DOI: 10.1542/peds.2008-0498 2008;122;e323Pediatrics

Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. MitchellSlone Survey

2006: Results From the−Cough and Cold Medication Use by US Children, 1999  

  http://pediatrics.aappublications.org/content/122/2/e323.full.html

located on the World Wide Web at: The online version of this article, along with updated information and services, is

 

of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2008 by the American Academy published, and trademarked by the American Academy of Pediatrics, 141 Northwest Pointpublication, it has been published continuously since 1948. PEDIATRICS is owned, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

ARTICLE

Cough and Cold Medication Use by US Children,1999–2006: Results From the Slone SurveyLouis Vernacchio, MD, MSc, Judith P. Kelly, MS, David W. Kaufman, ScD, Allen A. Mitchell, MD

Slone Epidemiology Center, Boston University, Boston, Massachusetts

Financial Disclosure: The analyses presented in this article were funded internally by the Slone Epidemiology Center at Boston University; the center has received funding from McNeil Consumer Healthcare forother analyses related to the pediatric use of cough and cold medications.

What’s Known on This Subject

Pediatric OTC CCMs are readily available in the United States and are widely promotedfor the treatment of children’s upper respiratory tract infections. Recent reports havelinked these products to serious adverse effects and deaths among children.

What This Study Adds

This study documents the prevalence and patterns of use of CCMs among US childrenand provides a baseline against which to measure any changes in use that occur as aresult 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 isespecially important given recent reports suggesting that these medications are respon-sible for previously underappreciated serious adverse events and deaths among children.We sought to describe the prevalence and patterns of pediatric use of cough and coldmedications, with particular attention to use among young children.

METHODS.We analyzed data on the use of cough and cold medications, defined as anyoral medication that contains �1 antitussive, decongestant, expectorant, and/orfirst-generation antihistamine active ingredients, among 4267 US children who wereyounger than 18 years and enrolled during 1999–2006 in the Slone Survey, anational 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 USchildren. Exposure was highest to decongestants (6.3%; mostly pseudoephedrine)and first-generation antihistamines (6.3%; most common were chlorpheniramine,diphenhydramine, and brompheniramine), followed by antitussives (4.1%; mostlydextromethorphan) and expectorants (1.5%; almost exclusively guaifenesin). Mul-tiple-ingredient products accounted for 64.2% of all cough and cold medicationsused. Exposure to antitussives, decongestants, and first-generation antihistamineswas highest among 2- to 5-year-olds (7.0%, 9.9%, and 10.1%, respectively) followed by children who were youngerthan 2 years (5.9%, 9.4%, and 7.6%, respectively); expectorant use was low in all age groups. The use of cough andcold medications declined from 1999 through 2006.

CONCLUSIONS.Approximately 1 in 10 US children uses a cough and cold medication in a given week. The especially highprevalence of use among children of young age is noteworthy, given concerns about potential adverse effects and thelack of data on the efficacy of cough and cold medications in this age group. Pediatrics 2008;122:e323–e329

PEDIATRIC 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 children’s upper respiratory tract infections. Many of these medications are alsoapproved for the treatment of allergic diseases and may be used for those conditions as well. Reports of adverse effectsthat are associated with these products (particularly inadvertent overdose) have increased in recent years, especiallyamong very young children. For example, the Toxic Exposure Surveillance System documented nearly 90 000 callsand 3 accidental deaths associated with CCM among US children in 2004,1 and �7000 annual emergency departmentvisits were attributed to CCM in a recent study.2 Among children who were younger than 2 years, the Centers forDisease Control and Prevention linked CCMs to �1500 emergency department visits in 2004–2005 and 3 additionaldeaths in 2005.3 The US Food and Drug Administration (FDA) recently enforced measures against unapprovedmarketing of the antihistamine carbinoxamine to young children because of reports of 21 deaths that were associatedwith use of this drug in children who were younger than 2 years.4 In a number of case series, CCM overdoses havebeen linked to neurologic impairment, cardiovascular instability, and death among young children.5–9

