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FDA: Are Cold Drugs Harmful for Children?

Posted on: Friday, 2 March 2007, 12:00 CST

By Gardiner Harris

WASHINGTON -- Federal drug regulators have started a broad review of the safety of popular cough and cold remedies meant for children, a top official said Thursday.

The official, Dr. Charles J. Ganley, director of the office of nonprescription drug products at the Food and Drug Administration, said in an interview that the agency was "revisiting the risks and benefits of the use of these drugs in children" and that "we're particularly concerned about the use of these drugs in children less than 2 years of age."

In high doses, cold medicines can affect the heart's electrical system, leading to arrhythmias. Some medicines affect the blood vessels and in high doses have been associated with hypertension and stroke. In rare cases, children have been injured even when given recommended doses.

In a recent study of hospital emergency room records from 2004 and 2005, the Centers for Disease Control and Prevention found that at least 1,519 children who were 2 years old had suffered serious health problems after being treated with common cough and cold medicines. Three of the children died, the disease control agency found.

The FDA said it was too early to predict whether the review would lead to new regulations. Its comments came in response to a petition filed Thursday by a group of prominent pediatricians and public health officials demanding that the agency stop drug makers from marketing cold and cough medicines for children younger than 6. The petition says that the medicines do not work and that in rare cases they can cause serious injury.

Popular medicines like Toddler's Dimetapp, Infant Triaminic and Little Colds, which are marketed for use in children as young as 2, should not be given to young children under any circumstances, the petition says.

Like hundreds of older drugs, many of the medicines in these products do not get a thorough safety review by the FDA.

"So many people use these products even though they have no effect on colds and there's a real risk of a problem," said an author of the petition, Dr. Joshua Sharfstein, a pediatrician and the health commissioner of Baltimore.

Ganley, of the FDA, said most over-the-counter cold and cough medicines had not been tested adequately in children. The doses recommended on many of the products' labels were no better than educated guesses, he said.

"We have no data on these agents of what's a safe and effective dose in children," Ganley said.

Linda A. Suydam, president of the Consumer Healthcare Products Association, a trade group of companies that market over-the- counter cold remedies, said the remedies had been approved by the FDA and had been used for decades by millions of Americans. Consumers should take only the recommended doses, Suydam said.

Doug Petkus, a spokesman for Wyeth, which makes Toddler's Dimetapp, agreed, adding that "parents of children under the age of 2 are encouraged to seek the advice of a physician before administering any over-the-counter medicine."

Such cautions "are clearly stated in product labeling," Petkus said. The pediatricians who petitioned the drug agency acknowledged that children's cough and cold medicines were generally safe when given in recommended doses. But they added that overdoses were common, for a variety of reasons. Parents sometimes give their children two different brands, unaware that they contain the same active ingredients. Overdoses can also result when frantic parents try to shove eyedroppers or cups of medicine into the mouths of crying, spitting babies.

The safety problems might be worth risking, the petitioners said, if the medicines worked to suppress coughs or clear stuffy noses. But according to a growing number of studies in children, the drugs are no better than placebos.

"There is widespread consensus that there is no good evidence for the effectiveness of several of the compounds used in cold medicines," said Dr. Ian M. Paul, an assistant professor of pediatrics at Penn State College of Medicine who has studied the medicines. Last year, the American College of Chest Physicians recommended that parents avoid using cough and cold medicines in children, especially young ones, because the medicines can cause serious problems.

Despite these growing worries, sales of the drugs are booming. Most major pharmacies carry a dozen or more brands.

The market for these medicines is fed by parents looking for anything to get their children to sleep peacefully. Children suffer an average of six to 10 colds each year, far more than adults. A 1994 study found that during one 30-day span, more than a third of the nation's 3-year-olds were estimated to have been given over- the-counter cough and cold remedies.

The products' labels and advertising strongly suggest that they work, many with flavors like grape and cherry.

Little Colds has a cartoon of a cheerful, crawling infant wearing only a diaper. It promises that it "safely and gently relieves."

"Parents will do anything for their kids," said Sharfstein. "They will buy expensive syrups if they think their kid will do better."

Source: THE NEW YORK TIMES

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