Pediatric Cold Medications Continue to Pose Dilemma

Cough and cold season has arrived, and many parents -- and some physicians -- are left wondering what their treatment options are for ailing infants and toddlers.

Their consternation stems, in large part, from two announcements made earlier this year -- one by the FDA and the other by the Consumer Healthcare Products Association, or CHPA, a not-for-profit association representing the manufacturers of OTC medications and nutritional supplements. Although both announcements agree that these products should not be used in young children, they differ on exactly how young.

FDA officials issued a public health advisory in January, recommending that oral OTC cough and cold medications no longer be used in children younger than age 2 years. More recently, CHPA took things a step further, saying its member companies would voluntarily change the labeling of such products to indicate the medications should not be used in children younger than 4.

Potentially adding to the confusion is CHPA's announcement that the manufacturers of these pediatric medications would be transitioning the newly relabeled and repackaged products onto store shelves throughout the 2008-09 cough and cold season, where they could be stocked alongside the same medications bearing the old labels.

Family physician Keith Stafford, M.D., of Greer, S.C., said many physicians will be reluctant to recommend OTC medications for any young children now because of potential liability issues. He said that despite the fact that the FDA recommendation likely arose from an extremely small number of cases -- most of which were probably due to improper dosing -- "no one will now recommend any parent give their young children these agents."

"This is a huge problem," Stafford said. "No parent wants to be told there is nothing to do for your sick child, but that is where we are at with the treatment of the extremely prevalent URI (upper respiratory infection)."

His fear, he said, is that the situation will prompt clinicians to prescribe antibiotics inappropriately.

The FDA's January action was spurred by a petition (11-page PDF; About PDFs) submitted by more than a dozen prominent pediatricians, public health officials and other health care professionals in March 2007. That group asked the agency to revise the products' labeling to state that OTC cough and cold medications should not be used in children younger than 6.

However, FDA spokeswoman Rita Chappelle said that changing an FDA monograph -- the rule that governs ingredients, permitted dosages, claims, warnings and labeling for OTC medications -- must be done through the federal rulemaking process.

"It's a time-consuming process that can take several years," Chappelle said.

The FDA began soliciting public comments on the issue this past August. Among the questions the agency asked at that time was whether cough and cold medications should continue to be available over the counter or should be restricted to prescription use. Interestingly, included in the background information provided in that request for comments was a description of recent CDC data indicating that children younger than 4 years were "more likely to experience nonallergic adverse events than older children."

The public comment period ended Dec. 2.

Chappelle said the comments received would be used to draft a proposed rule to revise the pediatric labeling section of the monograph for OTC cough and cold medications. That draft will be subject to another comment period before a final ruling is published.

Given the lengthy process involved in changing the monograph, the FDA approached CHPA about altering the products' labels. Elizabeth Funderburk, CHPA's director of communications, said the association agreed to make the product label changes out of an "overabundance of caution."

Eric Wall, M.D., M.P.H., of Shoreline, Wash., said the recommendations and other changes haven't altered his approach to treatment.

"I've been telling parents that cold medications under age 2 are unwarranted, even dangerous, and not recommended by me for at least the past 10 years or more," Wall said. "I have been recommending a cool mist humidifier, humidified air at night -- or simply steaming up a bathroom -- and oral fluids. I remind parents that these symptoms are self-limited and should resolve over a week or so, at most."

Wall served as chair of the (then) AAFP Commission on Science, which submitted comments to the FDA in response to the March 2007 petition.

In those comments, the AAFP commended the FDA on its "good, common-sense advice for parents" and for stressing the need for communication between parents and physicians. The Academy also pointed out that cold medications do not cure colds.

"They usually are not needed and only improve some of the symptoms," the AAFP said. "There is even some doubt that they do that. A review in JAMA (Journal of the American Medical Association) in 1993 found that no good evidence has demonstrated the effectiveness of over-the-counter cold medications in preschool children."

The Academy stated that further studies are required to clarify the role of cough and cold medications in children, noting that the products contain ingredients that are potentially dangerous and that could interact with other medications.

Chappelle said that the FDA is studying data on these products to determine if they are safe and effective. The agency also will examine the entire pediatric dosing range, which includes children as old as 17. She said the new monograph would determine a cutoff age for the use of these medications.