Concerns about these toxicities, especially in light of data that CCMs have not been proved effective in treatingsymptoms of cough and the common cold in young children,10–16 led to the filing of a citizen petition with the FDA

www.pediatrics.org/cgi/doi/10.1542/peds.2008-0498

doi:10.1542/peds.2008-0498

KeyWordscough and cold medications,over-the-counter medications

AbbreviationsCCM—cough and cold medicationOTC—over-the-counterFDA—Food and Drug AdministrationCI—confidence interval

Accepted for publication Apr 16, 2008

Address correspondence to Louis Vernacchio,MD, Slone Epidemiology Center at BostonUniversity, 1010 Commonwealth Ave, Boston,MA 02115. E-mail: lvernacchio@slone.bu.edu

PEDIATRICS (ISSN Numbers: Print, 0031-4005;Online, 1098-4275). Copyright © 2008 by theAmerican Academy of Pediatrics

PEDIATRICS Volume 122, Number 2, August 2008 e323 at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

on March 1, 2007,17 which prompted an FDA review ofthe safety and efficacy of CCMs for children. In October2007, the Consumer Healthcare Products Associationannounced a voluntary withdrawal of “infant” coughand cold preparations targeted to children who areyounger than 2 years.18 In the meantime, the FDA’sNonprescription Drugs and Pediatric Advisory commit-tees voted to ban OTC CCMs that are intended for chil-dren who are younger than 6 years,19 and the FDA iscurrently considering the committees’ advice.

Although the potential for harm has been docu-mented, understanding the risks of CCMs to childrenrequires information on the prevalence and patterns ofuse of these medications. It is difficult, however, to iden-tify usage patterns for what are primarily OTC products.Unlike prescription drugs, purchases of OTC medicationsare not captured in insurance and pharmacy claims data;in addition, data on patterns of exposure can be obtainedonly directly from patients or their parents. As a result,very few data exist on the prevalence and patterns ofCCM use among children. One US study from 1994,relying on interview data from the Longitudinal Fol-low-up to the National Maternal and Infant Health Sur-vey, found that approximately one third of 3-year-oldchildren had used an OTC CCM within the previous 30days,20 and a 2007 study from England based on mailsurvey data from the Avon Longitudinal Study of Par-ents and Children identified use of CCMs in the previousyear by two thirds of children 3.0 to 4.5 years of age andby approximately half of children 5.5 to 7.5 years ofage.21 A national telephone survey conducted in Novem-ber 2007 reported that 56% of parents of children whowere younger than 2 and 79% of parents of childrenwho were aged 2 to 6 years had ever given their childrena CCM, but no additional information on types of prod-ucts or patterns of use was collected22; therefore, tocharacterize the current prevalence and patterns of useof CCMs by US children and to provide a baseline againstwhich to measure any changes in use that occur as aresult of marketing and regulatory actions, we analyzeddata from the Slone Survey, a random-digit-dial tele-phone survey of medication use among the US popula-tion.

METHODSDetailed methods of the Slone Survey have been pub-lished.23 Briefly, this random-digit-dial telephone surveytargeted households in the 48 contiguous states and theDistrict of Columbia and was conducted continuouslybetween February 1998 and April 2007. Once a house-hold was successfully contacted, 1 individual from thehousehold was randomly selected for interview and in-formed consent was obtained. All medication use (in-cluding prescription and OTC products, vitamins/miner-als, and herbals/supplements) by the selected individualwithin the past week was ascertained by structured in-terview. Medications were linked to their active ingre-dients through the Slone Epidemiology Center’s DrugDictionary.24 Details of use were obtained, includingdrug form (eg, tablet, liquid), duration and frequency of

use, and reason for use. For children who were youngerthan 14 years, a parent/guardian was interviewed; forchildren who were 14 to 17 years of age, either the childor a parent/guardian was interviewed (82.2% of inter-views in this age range were completed by a parent/guardian). The study was approved by the Boston Uni-versity Medical Campus Institutional Review Board.

