatric ingestions with gummy formulated medications: a retrospective study

Erika Bishop Crawforda,b, Teresa Cocoa,b, LaDonna Gainesb, Nipam Shaha,b and Ann Slatteryb
a
Pediatric Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; bChildren’s of Alabama, Birmingham, AL, USA

ABSTRACT ARTICLE HISTORY

Context: Gummy formulations are widely available with estimated 65% marketed for children. Received 8 May 2020
Currently, there are few studies describing children ingesting gummy formulated medications. The aim Revised 28 August 2020
of this study was to quantify and identify the type of ingestions due to gummy formulated medica- Accepted 4 September 2020
tions, evaluate their clinical significance as defined by adverse outcomes: associated symptoms, emer-
KEYWORDS
gency department (ED) visits, and hospitalizations. Pediatric; gummy
Methods: Retrospective study in children aged 0–19 exposed to gummy formulated medications from medication; ingestion;
2015 to 2017 as identified by calls made to the Regional Poison Control Center (RPCC). A list of poten- poisonings; retrospective
tially toxic gummy formulated medications was compiled and reviewed by medical and clinical toxicol- cohort
ogists. We categorized medications into vitamins, minerals and supplements, melatonin, and other.
Data collected included: medication name, number of units, age, sex, symptoms described, ED visit,
hospitalization, and unintentional or intentional ingestion.
Discussion: Of the 66,059 pediatric exposures received by RPCC, 1143 (1.7%) involved gummy formu-
lated medications of which 1098 were analyzed. Median age was 3 years, 57.7% were males and 7%
were symptomatic. Seventy-four percent exposures involved vitamins and 24% melatonin. In compari-
son to other gummy exposures, those who ingested melatonin had 8.4 times higher odds of being
symptomatic (OR: 8.4, 95% CI: 5.1, 14) and 4.8 times higher odds of visiting ED (OR: 4.8, 95% CI: 2.5,
9). The predominant symptoms reported were drowsiness, gastrointestinal upset, and hyperactivity.
Two patients were hospitalized who ingested multiple medications, one was unintentional, and one
was intentional as a suicide attempt thus admitted for psychiatric stabilization.
Conclusions: Gummy formulated medications comprised <2% of the total pediatric calls to the RPCC.
Although, the occurrence of symptoms is rare, these medications especially those containing mela-
tonin should be safely stored.

Introduction Children are ingesting gummy formulated medications,

The American Association of Poison Control Centers pub-
lishes a National Poison Data System (NPDS) annual report
and in 2017 reported 1,265,052 exposures in children less
than 19 years of age [1]. Of the 999,529 children less than
6 years of age who ingested substances in 2017, 76,818
(7.69%) of exposures involved vitamins and dietary supple-
ments, which were among the top 10 most frequently
ingested substance categories in this age group [1].
Multivitamins and mineral supplements are widely available
as gummy, or a chewy-gelatinous based substance, formula-
tions with 65% marketed for children [2]. We performed a lit-
erature search using keywords such as “gummy”, “pediatric”,
“children”, “gelatin”, “glutinous”, “chewy”, “candy”,
“chewable”, and others. PubMed, Embase, and Cochrane
databases were searched. We found two case reports of
pediatric gummy medication ingestion. The first detailed
ventricular tachycardia following the ingestion of
Hydroxycut# weight loss gummies in a teenage female and
the second described observed angioedema and urticaria fol-
lowing ingestion of a gummy candy in a school aged
male [3,4].
given this we hypothesized there might be some potentially
toxic ingestions that are clinically important in this patient
population. The main objective of this study was to assess
the proportion of children ingesting gummy formulated
medications and identify the common types of ingestions.
Secondarily, we also wanted to assess the clinical significance
of these ingestions by the number of adverse events in this
patient population as defined by the presence of symptoms,
emergency department (ED) visits and hospitalization.
Materials and methods
Study design and setting
The Regional Poison Control Center (RPCC) is a statewide
poison center that provides rapid poison information to prac-
titioners, caregivers, and patients of all ages open 24 h,
seven days a week and 365 days a year. The RPCC is a fully
accredited poison center by the American Association of
Poison Control Centers and is the only accredited statewide
center designated by the Alabama Department of Public
Health [5]. Children’s of Alabama (COA) is a freestanding,

