FDA Recommends Ban on Cough and Cold Medicines for Children

A US Food and Drug Administration (FDA) advisory panel recommends a ban on over-the-counter cough and cold medicines for children younger than six.

Citing a number of studies that showed the remedies were no better than a placebo (an inactive substance), the outside experts also recommend the medications be tested on children to see if they are effective.

The evidence that the medications work is "modest at best" even for adults, says Dr. Mary E. Tinetti, chairwoman of the FDA panel and a professor at Yale University School of Medicine.

In two separate votes at the end of two days of hearings on the safety of the medications for children, the advisers say the medicines should not be used in children younger than two or in those younger than six. A third vote, to recommend against use in children ages six to 11, was not approved.

The vote for additional testing of the medications in children preceded the votes to ban the products.

The recommendations apply to medicines containing at least one of the following ingredients: decongestants, expectorants, antihistamines, and antitussives.

The FDA does not have to follow its advisory panels' recommendations, but usually does.

Experts Note Various Problems with Use

Dr. John K. Jenkins, director of the FDA Office of New Drugs in the Center for Drug Evaluation and Research, says, "The recommendations may not lead to a ban of these products, but to a warning on the label.

"The message of the panel is that they haven't seen scientific evidence that these products work in children, and they were uneasy about extrapolating the adult doses for children," says Dr. Jenkins. "Parents should pay close attention to the directions on the label."

"We need to take back to the agency all the advice we heard and decide what we are going to do," says Dr. Jenkins. "This has to go through the rule-making process, which can take some time."

A ban already has the support of safety experts at the FDA, who published a 365-page review recently that showed decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts were also in favor of restricting children's access to cold remedies.

"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under six," says Dr. Michael Shannon, chief of the division of emergency medicine at Children's Hospital Boston.

"This recommendation is exactly what is needed to alert parents and policymakers about the erroneous labeling, marketing, and use of these products," he says.

Bruce Lesley, president of the children's advocacy group First Focus, says, "Moreover, these medicines are ineffective and dangerous to young children."

The products covered in the debate include approximately 800 popular medicines sold in the US under names such as Toddler's Dimetapp®, Triaminic® Infant, and Little Colds®. Experts estimate that Americans spend about $2 billion annually on these types of medications.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine, or ephedrine.

It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine, or chlorpheniramine.

Most of the deaths involved children younger than two.

Last fall, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.

That move affected only infant oral medicines, not those intended and labeled for use in children aged two and older, notes Dr. Shannon.

Dr. Shannon does not believe the recall by manufacturers goes far enough. It only affects children under two and not children between two and five, who make up two-thirds of those taking the drugs, he notes.

"They made an effort, but it was nowhere near far enough," says Dr. Shannon.

"These drugs interact with other drugs. These drugs have exaggerated effects on children who have other illnesses," he says.

Cold Products Cannot "Cure" a Cold

And nothing conquers the common cold, he adds.

"We have to accept the fact that there are no real treatments for the cold," says Dr. Shannon. "It's a mistake to think that there are medications that are really going to make a cold go away sooner or make the child feel much better.

"Medication for fever works, but these medications for cough suppression do not treat the common cold," he says.

In addition, these cold products simply do not work, according to Dr. Shannon.

"There is no reason to give something that costs money, is ineffective, and has potential risks," he concludes.

Another expert agrees with Dr. Shannon.

"Colds take a lot of time to nurture, and the medicines don't really speed up that process at all," says Catherine Tom-Revzon, Pharm.D., at Children's Hospital at Montefiore in New York City.

Tom-Revzon believes that rather than risking potential harm from these medications, it is better to remove them from the market.

Always consult your physician for more information.