In the wake of widespread dissemination of an FDA advisory and warnings that OTC cough and cold medications are dangerous for infants and children under two years of age, many pediatricians and parents reported they were less likely to use these products. However, our data suggest that parents were not convinced that these products are dangerous. While fewer than twenty percent of parents of children under two years old articulated that they will continue to use these products, parent’s confidence in their safety and efficacy together with their continued availability in the home suggest more widespread use is likely. These findings are similar to those from a national survey conducted in the fall of 2008, prior to the advisory,8
suggesting that the FDA advisory may have relatively little impact on parent behavior.
Pediatricians are parents most trusted source of information about drug safety and effectiveness.8
As no effective, safe treatments are available to provide symptomatic relief for children with coughs and colds, maybe it is time for physicians to recommend “non-treatment” -- avoidance of remedies that are unlikely to offer benefit, while ensuring adequate hydration and the treatment of fever when necessary. One dose of buckwheat honey at bedtime may reduce nocturnal cough frequency and improve sleep, 9
but honey is not recommended for infants less than one year old because of the risk of botulism.10
high dose vitamin C 14
and herbal medicines15
have not been shown to offer benefit. Prevention of URIs through breastfeeding16
and frequent hand-washing17
could also be promoted.
We were surprised that one in five parents reported they were more likely to request an antibiotic for symptom relief after the advisory. It is possible that parent’s interpreted the phrase “request an antibiotic” to mean “make sure an antibiotic is not required.” Pediatricians identified the lack of parent education materials as a potential barrier to implementation of the FDA advisory, but resources to support avoidance of antibiotic treatment for a URI are available free of charge at http://www.cdc.gov
. Although controversial, watchful waiting is recommended for some children with uncomplicated acute otitis media and acute sinusitis,18–20
is common practice in some European countries,21, 22
and is an acceptable approach for many U.S. parents.23
Providing information about judicious antibiotic use during well child visits may lessen expectations for antibiotic treatment when a URI occurs.
Our data suggest that the voluntary recall of products marketed for infants and children under two years old is unlikely to reduce the availability of products at home. Similarly, the recent action by members of the Consumer Healthcare Products Association (CHPA) to re-label products as “do not use” in children under four years old is unlikely to reduce availability.24
Accidental ingestion is the most common cause of emergency department visits for adverse drug events related to OTC cough and cold medications,1
and it is worrisome that products continue to be available in most homes. A recommendation by the FDA to avoid use of these products in older children and adults would likely reduce availability in the home, but introduction of child-resistant packaging proposed by CHPA manufacturers may be a more effective strategy to reduce accidental ingestion.1
There are several limitations to this study. While our response rate of 53% for the physician survey was comparable to other physician surveys, and our estimate of the response rate for the parent survey is robust (~ 77%), it is possible that non-response bias may have affected our results. Similarly, although our sample of parents was large, the study population was primarily suburban, caucasian and non-medicaid and our findings may not be generalizable to other populations. As the physician survey was anonymous, we cannot assess how many of the pediatricians at the participating offices had completed the physician survey, nor can we link the physician and parent responses. Relying on self-reported data may have resulted in an overestimate of perceived desired behaviors such as reducing the use of OTC cough and cold medications, but other FDA warnings to avoid drugs because of safety concerns have decreased use in the targeted population.25
Only 73% of parents answered the question about having OTC in the home, which may reduce the accuracy of this estimate.
Physicians and parents are aware of the recent FDA warnings and advisory about avoidance of OTC cough and cold medications for infants and children under two years of age. Although most parents intend to avoid these products for their very young children, few agree they are dangerous, and many continue to believe they provide symptom relief and keep them at home. To avoid use of these and other alternative treatments that offer no benefit and incur cost, physicians should consider promoting “non-treatment” of children with URIs except for management of fever and dehydration as necessary.