CONTACT Erika Bishop Crawford erika.bishop1988@gmail.com 1600 7th Avenue South, Children’s Park Place, Suite #110, Birmingham 35233, AL, USA
ß 2020 Informa UK Limited, trading as Taylor & Francis Group
2 E. B. CRAWFORD ET AL.
tertiary care center for pediatric and pediatric subspecialty
care. In 2018, COA served patients from 42 other states and
seven countries with about 15,000 hospitalizations and more
than 670,000 outpatient visits. This was a single-center retro-
spective cohort study that was reviewed and approved by
the University of Alabama at Birmingham’s Institutional
Review Board, a single institutional review board that reviews
and approves adult as well as pediatric studies.
Study population and list of gummy formulated
medications
Children aged 0–19 years exposed to gummy formulated
medications during the 3-year period from 1 January 2015 to
31 December 2017 as identified by calls to the RPCC, which
is designated as the sole poison center by the state of
Alabama, were included in the study. An online search
was conducted using key words such as “vitamins”,
“supplements”, “minerals”, “gummies”, “gummy”, and
“gummy formulations” to identify the available over-the-
counter medications in gummy formulation. A list of poten-
tially toxic gummy formulated medications was compiled
from those commercially available. Both clinical and medical
toxicologists reviewed this list independently and a final list
was derived upon consensus. The medications (generic
codes) included were: multivitamins (047971), prenatal vita-
mins with and without iron (023970), calcium (152000), vita-
min C (047973), vitamin D3 (046000), co-enzyme Q10
(201109, 077920), niacin (047975), vitamin B6 (047976), mela-
tonin (201106), immune complex (vitamins A, C, D3, and E
with zinc) (201099), iron (023000, 201129, 023972), caffeine
(084000), cannabidiol (310146), and Hydroxycut# weight loss
products (084000, 201116). THC edibles were not specifically
included in this study.
Data abstraction and analysis
The RPCC used toxiCALLV at the time of this study as their
R
electronic medical record (EMR). Also, at the time of this
study, a separate formulation designation of “gummy” did
not exist in their EMR. As described above a list of commer-
cially available products was compiled. A Clinical Toxicologist
at RPCC created a query to pull all pediatric cases
(0–19 years) with the NPDS generic codes (listed above) for
the study period. This search yielded 2220 cases. Each case
narrative was read for the description of the product. There
were 1143 cases where the formulation type of the product
was identified as gummy or gummies. Data variables col-
lected from the RPCC database in the defined study period
included: ingested medication name, number of units
believed to have been ingested, age, sex, presence of symp-
toms (symptomatic or asymptomatic), ED visit, hospitaliza-
tion, symptoms described, unintentional versus intentional
ingestion, and medical record number if applicable. In this
study, an unintentional ingestion was defined by either an
ingestion by a child less than 6 years of age as these inges-
tions tend to be exploratory in nature and/or defined by the
caregivers’ understanding of the child’s or the participant’s
own account of the intent of the ingestion when reported to
the RPCC. Also, the Centers for Disease Control and
Prevention defines unintentional poisonings as occurring
“when a person taking or giving too much of a substance
did not mean to cause harm” [6]. This definition would also
include an unintentional therapeutic error by a caregiver
where too much of a medication, an incorrect medication,
etc. was given to a child.
The data abstractor reviewed the charts to extract the
required information. Reported symptoms were collected at
the time of the call and were recorded through free text.
Patients’ medical record number was utilized to correlate the
RPCC database with our institution’s EMR. This was done in
the event that patients were referred and presented to our
ED in order to further describe their symptoms and admis-
sion if applicable. To ensure data quality, a second abstractor
was utilized to review 135 (12%) randomly selected charts
and inter-rater reliability was calculated for the variable
“presence of symptoms”. Inter-rater reliability was found to
be 97%. The data abstractors were not blinded to the study’s
objective.
For the purposes of data analysis, the list of medications
was classified into four categories: vitamins, minerals and
supplements, melatonin, and other. A dietary supplement is
intended to supplement one’s diet and may include a vita-
min, mineral, herb, amino acid, concentrate, metabolite, con-
stituent, extract, or any dietary substance [7]. Therefore,
vitamins are a type of supplement that contain organic com-
pounds that are essential to one’s health [8]. Prenatal and
multivitamins with and without iron were classified as vita-
mins. Any combination medication was also classified as a
vitamin. It was also documented if ingestions included mul-
tiple medications and if symptoms were likely not related to
the reported ingestion which was determined by the record-
ing RPCC’s Clinical Toxicologist. We categorized age into
three age groups: those less than 6 years of age, those
6–12 years of age and those 13–19 years of age. We also
categorized age into those less than or equal to 12 years
and those greater than 12 years to compare exposure status,
presence of symptoms and if there was an ED visit. Data ana-
lysis was performed by using descriptive statistics for fre-
quencies and proportions and binary logistic regression was
used to calculate odds ratio and 95% confidence interval (CI).
Results
During the study period, there were 66,059 pediatric calls to
the RPCC. There were 2220 pediatric exposures of the prod-
uct codes included in our study. One thousand one hundred
and forty-three of those involved gummy formulated medi-
cations, which was 1.7% of total pediatric exposures in the
study period. Forty-five cases (3.9%) were excluded due to
missing data and 1098 cases were included in the analysis
(Figure 1). Five of these ingestions were due to polysub-
stance ingestions, all of which were referred to the ED. One
case was symptomatic at the time of the call but asymptom-
atic by the time of arrival to our institution’s ED. Two of the
polysubstance ingestions including the previously
 CLINICAL TOXICOLOGY 3

