CHICAGO – In what could lead to significant changes in how parents care for their sick children, a panel of advisers to the Food and Drug Administration said Friday that children under 6 should not take over-the-counter cough and cold medicines.

By a 13-9 vote, the FDA advisory panel said children ages 2 to 6 should not use cough and cold medicines such as antitussives, decongestants and antihistamines because their effectiveness has not been studied in kids, and the risks outweigh their benefits.

The vote comes a week after major manufacturers of over-the-counter drugs agreed to pull from pharmacy shelves cough and cold medicines for children under 2, citing the potential for misuse. The panel also said in a more definitive, 21-1 vote that such products should not be taken by children under the age of 2.

The danger comes from a high dosage or combination of medicines given in a short period of time. Doctors say problems tend to occur when parents give a child one brand that ends up not working and then try something else.

Echoing past complaints by doctors and previous studies, the panel cited the risks associated with the medicines, including heartbeat irregularities and death.

“The (panel) expressed concerns about the lack of studies that showed positive benefits these products have in children,” said Dr. John Jenkins, director in the FDA’s Office of New Drugs.

Although the FDA still has to weigh the panel’s recommendations, news of the advisers’ decision surprised some parents who thought the drugs might be OK for their older children.

“It grabbed my attention because I thought they were fine (for children older than 2),” said Chicago resident Susan Boin, who has four children under 10, including 5-year-old twins. “I thought, “OK, my kids are 5. This is serious.”‘


Kim Rode of Chicago also has been following the news about children’s cough and cold medications.

“We have used over-the-counter products for allergies, and they seemed to work with some success,” said Rode, who has a 4-year-old daughter. “But based on the report that came out, the next time I go to the doctor I’ll ask her what her thoughts are.”

The panel’s recommendations could roil a U.S. cold remedy industry that is valued at hundreds of millions of dollars.

Recommendations from advisory panels are usually followed by the FDA, but the agency does not have to do adhere to them. An FDA official told reporters on a conference call Friday afternoon that the panel’s recommendation would not likely lead to a ban on the products but to a labeling change to highlight risks and warn against use for children under 6.

Although the panel voted 15-7 that such products could be used for children between 6 and 12, studies have not been done on the products for safety and efficacy in that age group.

Some pediatricians say there is no evidence that they should even be used for older children up to 12 because of the lack of studies. Some studies that have looked at over-the-counter cold and cough medicines in adults questioned their effectiveness.

“I don’t think anybody has shown these medicines have been successful, so I was glad to see somebody come out with documentation,” said Dr. Joel Schwab, associate professor of pediatrics at the University of Chicago. “I have never been concerned about deaths, but they do make kids dopey and can make them hyper.”

Doctors advise parents to consult with their physicians and use acetaminophen, ibuprofen or saline nose drops for relief. For coughs in particular, elevate the child’s head with pillows at bedtime, run a humidifier and give her a lot of fluids.


Until the agency can make its final ruling, the FDA encouraged parents to pay close attention to labels on existing products because the same ingredients can be present in multiple products, raising the risk of an overdose.

The panel said over-the-counter drugs should face additional study that includes clinical trials, and it wants dosing devices to be required with liquid formulations. Dosing also should be standardized to improve safety and efficacy of the products.

But the over-the-counter drug industry, which includes Johnson & Johnson, Wyeth and Novartis AG, said the products are safe as long as parents closely follow the directions on the product labels and consult with their physicians before using.

“The data clearly show that these medicines are very safe when used as directed and that harm to (2- to 6-year-olds), while very rare, is attributable in most cases to accidental ingestion – an issue of safekeeping that is best addressed through education,” said Linda Suydam, president of the Consumer Healthcare Products Association, which represents over-the-counter drugmakers.

More than 800 over-the-counter cough and cold products are sold in the United States, the FDA said. Sales of cold and cough products are estimated at more than $3.7 billion annually, including more than $311 million in children’s cold remedies, according to Nielsen Co.

The FDA panel’s recommendations are the latest blow to over-the-counter remedies.

In January, the U.S. Centers for Disease Control and Prevention published a study of hospital emergency departments that found more than 1,500 children younger than 2 were treated for “adverse events, including overdoses, associated with cough and cold medications.” The report identified three deaths.

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(Chicago Tribune staff reporter Robert Manor contributed to this report.)

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(c) 2007, Chicago Tribune.

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AP-NY-10-19-07 2254EDT

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