This analysis used data derived from all individualswho were younger than 18 years for the complete years1999–2006. We included in the analysis all oral medi-cations, both OTC and prescription, that contained �1antitussive, decongestant, expectorant, or first-genera-tion antihistamine active ingredients (we excluded first-generation antihistamines such as dimenhydrinate andcyproheptadine that do not carry an indication for thecommon cold). Response rates were calculated accord-ing to the American Association for Public Opinion Re-search RR3 definition.25 Estimates of the weekly preva-lences of use were weighted by household size to adjustfor the probability of selection. Prevalence comparisonswere performed by �2 analysis. SAS 9.1 (SAS Institute,Cary, NC) was used for all analyses.

RESULTSThe response rate to the survey during the period 1999–2006 was 61.9%, and 4267 individuals who were aged 0to 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%, cen-sus); 14.3% were Hispanic (12.5%, census); 11.7% wereblack non-Hispanic (12.1%, census); 1.9% were Asiannon-Hispanic (3.6%, census); and 7.0% were of other,mixed, or unknown race/ethnicity (2.7%, census). Ac-cording to US census regions, 19.4% were from theNortheast (18.0%, census), 25.9% from the South(35.4%, census), 25.0% from the Midwest (23.1%, cen-sus), and 29.8% from the West (23.5%, census).

Of the 4267 children surveyed, 439 had used a CCMin the previous week, for a weighted prevalence of use of10.1% (95% confidence interval [CI]: 9.2–11.0). The1-week prevalences of exposure to specific CCM activeingredients are shown in Table 1; 4.1% of individualswere exposed to antitussives (primarily dextromethor-phan), 6.3% to decongestants (primarily pseudoephed-rine), 1.5% to expectorants (nearly all guaifenesin), and6.3% to a variety of first-generation antihistamines.

A summary of the 489 products used by the 439 studysubjects is shown in Table 2. Among those products, 175(35.8%) were single-ingredient products, the most com-mon of which were first-generation antihistamines(19.4% of all products) and decongestants (7.2%). A totalof 314 (64.2%) products contained multiple active ingre-dients; those most commonly used were decongestant/first-generation antihistamine combinations (15.5%) andantitussive/decongestant/first-generation antihistaminecombinations (10.4%). Of note, 100 (20.4%) of theCCM products also contained an analgesic (acetamino-phen, in all but 7). We asked the reason for the use ofeach medication, but many responses were not clearly

e324 VERNACCHIO et al at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

related to cough, cold, or allergy (eg, “sleep,” “pain”) orwere difficult to classify specifically (eg, “runny nose,”“congestion,” “sinus”). For the 489 products used, thestated reason for use was cough in 116 (23.7%); cold in106 (21.7%); allergy in 96 (19.6%); and not related tocough, cold, or allergy or unclear in 171 (35.0%). Theforms of the products used stratified by age are shown inFig 1. Among children who were younger than 2 years,94.6% were liquid preparations, a frequency that de-creased with age to 23.3% among adolescents.

The 1-week prevalences of use of specific active in-gredients stratified by age are shown in Fig 2. Exposureto antitussives, decongestants, and first-generation anti-histamines was highest among 2- to 5-year-olds (7.0%,9.9%, and 10.1%, respectively) followed by childrenwho were younger than 2 years (5.9%, 9.4%, and 7.6%,respectively). Expectorant use was relatively low in allage groups.

Among all ages combined, the 1-week prevalence ofuse of any CCM declined significantly throughout thecourse of the study, from a high of 12.3% in 1999–2000to a low of 8.4% in 2005–2006 (P � .003 for trend; Fig3). The prevalence of exposure to antitussive and expec-torant active ingredients did not change significantlyover time (P � .3 and P � .2 for trend, respectively). Incontrast, decongestant use declined from 7.2% in 1999–2000 to 5.1% in 2005–2006 (P � .03 for trend), with asteep decline in phenylpropanolamine use, from 2.8% in1999–2000 to 0.3% in 2005–2006 (P � .0001 for trend).In addition, first-generation antihistamine use declinedfrom 8.5% in 1999–2000 to 5.3% in 2005–2006 (P �.002 for trend). The use of antihistamines did not varysignificantly according to season, but antitussives, de-