66,059 comparing younger children (12 years of age) to adoles-

Total pediatric exposures to the
RPCC during study period
2,220
Exposures to product codes included
in this study (gummy and non-
gummy formulations)
45 Excluded
1,143 - 43 missing data on number of tablets
Gummy ingested
medication - 2 missing data on age, symptoms,
ingestion calls unintentional vs intentional, ED visit
and/or hospitalization
1,098
Calls included in the
analysis
932 (84.9%)
Unintentional
77 (7%)
Presence of
Symptoms
41 (3.7%)
ED Visit
2 (0.2%)
Hospitalization
Figure 1. Flowchart demonstrating volume of calls to RCCC due to pediatric
gummy formulation medication ingestion and outcome of those calls.
symptomatic case were seen at our institution and were
admitted, which are detailed later in this section. The median
age was 3 years (IQR ¼ 3) and 57.7% of the study population
was male. Eight hundred and fourteen (74.1%) ingestions
involved gummy vitamins, 265 (24.1%) involved gummy
melatonin, four (0.4%) involved minerals and supplements in
gummy form and the remaining 15 (1.4%) ingestions
involved other gummy substances. Of all the gummy medi-
cation ingestions, these ingestions were more common in
children less than 6 years of age when compared to those
6–12 years (82% vs.16%; percentage difference ¼ 66%; 95%
CI of difference: 62.8%, 69.1%). Similarly, these ingestions
were more common in those less than 6 years of age when
compared to those greater than 12 years (82% vs. 2%; per-
centage difference ¼ 80%; 95% CI of difference: 78%, 83%).
A large proportion of gummy medication ingestions (85%)
were unintentional in nature. Of those who ingested gummy
medications, 77 (7%) were symptomatic, 41 (3.7%) resulted
in an ED visit, and two cases were hospitalized.
Of all the unintentional ingestions reported by the care-
giver at the time of initial call to the RPCC, the proportion of
unintentional cases was higher in the less than 6 years of
age category than the other age categories. When
cent (>12 years of age), the proportion of unintentional
ingestions in younger children were significantly higher (86%
vs. 42%; percentage difference ¼ 44%; 95% CI of difference:
20%, 64%) and intentional ingestions were significantly
higher in adolescents (58% vs. 14%; percentage difference ¼
44%; 95% CI of difference: 22%, 66%) when comparing each
to their counterpart, respectively. This pattern is the same as
previously reported in other pediatric poisonings. There was
no statistically significant difference between the age catego-
ries in those that were symptomatic and had ED visits (Table
1). Also, when comparing the proportions of unintentional
versus intentional exposures that were symptomatic, these
were almost similar (7% vs. 7.2%).
The presence of symptoms was statistically significantly
higher in those ingesting medications containing melatonin
than those ingesting vitamins (20% vs. 2.9%; percentage dif-
ference ¼ 17.1%; 95% CI of difference: 13.7%, 20.5%). In
comparison to the other gummy exposures, those who
ingested melatonin had 8.4 times higher odds of being
symptomatic (OR: 8.4, 95% CI: 5.1, 14). Similarly, proportion
of ED visits were statistically significantly higher in those
ingesting medications containing melatonin than those
ingesting vitamins (9.1% vs. 2.1%; percentage difference ¼
7.1%; 95% CI of difference: 3.4%, 10.1%). In comparison to
the other gummy exposures, those who ingested melatonin
had 4.8 times higher odds of visiting the ED (OR: 4.8, 95% CI:
2.5, 9) (Table 2). The predominant symptoms reported were
drowsiness, gastrointestinal upset which included either nau-
sea, vomiting, diarrhea and/or abdominal pain, and hyper-
activity. Other symptoms reported included slurred speech,
confusion, tachycardia, tachypnea, and increased appetite.
Of the 41 cases that resulted in ED visits, seven presented
to our institution’s ED and two were admitted to our hos-
pital. Description of these seven patients is shown in Table 3.
The other 34 cases that were referred by the RPCC to be
evaluated in the ED but did not present to our institution’s
ED therefore further details regarding those ingestions is
unknown. Due to the retrospective nature of the study, fol-
low-up data on the other cases that were not seen in our
institution were unavailable for review. Of the study’s cases,
two were admitted to our institution’s hospital. Both were
polyingestions who were admitted for reasons not related to
the gummy medication ingestion; one due to observation for
potential side effects related to the co-ingestants and the
other due to the need of inpatient psychiatric stabilization.
Discussion
We found that of the total pediatric calls to the Alabama
RPCC during the study period about 1.7% were for gummy
formulated medication ingestions and these were most com-
mon in younger children and males. Most of the gummy
medication ingestions involved gummy vitamins and were
unintentional exposures. The occurrence of symptoms from
gummy formulated medications ingestions is rare with less
than 4% resulting in ED visits. Melatonin ingestions, however,
were statistically significantly more associated with having
4 E. B. CRAWFORD ET AL.

