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Slone Survey
Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. Mitchell
Pediatrics 2008;122;e323
DOI: 10.1542/peds.2008-0498
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/122/2/e323.full.html
ARTICLE
Pediatric OTC CCMs are readily available in the United States and are widely promoted
for the treatment of childrens upper respiratory tract infections. Recent reports have
linked these products to serious adverse effects and deaths among children.
This study documents the prevalence and patterns of use of CCMs among US children
and provides a baseline against which to measure any changes in use that occur as a
result of marketing or regulatory actions.
ABSTRACT
OBJECTIVE. Pediatric cough and cold medications are widely marketed in the United States,
but the precise patterns of use among children are not known. Such information is
especially important given recent reports suggesting that these medications are responsible for previously underappreciated serious adverse events and deaths among children.
We sought to describe the prevalence and patterns of pediatric use of cough and cold
medications, with particular attention to use among young children.
METHODS. We analyzed data on the use of cough and cold medications, defined as any
oral medication that contains 1 antitussive, decongestant, expectorant, and/or
first-generation antihistamine active ingredients, among 4267 US children who were
younger than 18 years and enrolled during 1999 2006 in the Slone Survey, a
national random-digit-dial telephone survey of medication use by the US population.
RESULTS. In a given week, a cough and cold medication was used by 10.1% of US
www.pediatrics.org/cgi/doi/10.1542/
peds.2008-0498
doi:10.1542/peds.2008-0498
Key Words
cough and cold medications,
over-the-counter medications
Abbreviations
CCM cough and cold medication
OTC over-the-counter
FDAFood and Drug Administration
CI condence interval
Accepted for publication Apr 16, 2008
Address correspondence to Louis Vernacchio,
EDIATRIC COUGH AND cold medications (CCMs), which typically include antitussives, decongestants, expectorants,
and/or first-generation antihistamines, are readily available over the counter (OTC) in the United States and are
widely promoted for the treatment of childrens upper respiratory tract infections. Many of these medications are also
approved for the treatment of allergic diseases and may be used for those conditions as well. Reports of adverse effects
that are associated with these products (particularly inadvertent overdose) have increased in recent years, especially
among very young children. For example, the Toxic Exposure Surveillance System documented nearly 90 000 calls
and 3 accidental deaths associated with CCM among US children in 2004,1 and 7000 annual emergency department
visits were attributed to CCM in a recent study.2 Among children who were younger than 2 years, the Centers for
Disease Control and Prevention linked CCMs to 1500 emergency department visits in 2004 2005 and 3 additional
deaths in 2005.3 The US Food and Drug Administration (FDA) recently enforced measures against unapproved
marketing of the antihistamine carbinoxamine to young children because of reports of 21 deaths that were associated
with use of this drug in children who were younger than 2 years.4 In a number of case series, CCM overdoses have
been linked to neurologic impairment, cardiovascular instability, and death among young children.59
Concerns about these toxicities, especially in light of data that CCMs have not been proved effective in treating
symptoms of cough and the common cold in young children,1016 led to the filing of a citizen petition with the FDA
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VERNACCHIO et al
use, and reason for use. For children who were younger
than 14 years, a parent/guardian was interviewed; for
children who were 14 to 17 years of age, either the child
or a parent/guardian was interviewed (82.2% of interviews in this age range were completed by a parent/
guardian). The study was approved by the Boston University Medical Campus Institutional Review Board.
This analysis used data derived from all individuals
who were younger than 18 years for the complete years
1999 2006. We included in the analysis all oral medications, both OTC and prescription, that contained 1
antitussive, decongestant, expectorant, or first-generation antihistamine active ingredients (we excluded firstgeneration antihistamines such as dimenhydrinate and
cyproheptadine that do not carry an indication for the
common cold). Response rates were calculated according to the American Association for Public Opinion Research RR3 definition.25 Estimates of the weekly prevalences of use were weighted by household size to adjust
for the probability of selection. Prevalence comparisons
were performed by 2 analysis. SAS 9.1 (SAS Institute,
Cary, NC) was used for all analyses.