TABLE 2 List of 489 Cough and Cold Product Types Used by 439 Study Subjects

Product Type n (%) of AllProducts

Reason for Usea

Cough Cold Allergy Other

First-generation antihistamine 95 (19.4) 4 3 52 36Decongestant � first-generation antihistamine 76 (15.5) 15 25 15 21Antitussive � decongestant � first-generation antihistamine 51 (10.4) 21 14 3 13Antitussive � decongestant � first-generation antihistamine � analgesic 36 (7.4) 10 13 0 13Decongestant 35 (7.2) 1 8 3 23Antitussive � expectorant 28 (5.7) 22 2 1 3Decongestant � analgesic 24 (4.9) 2 7 1 14Antitussive 23 (4.7) 10 6 0 7Expectorant 22 (4.5) 11 6 0 5Decongestant � second-generation antihistamineb 20 (4.1) 0 1 17 2Antitussive � decongestant 18 (3.7) 7 8 0 3Decongestant � first-generation antihistamine � analgesic 17 (3.5) 1 4 3 9Antitussive � decongestant � analgesic 9 (1.8) 2 6 0 1Antitussive � decongestant � expectorant 8 (1.6) 5 0 0 3First-generation antihistamine � analgesic 8 (1.6) 0 0 0 8Decongestant � expectorant 7 (1.4) 2 0 0 5Antitussive � first-generation antihistamine 4 (0.8) 2 2 0 0Antitussive � analgesic 4 (0.8) 0 0 0 4Antitussive � decongestant � expectorant � analgesic 2 (0.4) 0 1 0 1Antitussive � decongestant � expectorant � first-generation antihistamine 1 (0.2) 0 0 1 0Expectorant � first-generation antihistamine 1 (0.2) 1 0 0 0a Reason for usewas reportedby thepatient or parent; �other� includes responses thatwerenot specifically related to cough, cold, or allergy (eg, �sleep,� �pain�), orweredifficult to classify specifically(eg, �runny nose,� �congestion,� �sinus�).b Indicated for allergic diseases only, not common cold.

TABLE 1 One-Week Prevalence of Exposure to Any CCM, Categoriesof Active Ingredients, and Specific Active IngredientsAmong 4267 US Children: 1999–2006

Parameter n Weighted Prevalence,% (95% CI)a

Any CCMb 439 10.1 (9.2–11.0)Antitussives 174 4.1 (3.5–4.7)Dextromethorphan 161 3.8 (3.2–4.4)Codeine 8 0.2 (0.1–0.4)Hydrocodone 4 0.1 (0.0–0.2)Carbetapentane 1 0.0 (0.0–0.1)

Decongestants 278 6.3 (5.6–7.1)Pseudoephedrine 214 4.9 (4.2–5.6)Phenylpropanolamine 53 1.1 (0.8–1.4)Phenylephrine 21 0.5 (0.3–0.7)

Expectorants 68 1.5 (1.1–1.9)Guaifenesin 67 1.5 (1.1–1.8)Guaiacolsulfate 1 0.0 (0.0–0.1)

First-generation antihistamines 271 6.3 (5.5–7.0)Chlorpheniramine 99 2.2 (1.8–2.6)Diphenhydramine 83 2.0 (1.5–2.4)Brompheniramine 50 1.1 (0.8–1.5)Doxylamine 14 0.4 (0.2–0.6)Carbinoxamine 10 0.3 (0.1–0.4)Pyrilamine 9 0.2 (0.1–0.3)Promethazine 8 0.2 (0.0–0.3)Hydroxyzine 5 0.1 (0.0–0.2)Phenyltoxamine 4 0.1 (0.0–0.2)Triprolidine 3 0.1 (0.0–0.1)Pheniramine 2 0.1 (0.0–0.1)Dexbrompheniramine 1 0.0 (0.0–0.1)Phenindamine 1 0.0 (0.0–0.1)

a Weighted for household sizeb Defined as an oral medication that contains �1 antitussive, decongestant, expectorant, orfirst-generation antihistamine active ingredients.