Table 1. Characteristics and Outcomes of calls to RPCC due to gummy formulation medication ingestions by age categories.
Young (12 years) Adolescent (>12 years) Percentage
Characteristic/outcome (N ¼ 1079) (N ¼ 19) difference 95% CI of the difference
Unintentional exposures, n (%) 924 (86) 8 (42) 44% 20%, 64%
Intentional exposures, n (%) 155 (14) 11 (58) 44% 22%, 66%
Presence of symptoms, n (%) 76 (7.0) 1 (5.3) 1.7% –8.5%, 11.9%
ED visit, n (%) 39 (3.6) 2 (10.5) 6.9% –6.8%, 20.6%
RPCC: Regional Poison Control Center; CI: confidence interval; ED: emergency department.
Bolded values represent statistical significance.

Table 2. Odds ratio with 95% CI of each characteristic/outcome for melatonin gummies.
Melatonin gummies (reference: other gummies)
Characteristic/outcome OR (95% CI)
Unintentional exposures (ref: intentional exposures) 1.46 (0.96, 2.22)
Intentional exposures (ref: unintentional exposures) 0.69 (0.45, 1.04)
Presence of symptoms (ref: no symptoms) 8.4 (5.1, 14.0)
ED visit (ref: no ED visit) 4.8 (2.5, 9.0)
OR: odds ratio; CI: confidence interval; ED: emergency department.
Bolded values represent statistical significance.

Table 3. Patients presenting to Children’s of Alabama Emergency Department after gummy medication ingestion.
Intentional or
Age Sex Medication ingested # of tablets unintentional Symptoms Disposition
17 months F MVI (with losartan and metformin) 1 (1, 2–3) U No symptoms Admitted
19 months F Melatonin 5 mg 14 U Drowsiness DC
23 months M Melatonin 5 mg 10–15 U Drowsiness Observation for 2 h, DC
3 years M Melatonin 5 mg 30 U No symptoms Observation for 2 h, DC
3 years M PNV 5 U No symptoms DC
13 years F PNV, (B12, Advil) Unknown I No symptoms Admitted for psychiatric treatment
4 years F MVI 50–56 U Abdominal pain DC
F: female; M: male; MVI: multivitamin; PNV: prenatal vitamins; U: unintentional; I: intentional; DC: discharged home.

