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."
kelly.brewington@baltsun.com