PEDIATRICS Volume 122, Number 2, August 2008 e325 at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

congestants, and expectorants each were used less fre-quently in the summer and more frequently in the win-ter (data not shown).

We examined the overall use of CCM stratified by thechild’s gender and race/ethnicity, parental education,household income, census region, and household sizeand found no appreciable differences (data not shown),except for a borderline higher prevalence of use amongindividuals 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: 1.1–2.0]).

We also examined the duration of use of CCMs on atleast 1 day per week among study subjects. As shown inFig 4, the majority of CCM use was for �1 week. Forantitussives and expectorants, �15% of use was for 1 to4 weeks, with virtually no use lasting �4 weeks. Incontrast, 22.9% of first-generation antihistamine usewas for �1 week (including 12.2% for �4 weeks), and

94.6% 91.7%

65.4%

23.3%

2.7% 7.6%

33.8%

74.4%

2.7% 0.7% 0.7% 2.3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

<2 y 2–5 y 6–11 y 12–17 y

Other/unknowna

Tablet/capsuleLiquid

FIGURE 1Form of cough and cold products used by children, stratified according to age group.

0%

2%

4%

6%

8%

10%

12%

Antitussives Decongestants Expectorants First-generationantihistamines

Under 2 years

2-5 years

6-11 years

12-17 years

FIGURE 2Prevalence of exposure to antitussive, decongestant, expectorant, and first-generation antihistamine active ingredients according to age group. Bars represent 95% CIs.

e326 VERNACCHIO et al at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

22.5% of decongestant use was for �1 week (including10.4% for �4 weeks). Of the 56 individuals who used aCCM for �4 weeks, 22 used a first-generation antihis-tamine alone, 14 used a decongestant plus a second-generation antihistamine, and 9 used a decongestantplus a first-generation antihistamine; the majority tookthem on a daily basis. The reasons for using a CCM for�4 weeks included allergies in 37 (66.1%), sleep in 4(7.1%), cough in 2 (3.6%), cold in 1 (1.8%), and otherreasons in 12 (21.4%). Among those who took a CCMfor �4 weeks, there were 11 children who were youngerthan 6 years. Four of them used a first-generation anti-histamine alone; 4 used a decongestant plus first-gener-

ation antihistamine; and 1 each used a decongestantalone, a decongestant plus a second-generation antihis-tamine, and a first-generation antihistamine plus an an-algesic.

DISCUSSIONThis study documents that CCMs are used widely by USchildren for the treatment of coughs, colds, allergies, anda variety of other reasons, with �1 in 10 children, or justover 7 million individuals, exposed to at least 1 CCM ina given week. Our estimate of the weekly prevalence ofexposure is consistent with a monthly prevalence ofapproximately one third among 3-year-olds in the onlyother published US study to examine this issue.20 Wefound exposure to be particularly high among youngchildren, raising a potential safety concern becausenearly all published reports of CCM-associated seriousadverse events and deaths have involved very youngchildren.1,3–9 Although the high prevalence of use to-gether with the relatively small number of reported se-rious adverse events may suggest that the absolute mag-nitude of risk associated with pediatric CCM use is small,the important clinical and public health question iswhether any serious risk is justified by the benefits oftreatment. Despite widespread parental belief that pedi-atric CCMs are effective for treating coughs and colds,22

there are no data supporting the efficacy of CCMs forsuch uses in young children; the few available random-ized, controlled trials have found no significant benefitsin this age group.10–16

In addition to lack of evidence of efficacy for coughand the common cold, CCM use in young children isfraught with the potential for dosing errors. First, be-cause of the lack of clinical and pharmacologic studies ofchildren, most pediatric dosages are extrapolated fromadult data, and many CCMs lack formal dosing recom-mendations for young children.27,28 Second, concentra-tions and dosages for young children are not standard-ized across products, dosage delivery devices differ fromproduct to product, and products with different ingredi-

0%

2%

4%

6%

8%

10%

12%

14%

1999-2000 2001-2002 2003-2004 2005-2006

Any cough/coldmedicationAntitussives

Decongestants

Expectorants

First-generationantihistamines

FIGURE 3Prevalence of exposure to any CCM and specific activeingredients according to 2-year intervals.

