Pediatric cough and cold products make headlines again

Over-the-counter cough/cold products for children have been a common theme in the Pharmacology Consult column in past years for a variety of reasons — issues related to availability and regulation, efficacy and safety, and misuse by caregivers, among others.

By definition, OTC products are available to consumers without a visit to, or discussion with, a prescribing clinician. Although these products are primarily found in pharmacies but also nonhealth commercial establishments, they can also be purchased without first consulting a pharmacist. These and other issues have introduced considerable controversy into the use of pediatric OTC cough/cold products. Recently, additional published studies have shed more light on their use.

Recent changes

The past 3 years have seen considerable change in the availability and use of pediatric OTC cough/cold products. In 2007, a citizen petition describing a lack of efficacy data and safety concerns in infants and children prompted the FDA to review the availability of these products. Also in 2007, manufacturers voluntarily withdrew products intended for use in children younger than 2 years from the commercial market. The following year, the FDA issued a public health advisory that agreed with this change, and manufacturers additionally changed OTC cough/cold product labels to state that they are not for use in children younger than 4 years. The FDA is continuing to review the labeling and availability of cough/cold products in children.

In 2009, the FDA and manufacturers of pediatric OTC liquid products issued separate voluntary guidelines for the packaging, use and labeling of these products, with the intent to improve their appropriate use, including dosing and administration. These guidelines are intended to improve the ability of caregivers to interpret product packaging and labeling and to accurately determine, measure and administer an appropriate dose of medication to a child.

Recent studies

Data have recently been published describing packaging and dosing inconsistencies in many currently available pediatric OTC products. Yin and colleagues (see related story on page 12) sought to determine the prevalence of inconsistent dosing directions and measuring devices among pediatric liquid OTC products and to compare this information with newly issued guidelines from the FDA. Liquid OTC products (analgesic, cough/cold, allergy, gastrointestinal) with labeling for children younger than 12 years were evaluated for availability of a product dosing device, labeled dosing directions, and dosing device measurements and abbreviations used. Differences in these areas among the products were assessed.

A total of 200 products, representing 99% of the US market share, were included in the analysis. Nearly half (45%) of the products studied were labeled for cough/cold use. Measuring devices were not included in 26% of these liquid products evaluated. Seventy-four percent of products contained a dosing device, including dosing cups (83.1%), droppers (13.5%) and syringes (2.7%). Of the products that included a liquid measuring device (148/200), inconsistencies between the products’ dosing directions and markings on the dosing device were found in nearly all products (98.6%).

Examples of these inconsistencies included missing markings and superfluous markings. Some products used units of measurement that caregivers may not be familiar with, such as “drams” or “cc.” If readers do not recall a dram, it is equivalent to one-eighth of an ounce (approximately 3.7 mL). The unit of liquid measurement most commonly used by the evaluated products included teaspoon (77.5%), milliliter (71.5%) and tablespoon (18.5%). Of the products that included an abbreviation, 163 did not define at least one abbreviation.

Other published studies have evaluated the effects of the recent commercial market withdrawal of cough/cold products for children younger than 2 years. Researchers from the CDC sought to evaluate adverse effects from cough/cold product (OTC and prescription) use among children after market withdrawal (Shehab and colleagues; see related story on page 20).

Using a nationally representative sample of 63 US EDs, ED visits among children younger than 12 years related to use of cough/cold products were compared in 14-month study periods before and after product withdrawal. For the study period after cough/cold product withdrawal, the numbers and proportions of national extrapolated ED visits for adverse effects due to cough/cold product use in children younger than 2 years were reduced by 55%. The overall number of visits because of cough/cold product use in all children younger than 12 years, however, did not differ between the two study periods, as many ingestions continued to occur in children aged 2 to 5 years. Most ingestions (68%) during both study periods were categorized as unsupervised ingestions.

Use, dangers of cough/cold products

OTC products intended for use in children for symptoms of respiratory tract infections are commonly available and heavily advertised. Data indicate that these products are widely used. The Sloan Survey, a random-digit telephone survey of recent prescription and OTC medication use among children younger than 12 years (1998-2007), revealed that ingredients commonly found in cough/cold products were among the most frequently used in all age groups. In a given week, the number of children who received OTC medications was more than twice that of children who received prescription medications.