RESULTS
The response rate to the survey during the period 1999
2006 was 61.9%, and 4267 individuals who were aged 0
to 17 years were enrolled. The median age was 9 years
(25th, 75th percentiles: 4, 13), and 48.9% were female
(both similar to the 2000 US census26). In terms of race/
ethnicity, 65.2% were white non-Hispanic (69.1%, census); 14.3% were Hispanic (12.5%, census); 11.7% were
black non-Hispanic (12.1%, census); 1.9% were Asian
non-Hispanic (3.6%, census); and 7.0% were of other,
mixed, or unknown race/ethnicity (2.7%, census). According to US census regions, 19.4% were from the
Northeast (18.0%, census), 25.9% from the South
(35.4%, census), 25.0% from the Midwest (23.1%, census), and 29.8% from the West (23.5%, census).
Of the 4267 children surveyed, 439 had used a CCM
in the previous week, for a weighted prevalence of use of
10.1% (95% confidence interval [CI]: 9.211.0). The
1-week prevalences of exposure to specific CCM active
ingredients are shown in Table 1; 4.1% of individuals
were exposed to antitussives (primarily dextromethorphan), 6.3% to decongestants (primarily pseudoephedrine), 1.5% to expectorants (nearly all guaifenesin), and
6.3% to a variety of first-generation antihistamines.
A summary of the 489 products used by the 439 study
subjects is shown in Table 2. Among those products, 175
(35.8%) were single-ingredient products, the most common of which were first-generation antihistamines
(19.4% of all products) and decongestants (7.2%). A total
of 314 (64.2%) products contained multiple active ingredients; those most commonly used were decongestant/
first-generation antihistamine combinations (15.5%) and
antitussive/decongestant/first-generation antihistamine
combinations (10.4%). Of note, 100 (20.4%) of the
CCM products also contained an analgesic (acetaminophen, in all but 7). We asked the reason for the use of
each medication, but many responses were not clearly
Weighted Prevalence,
% (95% CI)a
Any CCMb
Antitussives
Dextromethorphan
Codeine
Hydrocodone
Carbetapentane
Decongestants
Pseudoephedrine
Phenylpropanolamine
Phenylephrine
Expectorants
Guaifenesin
Guaiacolsulfate
First-generation antihistamines
Chlorpheniramine
Diphenhydramine
Brompheniramine
Doxylamine
Carbinoxamine
Pyrilamine
Promethazine
Hydroxyzine
Phenyltoxamine
Triprolidine
Pheniramine
Dexbrompheniramine
Phenindamine
439
174
161
8
4
1
278
214
53
21
68
67
1
271
99
83
50
14
10
9
8
5
4
3
2
1
1
10.1 (9.211.0)
4.1 (3.54.7)
3.8 (3.24.4)
0.2 (0.10.4)
0.1 (0.00.2)
0.0 (0.00.1)
6.3 (5.67.1)
4.9 (4.25.6)
1.1 (0.81.4)
0.5 (0.30.7)
1.5 (1.11.9)
1.5 (1.11.8)
0.0 (0.00.1)
6.3 (5.57.0)
2.2 (1.82.6)
2.0 (1.52.4)
1.1 (0.81.5)
0.4 (0.20.6)
0.3 (0.10.4)
0.2 (0.10.3)
0.2 (0.00.3)
0.1 (0.00.2)
0.1 (0.00.2)
0.1 (0.00.1)
0.1 (0.00.1)
0.0 (0.00.1)
0.0 (0.00.1)
a Weighted
b Dened
TABLE 2 List of 489 Cough and Cold Product Types Used by 439 Study Subjects
Product Type
n (%) of All
Products
First-generation antihistamine
Decongestant rst-generation antihistamine
Antitussive decongestant rst-generation antihistamine
Antitussive decongestant rst-generation antihistamine analgesic
Decongestant
Antitussive expectorant
Decongestant analgesic
Antitussive
Expectorant
Decongestant second-generation antihistamineb
Antitussive decongestant
Decongestant rst-generation antihistamine analgesic
Antitussive decongestant analgesic
Antitussive decongestant expectorant
First-generation antihistamine analgesic
