FDA Ban Leaves Children Out in the Cold

An advisory committee of the Food and Drug Administration recently recommended banning the sale of all over-the-counter cold medications for children under 6, concluding that pharmacies should not sell drugs with serious risk and no benefit to kids.

There’s no question there are overdoses of cold medicines, often due to confusing labeling and dosing. They’re particularly dangerous since the elixirs can contain up to five different kinds of drugs: anti-inflammatory, decongestants, anticough, antihistamines, and expectorants.

Dr. Michael Shannon, a toxicologist at Children’s Hospital, testified to the FDA that more than 300,000 calls about the drugs were made to poison-control centers nationwide from 2001 to 2005, more than 1,500 children were treated in emergency room for overdoses in two years, and several died, usually from the decongestant component. These kinds of numbers prompted Dr. Joshua Sharfstein, the Baltimore health commissioner and my former colleague from residency, to file a citizen’s petition that resulted in the advisory committee’s action.

But the recommendation dramatizes the tension between policy makers and academics who advocated for the ban and rank-and-file pediatricians and parents on who have to deal with ill children. An outright ban is ill-advised for three key reasons.

First, when used properly, the drugs are almost certainly safe. In the medical literature to date, there is no report of a healthy child who had serious injury or death clearly caused by cold medicine used at the proper doses. Children get hurt by dosing foul-ups, not normal use. Rather than selectively banning certain over-the-counter drugs, we should find ways to make them safer. Across-the-board standardized concentrations for kids’ drugs might avoid more harm than an outright ban on specific cold medicines. Infant Tylenol, for example, is more than four times more concentrated than Children’s Tylenol. Also, pediatric dosing must be overhauled, and dosing cups need to be replaced with oral syringes that are calibrated by a child’s age.

With combination cold medications, drugmakers should list active ingredients in large letters (perhaps with a standardized, color-coded package) in an obvious manner, and flag each of the three ingredients that are dangerous when overdosed: decongestants, antihistamines, and acetaminophen (Tylenol). More conservatively, the FDA also could require each component to be sold separately.

Second, the notion that cold medicines are useless in children may be wrong. Data from evidence-based collectives such as the Cochrane Collaboration suggest that anticough and expectorant drugs don’t help people. (While that’s probably true, it’s important to note the studies are biased toward showing no effect, since none actually counted how much the kids coughed. They only recorded parents’ subjective impressions.)

However, in reviewing the medical literature, there is only one randomized trial of a decongestant-antihistamine combination looking at short-term sleep and runny-nose relief in a high-quality pediatrics journal since 1990 in the U.S., and it involved only about 30 kids in Seattle getting the active drug. In that study, kids under 6 treated with the drug tended to have less runny noses, and were significantly more likely to fall asleep after two hours. Thus, dismissing decongestants and antihistamines along with anticough drugs is premature, especially since they likely help older children and adults.

Third, banning all cold medications outright may cause unintended harm, especially if they become available only by prescription. Desperate parents may overwhelm pediatric primary care offices during cold seasons. It’s best to keep most colds away from doctors, since in a 1998 Kentucky study, almost two-thirds of visits for colds resulted in inappropriate antibiotic prescriptions, which don’t help symptoms and also may contribute to outbreaks of resistant organisms.

In publicizing the rampant unethical marketing and frequent erroneous use of cold medicines, the FDA advisory committee has performed an important function. But leaving parents without any access to cold medicines is overkill, especially when little else works. Though colds in children may appear harmless, they’re the source of tremendous parental anxiety, loss of sleep routines, and lost time at work. Parents deserve the option of giving medicines that might help, even if it’s only for a few hours. Hopefully, the FDA’s final action will be nuanced, and will still permit sales of certain cold medications.

Ask your own pediatrician: if your previously healthy toddler was awake all night with a cold, would you recommend a carefully measured dose of a decongestant and pain reliever? Odds are that he or she will probably disagree with the FDA panel’s belief that the answer should almost always be no.-

Darshak Sanghavi is a pediatric cardiologist at UMass Medical School and author of “A Map of the Child: A Pediatrician’s Tour of the Body.” This article first appeared in the Boston Globe.