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 DOI: 10.1177/0009922813482761

2013 52: 534 originally published online 28 March 2013CLIN PEDIATRSarah Gard Lazarus, Steven L. Lanski, Ashley S. Smith and Harold K. Simon

Cold Preparation Use in Young Children After FDA Warnings: Do Concerns Still Exist?  

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Clinical Pediatrics52(6) 534 –539© The Author(s) 2013Reprints and permissions: sagepub.com/journalsPermissions.navDOI: 10.1177/0009922813482761cpj.sagepub.com

Article

BackgroundCough medications are often defined as any oral medi-cation containing more than 1 antihistamine, deconges-tant, expectorant, or antitussive.1 The active ingredients in these cough medicines are commonly pseudoephed-rine, diphenhydramine, doxylamine, and phenyleph-rine.2 Potential side effects include cardiac arrhythmias from decongestants, hallucinations from antihista-mines, and altered levels of consciousness from anti-tussives.3 Pseudoephedrine is the ingredient linked to the most number of deaths.2 In a recent study, 118/189 possible deaths in children younger than 12 were felt to be related to the side effects of cough and cold medica-tions. Approximately 7000 children are treated in emer-gency departments each year for secondary side effects of cough medications.4 The main reasons patients experience toxicity from these medications include receiving too much medication, receiving medication too frequently, or receiving multiple cough medications containing the same ingredient.1

Cough and cold medication use continues despite evidence showing that they are not effective. Since

1985, several randomized controlled over-the-counter (OTC) trials have been conducted, which compared cough and cold medicines with placebos in children younger than 12 years. All showed little clinical advan-tage of cough and cold medication use over placebos.3 A 2008 Cochrane review explored 8 studies with 616 chil-dren and found “no good evidence of effectiveness of OTC medicines in acute cough.”5 Trials have also shown that dextromethorphan and diphenhydramine are not effective in quieting cough. In addition, these trials dem-onstrated that cough medicines do not improve sleep. However, according to estimates (prior to new FDA

482761 CPJXXX10.1177/0009922813482761Clinical PediatricsLazarus et al

1Department of Pediatrics, Emory University, Atlanta, GA, USA2Children’s Healthcare of Atlanta, Divison of Pediatric Emergency Medicine, Atlanta, GA, USA3Regional Children’s Hospital at Providence, El Paso, TX, USA4Department of Emergency Medicine, Emory University

Corresponding Author:Sarah Gard Lazarus, Department of Pediatrics, Emory University, 1645 Tullie Circle, Atlanta, GA 30329, USA. Email: sagard@emory.edu

Cold Preparation Use in Young Children After FDA Warnings: Do Concerns Still Exist?

Sarah Gard Lazarus, DO1, Steven L. Lanski, MD1, 2, 3, 4, Ashley S. Smith, MPH2, and Harold K. Simon, MD, MBA1, 2, 4

Abstract

Objective. To characterize the use and delivery of cough and cold medicines in children younger than 6 presenting to an inner-city pediatric emergency department (PED) following 2007 FDA warnings. Methods. A cross-sectional observational study was performed using a convenience sampling of PED patients during the fall of 2010. Caregivers were presented with 6 commonly used cough medicine preparations and were asked to demonstrate if and how they would administer these to their children. Results. In all, 65 patients and their caregivers consented and participated in the study. During the demonstration, 82% (53/65) stated that they would treat with cough or cold medicines, and 72% (38/53) incorrectly dosed the medication they desired to give. Conclusions. Despite current recommendations, cough and cold medicines are still used in children younger than 6 years of age. A significant portion of caregivers report that they are still unaware of public warnings, potential side effects, and interactions with other medications.

Keywords

cough, emergency medicine, over-the-counter (OTC), parenting education

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warnings), approximately one-third of all 3-year-olds may receive cough medicine in any given month.1 According to the report by Vernacchio et al6 in the Slone Survey, 10% of surveyed households (4200 children younger than 18 years old) used cough syrup in any given week.

In March 2007, a citizen petition was submitted to the FDA because of concerns about the safety of cough medications in children younger than 6 years of age. In October 2007, the Consumer Healthcare Products Association announced a voluntary withdrawal of “infant” cough and cold preparations targeted at chil-dren younger than 2 years of age. In October 2008, the FDA’s Nonprescription Drugs and Pediatric Advisory committees voted against the marketing of OTC cough and cold medications intended for children who are younger than 6 years of age.7

Despite the FDA’s recommendations, manufacturers have continued to market these products to children younger than 6 years of age. The highest use of these medications is among children 2 to 5 years old.8 These medications are usually given by caregivers for per-ceived symptomatic relief of coughs, colds, and aller-gies in their children. Parents also have difficulty with dosing and delivering these and other OTCs.8 Also, concentrations and dosing regimens are not standard-ized.6 In addition, these medications as well as other nonprescription medications can have deleterious side effects.9

Multiple investigations have shown that there is lit-tle clinical advantage between the use of placebos and cold and cough medicines in young children. In fact, adverse events may outweigh any benefits, and this led the FDA in 2008 to recommend that they not be used in young children. However, limited data exist on present use since the FDA recommendation. Therefore, this study set out to explore the use of cold and cough medi-cations in a small sample of pediatric emergency department (PED) patients. In addition, this study explores the reported recommendation practices of physicians and health care providers regarding cough and cold medications.

