Coughs, Colds, Children, and Over-the-Counter Remedies

Howard Markel, MD, PhD

Disclosures

April 05, 2007

A front-page story in the March 2, 2007 edition of The New York Times set off a wave of huzzahs from children's health professionals and a great deal of concern among American parents. Beneath the headline "U.S. Reviewing Safety of Children's Cough Drugs" was a lengthy account describing how a team of federal drug regulators, led by Dr. Charles J. Ganley, the Director of the Office of Nonprescription Drug Products at the US Food and Drug Administration (FDA), has begun a broad review of the safety, risks, and benefits of popular cold and cough remedies meant for children.[1]

It's about time.

Pediatricians have long complained about the potential risk for the plethora of cough syrups, cold remedies, and other nostrums containing nasal decongestants, antihistamines, cough suppressants, and expectorants. These medications are sold over-the-counter and are frequently given to children as young as 2 years old. Most alarmingly, a recent study of hospital emergency department cases seen between 2004 and 2005, conducted by the US Centers for Disease Control and Prevention, found that at least 1519 children under 2 years of age experienced serious health problems after being dosed with common cough medicines and remedies.[2]

One of the major problems observed was overdose of the nasal decongestant, pseudoephedrine, which can play a role in causing arrhythmias and, in particularly high doses, hypertension and stroke. There are also concerns about other common cold remedy ingredients, such as dextromethorphan, guaifenesin, and phenylephrine.

When a small child is miserable with fever, cough, congestion, and runny nose, the overwhelming majority of parents (myself included) want to do something to "make the monster go away." Many of these nostrums have the so-called "benefit" of inducing sleep in a suffering toddler because of the addition of antihistamines and even alcohol. However, when you consider that the average child suffers 6-10 colds a year -- a number far greater than healthy adults -- the risks for overdoses, incorrect doses, and adverse drug events only increase. Experts estimate every month that more than one third of all American 3-year-olds were given an over-the-counter cold or cough medication.

Sales of these widely advertised products are enormous. According to the Consumers Healthcare Products Association, in the United States during 2005, these products generated more than $3.5 billion worth of sales.[3] However, a growing portion of this huge market is directed at children. With names, such as Infant Triaminic, Toddler's Dimetapp, and Little Colds, these products come in brightly colored packaging and are sold in a wide menu of delectable flavors from old-time standards, such as grape and cherry, to the more exotic pina colada and tropical fruit punch.

The conventional wisdom is that these remedies might suppress coughs or "un-stuff" a stuffy nose for a short period of time, although there are a growing number of studies in children that find no significant difference in symptomatic relief when compared with placeboes. More troubling is that despite their wide use and sales, there is simply no good evidence to suggest that these agents do anything to actually cure colds or coughs.

Fortunately, a group of pediatricians and public health professionals, led by Dr. Joshua Sharfstein, the Commissioner of the Baltimore City Health Department, formally petitioned the FDA to look into the matter. Although these -- and virtually all doctors -- acknowledge that cough and cold remedies in recommended doses are generally safe, there is a mounting concern about the risks for overdoses and the potential for adverse drug interactions that can result when taking more than 1 of these medications.[4] In 2006, the American College of Chest Physicians issued a recommendation that parents avoid all cough and cold medicines in children, particularly those under 2 years of age.

Drug manufacturers typically take the stand that precautions are clearly marked on the labels of their products, and all parents are strongly encouraged to consult their physician before giving any over-the-counter medication to their children, especially those under the age of 2 years. However, one hardly has to practice pediatrics for more than a few weeks to know that parents in the middle of the night who are desperate to relieve their child's suffering often do give these syrups and medications to toddlers. Unfortunately, good intentions can lead to some serious problems for some children -- all in the course of giving a medication that probably does little or nothing.

There is much work to be done by the FDA and others who study the interactions and potential risks for these medications. However, a good first start has been made in the agency's commitment to reviewing the problem. Perhaps an even more important part of this crusade to "do no harm" is one that all pediatricians and children's health professionals need to embark upon immediately: teaching our patients and their parents about the risks and benefits of these so-called soothing nostrums and the importance of substituting them for the best cure for colds (albeit one that few of us really likes to accept) -- a tincture of time.

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