symptoms and resulting in ED visits than those of the other
medication categories. The most common symptoms of
melatonin ingestions were drowsiness and gastrointestinal
upset. This was also demonstrated in our small cohort of
patients seen in our institution’s ED. At the time of the study,
the unintentional referral dose for a melatonin ingestion was
>80 mg or symptomatic. However, now the RPCC observes
any unintentional amount of melatonin ingested at home for
2 h unless the patient is more than just slightly drowsy.
The most common ingestion involved vitamins, this is
likely due to the fact that they are commonly available and
not considered to be potentially hazardous by adults there-
fore may not be securely stored. Ingestions are common in
those less than 6 years of age, which is thought to be due
to their oral exploration and curiosity at this stage of devel-
opment. Some gummy formulated medications also resem-
ble and can taste like candy or similar treats.
In addition to this being the first study to examine
gummy ingestions in children, the overall volume of calls to
the RPCC and thus cases included is a strength of our study.
Limitations of this study include that is a single center study.
Also, although we included cannabidiol gummy medications
in our list, we did not capture any instances of its ingestion
during our study period. It is likely that due to its increased
production, availability, and varying regulatory laws across
different states, reports of ingestions of this substance by
pediatric patients are higher in other poison centers and
states. We suspect there may be different results if the study
were expanded to a national or even international level. In
addition, the RPCC’s database did not previously list
medication by its type of formulation therefore our data
abstraction involved first identifying a medication by product
code then reviewing each case for gummy formulation. This
may have resulted in not abstracting all the potential cases
during the study period. Following completion of this study,
the RPCC has transitioned to another database and now are
able to query it by medication formulation. Also, querying
both our local and other poison control centers for all
gummy formulated medications, not just those available
over the counter, may demonstrate more potentially toxic
and thus clinically important ingestions in the pediatric
population. Although the list of gummy formulated medica-
tions was developed and reviewed by both medical and clin-
ical toxicologists, there could have been gummy medications
that may not have been included in this list. Also, given the
lack of a universal EMR in the state of Alabama, we were
unable to completely track those patients who presented to
another ED and thus could not comment further on those
visits and their dispositions.
Conclusions
Reports of gummy formulated medication ingestions in the
pediatric patient population are not commonly made to the
RPCC. Furthermore, those requiring healthcare evaluation
and stabilization are even less rare. Without more studies it
is difficult to conclude the true clinical significance of
gummy medication ingestions in the pediatric population.
Based on our study’s findings, we support that those con-
taining melatonin should be safely stored with child-resistant

closures to prevent symptomatic ingestions potentially utiliz-
ing further healthcare resources.
Acknowledgements
Dr. Michele H. Nichols, professor in Pediatric Emergency Medicine and
medical toxicologist at Children’s of Alabama, for reviewing our list of
potentially toxic commercially available over-the-counter gummy formu-
lated medications.
Disclosure statement
The authors report no conflict of interest.
References
[1] Gummin DD, Mowry JB, Spyker DA, et al. 2017 Annual Report of
the American Association of Poison Control Centers’ National
Poison Data System (NPDS): 35th Annual Report. Clin Toxicol.
2018;21:1–203.
CLINICAL TOXICOLOGY 5
[2] Olivo L. Focus on gummy supplements. Nutraceuticals world;
2017; [cited 2017 Jun 29]. Available from: https://www.nutraceuti-
calsworld.com/contents/view_online-exclusives/2017-06-29/focus-
on-gummy-supplements/
[3] Hammond DA, Thano E, Bohnenberger K, et al. Ventricular tachy-
cardia precipitated by the use of the diet supplement hydroxycut
gummies. Hosp Pharm. 2015;50(7):615–618.
[4] Anderson WC, Stukus D. Angioedema and urticaria following
ingestion of gummy candy: a case report. Ann Allergy Asthma
Immunol. 2010;105(5):A56–A57.
[5] Regional Poison Control Center. Children’s of Alabama 2018
annual report; 2019; [cited 2019 Feb 18]. Available from: http://
www.childrensal.org/rpcc
[6] Poisoning. Centers for Disease Control and Prevention, National
Center for Injury Prevention and Control; 2020; [cited 2020 Aug
10]. Available from: https://www.cdc.gov/homeandrecreationalsaf-
ety/poisoning/index.html
[7] Questions and Answers on Dietary Supplements. U.S. Food &
Drug Administration; 2020; [cited 2020 Jun 11]. Available from:
https://www.fda.gov/food/information-consumers-using-dietary-
supplements/questions-and-answers-dietary-supplements
[8] The Nutrition Source. Harvard T. H. Chan, School of Public Health;
2020; [cited 2020 Jun 11]. Available from: https://www.hsph.har-
vard.edu/nutritionsource/vitamins/