FDA addresses OTC cough and cold medications for kids

November 1, 2008

FDA officials consider whether OTC cough and cold medications are appropriate for young children.

It was clear at an October 2 hearing that the Food and Drug Administration (FDA) is on the horns of a dilemma. There is little evidence that the over-the-counter (OTC) cough and cold formulations work. But they are so deeply engrained in the culture-for powerful if not good reasons-that removing them might cause big problems.

Last year, two committees that advise FDA voted jointly to say that the medications should not be used in children under age 6 while new rules about needed research were being considered. In January 2008, FDA itself advised parents and others not to use the medications for children under age 2, and to take precautions in using them in children older than 2.

Now the agency is gathering information for a proposal to change the actual legal rules, called the monograph, under which these medications are marketed. The monograph, written in the 1970s, describes the conditions under which the medications are "generally recognized as safe and effective."

A study in Pediatrics this year estimated that 7,091 children under age 12 are treated in emergency rooms for adverse events related to these medications. Unsupervised ingestions accounted for two thirds of the problems. However, 93% of the children did not need admission or extended observation.

David Bromberg, MD, a Frederick, Md. pediatrician, spoke for the American Academy of Pediatrics. He noted that at the time these drugs were approved, "efficacy data in adults were extrapolated to children, and a safe therapeutic window for dosing children was never clearly established. Further, published trials over the past two decades have found these products to not be more effective than a placebo, while numerous safety concerns have surfaced."

But given the products' pervasiveness, a key issue for FDA is whether taking them off the market could create greater problems. For example, asks FDA, will parents use the adult formulations for their children instead? Will they turn to "natural" products, for which FDA can exert less control over manufacturers' claims?

Bromberg told FDA it's unclear whether the risk of children being given adult formulations would be greater than the current situation. Phillip Walson, MD, a former pediatrics and pharmacology professor at the University of Cincinnati who consults with the medication makers' trade association, asserted a change in availability would definitely increase the use of adult versions, along with other hazards.

"It's extremely difficult for parents to watch their child suffer from symptoms that they as parents have personally used these products to treat," he told the panel.

Walson pointed to a Gallup survey done this year that found that 24% of caregivers of children ages 6 months to 11 years said they would give children OTC products for older children and adults if the medications for younger children were not available. Another 40% said they would use natural nonmedication remedies.

Walson said he has seen a two-year-old who died of liver failure after being given a natural "herbal" product. Indeed, he said an education campaign is necessary because "there is a huge marketing group promoting these natural, unproven, less regulated alternatives."

There is also the potential for an increase in antibiotic use, he said, and the possibility parents will turn to inappropriate use of inhaled corticosteroids or other inappropriate products.

Watson has also seen children burned by steam in attempts to treat colds. He added that humidifiers can be contaminated with bacteria and cause electrical hazards. Even honey poses a botulism risk.

In other parts of his testimony, AAP's Bromberg spoke about whether efficacy data should be extrapolated from adults to children over 12.

"The fundamental problem is that the evidence from the published adult literature does not show conclusive benefits from most of these products," he said.

Yet it may not be feasible to do the many studies needed to show safety in these products, much less efficacy. Bromberg said that because current data do not show safety and efficacy, that kind of research is essential if the medications' use is to continue.