(Adds FDA, Sen. Dodd comments, paragraphs 11, 18-19)
WASHINGTON, Oct 7 (Reuters) - Oral cough and cold medicines sold over the counter should not be used in children younger than 4 years old because of the risk of rare complications linked to inappropriate use, manufacturers said on Tuesday.
Most problems occurred in children who were given the wrong dose or who took the medicine accidentally, the Consumer Healthcare Products Association (CHPA), which represents Procter & Gamble Co PG.N, Novartis AG NOVN.VXNVS.N and other big drugmakers, said.
“We’re doing this out of an abundance of caution,” the group’s president, Linda Suydam, said.
“Research shows that dosing errors and accidental ingestions -- not the safety of the ingredients themselves when properly dosed -- are the leading causes of rare adverse events in young children,” the group said in a statement.
The association said it made the decision in consultation with the U.S. Food and Drug Administration, which last week held a public meeting to weigh the controversial use of such products in children.
Manufacturers have maintained that nonprescription cough and cold products are safe when used as directed.
But doctors and consumer advocates have called on the agency to reject use of the medicines in children as old as 12. They argued the products have never been proven safe and effective, making any risk too great to give them to children.
Reported complications have included seizures, stroke and other side effects.
FDA officials and the industry have already said the products should not be used in children younger than 2. The FDA was still weighing what action to take in older children but said it supported the industry’s new limits.
“We are continuing to assess the safety and efficacy of these products,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said.
Some doctors welcomed the move to expand the warning as a way to keep parents of toddlers from buying potentially dangerous products.
“That’s the age group where they grab the bottle and chug it down,” said Dr. Joshua Sharfstein, health commissioner for Baltimore, Maryland, who last week urged the FDA to reject the medicines for those younger than 6. “There’s a lot of concern about toddlers ... I think it’s a big step forward.”
Still, other advocates said the move did not go far enough and called on Congress to force the FDA to require all children’s nonprescription cold products to undergo an agency review to prove they work before allowing them on the market.
Currently, the medicines are available under decades-old FDA rules that allow over-the-counter products to be sold without clinical trials showing their risks and benefits.
“The bottom line remains the same: that these products have never been proven to work in children,” said Diana Zuckerman, president of the National Research Center for Women & Families.
FDA officials have said changing the rules could take years. But Peter Lurie, deputy director of Public Citizen’s Health Research Group, said the agency could act sooner if it wanted. “They’ve taken the slow track to getting these products off the market,” he said.
The agency has taken too long to act, Sen. Chris Dodd, a senior member of the Senate Health, Education, Labor, and Pensions Committee, wrote in a letter to the FDA.
“Studies to simply determine the proper dosing for these products alone are wholly inadequate,” the Connecticut Democrat said in a letter.
The industry group said it was conducting a variety of studies to look at proper doses as well as efficacy, something FDA’s Woodcock said could take years to complete.
It limited its advisory to those under 4 because data showed most problems occurred in 2-year-olds and 3-year-olds, CHPA’s Suydam said.
Companies were rolling out products this week with packaging that cautions parents not to use the medicines in such young children, she added.
Cough and cold medicines aim to treat cold symptoms such as runny noses and congestion. There is no cure for the common cold, which can be caused by various viruses.
The CHPA’s move only applies to syrups and pills and does not include products such as nasal sprays and rubs.
Products containing certain antihistamines will also warn parents against using them to help their child sleep, the association said.
Both the industry and the FDA have cautioned parents to carefully measure the amount of cough or cold medicine they give their child and to keep the products out of reach.
Parents may see items with the old advice warning against use in children under 2 until new ones are stocked in stores. (Editing by Dave Zimmerman, Gerald E. McCormick, Leslie Gevirtz)
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