Decongestant expectorant
Antitussive rst-generation antihistamine
Antitussive analgesic
Antitussive decongestant expectorant analgesic
Antitussive decongestant expectorant rst-generation antihistamine
Expectorant rst-generation antihistamine
95 (19.4)
76 (15.5)
51 (10.4)
36 (7.4)
35 (7.2)
28 (5.7)
24 (4.9)
23 (4.7)
22 (4.5)
20 (4.1)
18 (3.7)
17 (3.5)
9 (1.8)
8 (1.6)
8 (1.6)
7 (1.4)
4 (0.8)
4 (0.8)
2 (0.4)
1 (0.2)
1 (0.2)
Cold
Allergy
Other
4
15
21
10
1
22
2
10
11
0
7
1
2
5
0
2
2
0
0
0
1
3
25
14
13
8
2
7
6
6
1
8
4
6
0
0
0
2
0
1
0
0
52
15
3
0
3
1
1
0
0
17
0
3
0
0
0
0
0
0
0
1
0
36
21
13
13
23
3
14
7
5
2
3
9
1
3
8
5
0
4
1
0
0
a Reason for use was reported by the patient or parent; other includes responses that were not specically related to cough, cold, or allergy (eg, sleep, pain), or were difcult to classify specically
(eg, runny nose, congestion, sinus).
b Indicated for allergic diseases only, not common cold.
e325
100%
2.7%
2.7%
0.7%
7.6%
Other/unknowna
Tablet/capsule
Liquid
2.3%
0.7%
90%
33.8%
80%
70%
74.4%
60%
50%
94.6%
91.7%
40%
65.4%
30%
20%
23.3%
10%
0%
<2 y
25 y
611 y
1217 y
FIGURE 1
Form of cough and cold products used by children, stratied according to age group.
congestants, and expectorants each were used less frequently in the summer and more frequently in the winter (data not shown).
We examined the overall use of CCM stratified by the
childs gender and race/ethnicity, parental education,
household income, census region, and household size
and found no appreciable differences (data not shown),
except for a borderline higher prevalence of use among
individuals from the South and Midwest compared with
the Northeast (odds ratio for South: 1.5 [95% CI: 1.1
2.0]; odds ratio for Midwest: 1.5 [95% CI: 1.12.0]).
We also examined the duration of use of CCMs on at
least 1 day per week among study subjects. As shown in
Fig 4, the majority of CCM use was for 1 week. For
antitussives and expectorants, 15% of use was for 1 to
4 weeks, with virtually no use lasting 4 weeks. In
contrast, 22.9% of first-generation antihistamine use
was for 1 week (including 12.2% for 4 weeks), and
12%
Under 2 years
2-5 years
10%
6-11 years
12-17 years
8%
6%
4%
2%
0%
Antitussives
Decongestants
Expectorants
First-generation
antihistamines
FIGURE 2
Prevalence of exposure to antitussive, decongestant, expectorant, and rst-generation antihistamine active ingredients according to age group. Bars represent 95% CIs.
e326
VERNACCHIO et al
14%
12%
Any cough/cold
medication
Antitussives
10%
8%
FIGURE 3
Prevalence of exposure to any CCM and specic active
ingredients according to 2-year intervals.
Decongestants
6%
Expectorants
4%
First-generation
antihistamines
2%
0%
1999-2000
14 wk,
14.3%
14 wk,
12.1%
1 wk,
77.5%
1 wk,
84.6%
14 wk,
10.8%
14 wk,
14.9%
1 wk,
77.1%
1 wk,
83.6%
FIGURE 4
Duration of use on at least 1 day per week for antitussive (A), decongestant (B), expectorant (C), and rst-generation antihistamine (D) active ingredients.
2001-2002
2003-2004
2005-2006
e327
VERNACCHIO et al
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
e329
Cough and Cold Medication Use by US Children, 19992006: Results From the
Slone Survey
Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. Mitchell
Pediatrics 2008;122;e323
DOI: 10.1542/peds.2008-0498
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Services
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