≤1 wk, 84.6%

1–4 wk, 14.3%

>4 wk, 1.1%

≤1 wk, 77.5%

1–4 wk, 12.1%

>4 wk, 10.4%

≤1 wk, 83.6%

1–4 wk, 14.9%

>4 wk, 1.5%

≤1 wk, 77.1%

1–4 wk, 10.8%

>4 wk, 12.2%

A B

C D

FIGURE 4Duration of use on at least 1 day per week for antitussive (A), decongestant (B), expecto-rant (C), and first-generation antihistamine (D) active ingredients.

PEDIATRICS Volume 122, Number 2, August 2008 e327 at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

ents can have similar names. Finally, as our data pointout, well over half of pediatric CCM use involves mul-tiple-ingredient products (with as many as 5 separateactive ingredients), a situation that increases the risk fora child inadvertently receiving �1 product with thesame active ingredient.

The prevalence of use of any CCM among childrendeclined somewhat over the years of the study, with thedecline most notable for decongestants and first-gener-ation antihistamines. The decline in decongestant useseems largely attributable to the removal of phenylpro-panolamine from the market in 2000–2001 because ofits association with hemorrhagic stroke in adults.29 Wespeculate that pseudoephedrine use may likewise de-cline in the coming years as a result of the 2005 CombatMethamphetamine Act, which requires pseudoephed-rine-containing products to be kept behind pharmacycounters.30 More broad, the prevalence and patterns ofpediatric CCM use are likely to change substantiallygiven the media attention being paid to the issue of CCMsafety, the Consumer Healthcare Products Association’svoluntary recall of CCMs that are marketed for childrenwho are younger than 2 years,18 and any regulatorychanges that the FDA may make in response to its ad-visory panel’s recommendations. It will be important totrack secular trends in pediatric CCM use as thesechanges take effect.

Not surprising, we found that the duration of use ofCCMs varies substantially by components. Antitussivesand expectorants are used almost exclusively for briefperiods of time, whereas decongestants and first-gener-ation antihistamines are more commonly used for ex-tended durations. Most long-term use is for allergic dis-eases, and the predominant products used long-term areantihistamines or decongestant-antihistamine combina-tions, which are indicated for allergies as well as thecommon cold. Still, we identified a small number ofchildren, including a few who were younger than 6years, who were given other combination CCMs regu-larly for extended periods of time, and the risks that areassociated with such long-term exposure are unknown.

Our data suggest that CCM use is not strongly asso-ciated with personal and demographic factors such asgender, race/ethnicity, region, parental education,household income, or household size. That use is sowidespread among US children suggests that efforts fo-cused on educating the public about safe use of CCMsshould be broadly targeted.

Our study has several potential imitations. First, thereis the possibility of response bias. Although our responserate was relatively high for a random telephone surveyand our distributions of age, gender, and race/ethnicityapproximate the 2000 US census data, our sample some-what underrepresents children from the South andoverrepresents those from the West. We cannot deter-mine whether CCM exposure among nonresponders orundersampled populations differs from that of surveyparticipants. A second potential limitation is the accu-racy of the drug exposure information collected in thesurvey. We relied on parent (or patient) reports of prod-ucts used, but we made significant efforts to ensure that

such information was compete and accurate. Individualswere asked to gather all relevant bottles and packagesand to read medication names directly from the label;these were matched in real time to drug codes from theSlone Epidemiology Center Drug Dictionary, an elec-tronic compendium of prescription, OTC, vitamin, andherbal/supplement medications.24 Because only very re-cent use (within the previous 7 days) was elicited, thepossibility of recall errors was reduced. In most cases,parents acted as reporters of their children’s medicationuse, which may have led to underreporting of use inadolescents who may have obtained and used CCMsindependently. Finally, our survey was not designed tocapture illicit drug use or intentional misuse.