MethodsAfter approval by the Emory University Institutional Review Board, a convenience sample of participants was recruited from 2 emergency rooms under the Children’s Healthcare of Atlanta System between September and October 2010. Children and their care-givers were eligible if the children were (a) younger than 6 years of age with a presenting complaint of cold or cough symptoms, (b) parents or legal guardians were

present and older than 18 years of age, and (c) parents could read and sign the consent form. The children were excluded from the study if they had signs of respiratory distress (tachypnea, retractions, wheezing, or stridor) or were deemed otherwise unstable by the triage nurse or investigator.

In the dosing and knowledge demonstration, the par-ent or caregiver was presented with a box of 6 com-monly used cough or cold preparations available in local drug or grocery stores. The following preparations were used: (a) Children’s Triaminic Night-time Cold and Cough time (phenylephrine HCL 2.5 mg + diphenhydr-amine 6.25 mg); (b) Mucinex for Kids Expectorant and Nasal Decongestant Liquid Mixed Berry (Guinifenesin 100 mg and phenylephrine HCl 2.5 mg); (c) Dimetapp Children’s Cold and Allergy, Kroger’s Brand (brom-pheniramine maleate 1 mg, phenylephrine 2.5 mg); (d) Little Noses Sterile Saline Nasal Mist (NaCl 0.9%); (e) Honey (Kroger’s Brand); and (f) Echinacea 400 mg (Figure 1). These preparations were randomly selected from popular cough medications, and they are easily available to the general public. They did not require pharmacist approval or a consumer signature. The par-ent or caregiver was asked which of these medications, if any, they would give to their children for their present-ing symptoms and how they would dose this medica-tion. Presented with the medications were several measuring devices, including a teaspoon, a tablespoon, and the measuring cups that came with the medications. This represented commonly used calibrated and non-calibrated measuring devices. Although the caregivers demonstrated measuring of the medications, they were not actually given to the patients.

After completing the demonstration portion, the investigator administered a 20-question survey (Table 1). The first part of the survey asked about demographics of the parent and child, past medical history of the child, current medications used by the child, and

Figure 1. Cough and cold preparations used in the demonstration.

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536 Clinical Pediatrics 52(6)

Table 1. Survey Given to Parents.

Survey questions for parents 1. Demographics: (State age in months up to 36 months, State age in years past 3) A. Child 1A. Age: 2A. Sex: 3A. Race: 4A. Education level: B. Parent 1B. Age: 2B. Sex: 3B. Race: 4B. Education level: 2. Past medical history of your child: Please circle which of the following your child has ever had: A. Asthma/Reactive airway disease/Wheezing B. Sickle cell or other blood problems C. Heart problems D. Cancer or other tumors E. NICU: neonatal intensive care unit or special care unit and why F. Seizures (febrile vs other) G. Behavioral problems: H. Other: (please write in)____________________________________ 3. Current prescription and nonprescription medications your child is taking: 4. Symptoms in the past month? (Circle all that apply) A. Cough B. Difficulty breathing C. Runny nose D. Congestion E. Wheezing F. Vomiting G. Ear pain/pulling on ears H. Diarrhea (loose stools more than 5×/day) I. Irritability/excessive crying J. Constipation (no stool in 3 days) K. Tremors L. Seizures M. Loss of consciousness N. Fever 6. Have you used cough or cold medicine for your child in the past six months? If so what was the name and the medication? 7. If you used the cough medication how much was given and how often? How long did you use it for? 8. If you used cough and cold medications, did you find them effective? A. Yes B. No 9. What symptoms were you using the cough and cold medications for?10. Was a cough and cold medicine recommended by someone? A. Yes B. No11. If yes, who? Circle all that apply: A. Doctor B. Pharmacist C. Friend D. Family E. Healthcare provider (specify) _______ F. Media (newspaper, TV)

(continued)

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presenting symptoms. The second section of questions were related to how often the child took cough and cold medications, potential side effects seen with these med-ications, potential interactions between this class of medications and other medications, parents’ awareness of current warnings related to cough and cold medica-tions, and whether anyone had recommended cough or cold medications to them. Finally, parents underwent a 2-paragraph scripted educational debriefing discuss-ing current recommendations for cough and cold medi-cations. The survey was designed and beta tested by the investigative team representing pediatricians, parents, and emergency physicians.

ResultsA total of 65 patients and their caregivers consented and participated in the study (mean patient age, 22 months; range, 3 weeks to 5 years). Demographically, 89% of the population surveyed was African American, 7% Caucasian, and 2% Asian, and 2% classified themselves as being of mixed race (Figure 2). Of the caregivers, 18% (12/65) had not completed high school, whereas 80% (52/65) had completed more than 12 years of edu-cation.