Other data have described caregivers’ intentions for use of pediatric OTC cough/cold products after the withdrawal of products for young children in 2007. One study surveyed caregivers (n=179) in a pediatric clinic in early 2008, several months after the withdrawal of OTC cough/cold products for children younger than 2 years (Yaghmai). Caregivers were shown four OTC cough/cold products and were asked if they had and would continue to give these products to their child, and if so, what dose would they administer. Of the caregivers familiar with the 2007 withdrawal, 23.9% and 40.6% with children younger than 2 years and aged 2 to 5 years, respectively, said they would continue to use OTC cough/cold products.

Continued use

When asked what dose they would administer to their child (when allowed to examine the product packaging), 65.4% and 41.7% stated an inappropriate dose for children younger than 2 years and aged 2 to 5 years, respectively. Of 33 pediatricians surveyed, 30% reported recommending OTC cough/cold products for children younger than 6 years.

A nationally representative survey of 572 parents with children younger than 6 years was conducted in November 2007, just after the withdrawal of OTC cough/cold products for children younger than 2 years. Although product withdrawal had occurred just before this survey, most parents said they continued to believe that pediatric OTC cough/cold products were safe and effective for children younger than 2 years (64% and 66%, respectively) and aged 2 to 5 years (81% and 78%, respectively).

When asked if they would continue to give OTC cough/cold products to their children, 20% and 30% of parents with children younger than 2 years and aged 2 to 5 years, respectively, said they would. Of surveyed caregivers, 45% and 64% reported that their physicians had recommended these products for children younger than 2 years and aged 2 to 5 years, respectively.

Changes in the availability of pediatric OTC cough/cold products have occurred because of lack of efficacy data and concerns over the safety of these products. Several published reports have described the dangers of cough/cold products in children. Dart and colleagues recently examined several data sources for information on fatalities of children younger than 12 years potentially associated with cough/cold product administration. Of 189 cases examined, 118 were judged to be possibly, likely or definitely related to a cough/cold product use. Of these, 103 involved use of an OTC product, with overdosing of the product potentially associated with 88 cases. Contributing factors included age younger than 2 years; use of medication for sedation; use in a day care setting; use of two products with the same ingredient; failure to use a measuring device; product misidentification; and use of an adult OTC product.

Conclusions

Despite the removal of some products from the commercial market, some data indicate that parents may continue to give currently available pediatric products to young children, believing that they are safe and effective.

New proposed recommendations may improve product use. Much published data have shown that parents and caregivers commonly make mistakes when using pediatric OTC cough/cold products, including dose determination, dose measurement and selection of an appropriate product.

As clinicians, what can we do? Perhaps most important, clinicians can focus on these issues when providing care to young children with respiratory tract symptoms and take time to discuss these concerns with caregivers, including easy availability and use of OTC products, lack of efficacy data, dosing and dose measurement and safety concerns. Don’t assume that parents are not using these products, and if they are, don’t assume that they are administering them appropriately.

Edward A. Bell, PharmD, BCPS, is a Professor of Clinical Sciences at Drake University College of Pharmacy, Blank Children’s Hospital and Clinics in Des Moines, Iowa.

Disclosure: Bell has no direct financial interest in any of the products mentioned in this article nor is he a paid consultant for any companies mentioned.

For more information:

• Dart RC. Ann Emerg Med. 2009;53:411-417.
• Klein-Schwartz W. Pharmacoepidemiol Drug Saf. 2010;19:819-824.
• National Public Radio, Kaiser Family Foundation, Harvard School of Public Health. Children’s OTC medicines: the public, and parents, weigh in. 2007. Available at: www.kff.org/kaiserpolls/upload/7726.pdf.
• Rimsza ME. Pediatrics. 2008;122:e318-322.
• Shehab N. Pediatrics. 2010;126:1100-1107.
• Vernacchio L. Pediatrics. 2009;124:446-454.
• Yaghmai BF. Clin Pediatr (Phila). 2010;49:310-315.
• Yin HS. JAMA. 2010;304:2595-2602.