CONCLUSIONSThis study demonstrates that CCM use is commonamong US children despite a lack of demonstrated effi-cacy for treatment of cough and the common cold. Ofparticular concern are high rates of exposure amongyoung children, for whom dosing recommendations arelargely extrapolated from adults and the risk for adverseevents is greatest. Regulatory changes (which are cur-rently under consideration by the FDA) as well as effortsaimed at educating parents and caregivers about the safeuse of CCMs may be needed to reduce inappropriateexposure to these medications and thereby minimizerisks to children.

ACKNOWLEDGMENTS

We greatly appreciate the contributions of TheresaAnderson, study coordinator; Marie Berarducci andMarilyn Wasti, study supervisors; Gene Sun, informa-tion systems; and the interviewing staff.

REFERENCES1. Watson WA, Litovitz TL, Rodgers GC Jr, et al. 2004 Annual

report of the American Association of Poison Control CentersToxic Exposure Surveillance System. Am J Emerg Med. 2005;23(5):589–666

2. Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverseevents from cough and cold medications in children. Pediatrics.2008;121(4):783–787

3. Centers for Disease Control and Prevention. Infant deaths as-sociated with cough and cold medications: two states, 2005.MMWR Morb Mortal Wkly Rep. 2007;56(1):1–4

4. Shuren J. Carbinoxamine products: enforcement action dates.Fed Regist. 2006;71(111):33462–33465

5. Gadomski A, Horton L. The need for rational therapeutics inthe use of cough and cold medicine in infants. Pediatrics. 1992;89(4 pt 2):774–776

6. Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over-the-counter cough and cold medications. Pediatrics. 2001;108(3). Available at: www.pediatrics.org/cgi/content/full/108/3/e52

7. Marinetti L, Lehman L, Casto B, Harshbarger K, Kubiczek P,Davis J. Over-the-counter cold medications: postmortem find-ings in infants and the relationship to cause of death. J AnalToxicol. 2005;29(7):738–743

8. Wingert WE, Mundy LA, Collins GL, Chmara ES. Possible roleof pseudoephedrine and other over-the-counter cold medica-

e328 VERNACCHIO et al at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

tions in the deaths of very young children. J Forensic Sci. 2007;52(2):487–490

9. Boland DM, Rein J, Lew EO, Hearn WL. Fatal cold medicationintoxication in an infant. J Anal Toxicol. 2003;27(7):523–526

10. Sakchainanont B, Ruangkanchanasetr S, Chantarojanasiri T,Tapasart C, Suwanjutha S. Effectiveness of antihistamines incommon cold. J Med Assoc Thai. 1990;73(2):96–101

11. Hutton N, Wilson MH, Mellits ED, et al. Effectiveness of anantihistamine-decongestant combination for young childrenwith the common cold: a randomized, controlled clinical trial.J Pediatr. 1991;118(1):125–130

12. Korppi M, Laurikainen K, Pietikainen M, Silvasti M. Antitus-sives in the treatment of acute transient cough in children. ActaPaediatr Scand. 1991;80(10):969–971

13. Taylor JA, Novack AH, Almquist JR, Rogers JE. Efficacy ofcough suppressants in children. J Pediatr. 1993;122(5 pt 1):799–802

14. Clemens CJ, Taylor JA, Almquist JR, Quinn HC, Mehta A,Naylor GS. Is an antihistamine-decongestant combination ef-fective in temporarily relieving symptoms of the common coldin preschool children? J Pediatr. 1997;130(3):463–466

15. Paul IM, Yoder KE, Crowell KR, et al. Effect of dextrometho-rphan, diphenhydramine, and placebo on nocturnal cough andsleep quality for coughing children and their parents. Pediatrics.2004;114(1). Available at: www.pediatrics.org/cgi/content/full/114/1/e85

16. Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CMJr. Effect of honey, dextromethorphan, and no treatment onnocturnal cough and sleep quality for coughing children and theirparents. Arch Pediatr Adolesc Med. 2007;161(12):1140–1146

17. Public Health Advisory: Nonprescription Cough and Cold Med-icine Use in Children. Available at: www.fda.gov/cder/drug/advisory/cough�cold.htm. Accessed October 23, 2007