During the demonstration, 82% (53/65) stated they would treat with cough medicines and medicines; 70%

of caregivers (37/53) chose medicines containing phen-ylephrine, and 31/53 (58%) caregivers dosed medica-tions inappropriately per dosing recommendation labels in spite of having the bottles with associated instructions readily available. The majority of dosing errors that were made involved giving these medications to chil-dren who were younger than the labeled recommended age for the product. Also, 34% (18/53) of caregivers who stated they would treat with cough or cold medica-tions chose more than 1 medication.

Among caregivers, 20% (13/65) reported having received recommendations to give cough medications by health care providers. Of the other 13 health care pro-viders who reportedly recommended cough medicines, 6 were pediatricians, 4 were nonpediatric physicians, 1 was a nurse, and 2 were pharmacists. Interestingly, 92% (12/13) of the caregivers who received the recommen-dation to give cough medications by a health care pro-fessional chose to do so in the demonstration. Overall, 40% (25/65) of caregivers reported giving cough medi-cines to their children within the past 6 months. Of care-givers who reported receiving recommendations from health care providers, 69% (9/13) had given cough med-ications within the past 6 months. Of the patients who had been incorrectly dosed per new FDA warnings (23/53), 43% reported having used more than 1 cough medicine in the past 6 months.

G. Internet H. Other______12. To your knowledge, do cough and cold medicines have any harmful side effects? A. Yes B. No13. If yes, state which ones you’re aware of?14. To your knowledge, do cough and cold medications interact with any other medications? A. Yes B. No15. If so, which ones?16. To your knowledge, are you aware of any warnings against the use of cough or cold medications? A. Yes B. No17. If yes, what?18. If you have used cough and cold medications in the past for your child, would you use them again? A. Yes B. No19. In the past six months has your child used any home remedies or herbal medication? A. Yes B. No20. If yes, what are they?

Table 1. (continued)

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538 Clinical Pediatrics 52(6)

Also, 70% (45/65) of the parents surveyed were unaware that cough medications could have side effects, and 72% (47/65) reported being unaware of potential interactions with other medications. Only 46% (30/65) of caregivers reported being aware of warnings related to cold and cough medicines.

DiscussionCough medicines are commonly used in pediatric medicine. There have been multiple studies reporting that cough and cold medications are ineffective, and in many cases, potentially dangerous. Despite recommen-dations against cough and cold medications, the major-ity of caregivers in this investigation, when presented with the opportunity to give them, chose to treat, most

commonly with those containing phenylephrine. More than half of all caregivers, when asked to demonstrate their use of these medications, went against dosing rec-ommendation labels and incorrectly dosed these medi-cations in spite of having calibrated measuring devices and instruction labels readily available on the bottles. Of interest, the majority of the caregivers were edu-cated, having completed more than 12 years of school. Many of the children receiving these medications in our survey had comorbidities, including asthma, sickle cell disease, and heart problems requiring other medica-tions, making the use of these medications even more disconcerting and potentially hazardous. Furthermore, the majority of the caregivers had a poor understanding of potential side effects or interactions related to cough and cold medications. Of particular concern, health care

Figure 2. Number of patients given medication and percentage of patients by race.

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Lazarus et al 539

providers, including pediatricians, reportedly continue to recommend the use of cough and cold medications, despite the lack of evidence related to efficacy and warnings related to their use in young children. In this study, the perceived and reported recommendation to use these medications made by a medical professional seems to influence caregivers to give these medications.

LimitationsThe study population was a small convenience sample focused on a single population (one utilizing a PED), and the conclusions may not be fully generalizable. However, it does represent one of the most vulnerable populations and demonstrates that the general concern still exists regarding knowledge, dosing, and use of these medications that are no longer recommended for use in young children. It also explores caregiver self-reporting of what their health care providers have told them. Although parental report may not reflect the actual instructions, it does demonstrate the most impor-tant end point: caregiver perception and practice. There is also the possibility of recall bias regarding cough or cold medication use over the past 6-month period. However, a high rate of use was noted, and recall bias would tend to underestimate rather than overestimate use. The study also represented only a brief period of time during the cold and flu season when cough and cold preparations are typically of most importance to families. Repeating the study over a different period of time or time of year may change some of the data but would be unlikely to eliminate the overall concern or general patterns of use of cough and cold medicines.

ConclusionDespite current recommendations, cough and cold med-icines are still used in children younger than 6 years of age. In this sampling, a significant portion of caregivers report still being unaware of public warnings, potential side effects, and interactions with other medications. Actual dosing of medications and following labeling and dosing of these items are also of concern. According to these families, there are health care providers who con-tinue to recommend cough and cold medications, and these recommendations appear to have an impact on parental perception regarding use. Clearly, in this and

potentially the broader pediatric population, more educa-tion is necessary to fully translate present FDA and other recommendations into parental knowledge and practice.

Authors’ Note

Presented in part at Pediatric Academic Societies Annual Meeting on May 2, 2011, in Denver, Colorado.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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