Kids' cold medicines face FDA scrutiny

Federal agency to look at effectiveness, safety of OTC products

August 23, 2008|By Kelly Brewington | Kelly Brewington,Sun reporter

Federal regulators are planning to launch a broad new review of whether over-the-counter cold medicines are safe and effective for children under 12.

The Food and Drug Administration said yesterday that it will hold public hearings on the medications in October, the first step in what will likely be a long study that could lead to stricter age guidelines, changes in formulas and recommended dosages, and the removal of some products from the market, said Dr. Janet Woodcock, director of the FDA's center for drug evaluation and research.

"We know that one in 10 children in any day of the week is on these medicines. They are very widely used, and they deserve to have modern evidence," she said.

"If the evidence is negative, then they shouldn't be available."

In January, the federal agency urged parents to stop giving such medicines to children under 2, after warnings by medical experts that they could do infants more harm than good.

That decision came on the heels of an aggressive effort by Baltimore Health Commissioner Joshua M. Sharfstein and a group of leading pediatricians to push the FDA to look closely at child cough and cold medications.

Last fall, a federal advisory committee recommended that the remedies should not be given to children under 6 and found no evidence that they are effective in children under 12.

The panel suggested companies change the wording on labels of the syrups and drops from "Consult a Physician" to "Do Not Use," and objected to the phrase "Pediatrician Recommended" that appears on packaging.

The panel also recommended the industry conduct trials to determine the safety and effectiveness of the medicines in children.

Woodcock said that when the syrups and drops came on the market in the 1970s, the FDA did not require them to be tested on children. Given mounting concerns, FDA officials now think that the medicines should be subject to more rigorous standards.

"For children under 12, these medicines were not studied by modern standards," Woodcock said. "Back in that time, there weren't special clinical trials in children.

"But the new science in children tells us it is actually necessary to study children to be certain we are giving the right dose, to measure the side effects and the effectiveness.

"We believe these drugs need to be conformed to modern standards."

Industry reassures

The industry maintains that its products are safe. Adverse reactions are largely a result of children accidentally ingesting the medicines or misusing them, said Elizabeth Funderburk, a spokeswoman for the Consumer Healthcare Products Association.

Nevertheless, she said, companies have begun studies on proper dosages, part of a larger effort to test the medicines' efficacy.

The companies look forward to working with the FDA in its review, she said: "This is more a continuation of how best to ensure that parents and caregivers are safely and appropriately administering these medicines to children."

Lengthy process

Woodcock said the FDA review could take several years.

The first step is a public hearing Oct. 2 at the Sheraton Washington North in Beltsville. Medical experts, pharmacy organizations and drugmakers are expected to present data on the products.

Then, based on findings from the hearings, the FDA will publish proposed changes in the requirements for the medicines.

The public will be able to comment on the proposals and the FDA will call for more studies before writing final changes to regulations that dictate how the drugs may be marketed.

Until then, parents should follow appropriate dosages and be careful where they store the medicines so that children can't reach them, Woodcock said.

She said that while FDA officials are still investigating the safety concerns for children 2 through 6, they agree with the findings of the advisory panel that more research must be done on how the products affect young children.

"Right now we are saying they should not be used in children under 2, to follow very carefully the label direction for children 2 to 6 and keep them out of the children's reach," she said.

"The vast majority of the problems are children are getting into these medicines and drinking them."

When in doubt, parents should consult the child's doctor, she said.

But Sharfstein and other local physicians said they advise parents of children under 6 to avoid the medicines entirely.

"They should be saving their money," Sharfstein said. "There is more reason than ever for parents not to use cough and cold medicine for their children. You have FDA reopening the rules and major associations, doctors, nurses and the FDA advisory committee saying not to use them."

Sharfstein began pushing the FDA to adopt new policies two years ago, after the deaths of four Baltimore children in six years were tied to the medications.

On the right road

Yesterday, Sharfstein called the FDA's decision to examine the drugs a "step on the road toward getting those unproven and unsafe medications off the shelves."

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