18. Consumer Healthcare Products Association. Makers of OTCcough and cold medicines announce voluntary withdrawal oforal infant medicines. Available at: www.chpa-info.org/ChpaPortal/PressRoom/NewsReleases/2007/10�11�07�CCMedicines.htm. Ac-cessed October 25, 2007

19. Joint Meeting of the Nonprescription Drugs Advisory Committee

and the Pediatric Advisory Committee October 18–19, 2007.Available at: www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4323m1-Final.pdf. Accessed December 20, 2007

20. Kogan MD, Pappas G, Yu SM, Kotelchuck M. Over-the-counter medication use among US preschool-age children.JAMA. 1994;272(13):1025–1030

21. Headley J, Northstone K. Medication administered to childrenfrom 0 to 7.5 years in the Avon Longitudinal Study of Parentsand Children (ALSPAC). Eur J Clin Pharmacol. 2007;63(2):189–195

22. Children’s OTC cold medicines: the public, and parents, weighin. Available at: www.kff.org/kaiserpolls/upload/7725.pdf. Ac-cessed February 14, 2008

23. Kaufman DW, Kelly JP, Rosenberg L, Anderson TE, MitchellAA. Recent patterns of medication use in the ambulatory adultpopulation of the United States: the Slone survey. JAMA. 2002;287(3):337–344

24. Kelley KE, Kelley TP, Kaufman DW, Mitchell AA. The SloneDrug Dictionary: a research driven pharmacoepidemiology tool[Abstract]. Pharmacoepidemiol Drug Saf. 2003;12(S1):S168–S169

25. American Association for Public Opinion Research. StandardDefinitions: Final Disposition of Case Codes and Outcome ResearchRates for Surveys. 3rd ed. Lenexa, KS: American Association forPublic Opinion Research; 2004

26. Census 2000 Gateway. Available at: www.census.gov/main/www/cen2000.html. Accessed November 30, 2007

27. Cold, cough, allergy, bronchodilator, and antiasthmatic drugproducts for over-the-counter human use. Fed Regist. 2002;67(246):78158–78172

28. Sharfstein JM, North M, Serwint JR. Over the counter but nolonger under the radar: pediatric cough and cold medications.N Engl J Med. 2007;357(23):2321–2324

29. Meadows M. FDA issues public health advisory on phenylpro-panolamine in drug products. FDA Consum. 2001;35(1):9

30. Retail sales of scheduled listed chemical products: self-certification of regulated sellers of scheduled listed chemicalproducts. Interim final rule with request for comment. FedRegist. 2006;71(186):56008–56027

PEDIATRICS Volume 122, Number 2, August 2008 e329 at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from

DOI: 10.1542/peds.2008-0498 2008;122;e323Pediatrics

Louis Vernacchio, Judith P. Kelly, David W. Kaufman and Allen A. MitchellSlone Survey

2006: Results From the−Cough and Cold Medication Use by US Children, 1999  

ServicesUpdated Information &

tmlhttp://pediatrics.aappublications.org/content/122/2/e323.full.hincluding high resolution figures, can be found at:

References

tml#ref-list-1http://pediatrics.aappublications.org/content/122/2/e323.full.hat:This article cites 22 articles, 4 of which can be accessed free

Citations

tml#related-urlshttp://pediatrics.aappublications.org/content/122/2/e323.full.hThis article has been cited by 4 HighWire-hosted articles:

Subspecialty Collections

s_and_toxicologyhttp://pediatrics.aappublications.org/cgi/collection/therapeuticTherapeutics & Toxicologythe following collection(s):This article, along with others on similar topics, appears in

Permissions & Licensing

mlhttp://pediatrics.aappublications.org/site/misc/Permissions.xhttables) or in its entirety can be found online at: Information about reproducing this article in parts (figures,

Reprints http://pediatrics.aappublications.org/site/misc/reprints.xhtml

Information about ordering reprints can be found online:

rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Grove Village, Illinois, 60007. Copyright © 2008 by the American Academy of Pediatrics. All and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elkpublication, it has been published continuously since 1948. PEDIATRICS is owned, published, PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly

at Indonesia:AAP Sponsored on December 23, 2012pediatrics.aappublications.orgDownloaded from