Banning over-the-counter cough and cold medicines for children under six might drive parents to resort to adult medicines, a U.S. health official said in weighing a recall of products to fight runny noses, hacking and congestion.
Some pediatricians and consumer groups are seeking a ban on the sale of the cough and cold medicines for children, saying the value of the products remains unproven and they are potentially risky.
At a public hearing Thursday, officials with the U.S. Food and Drug Administration agreed there is a lack of solid evidence to support the use of the pediatric cough and cold medicines, especially in those aged two to six.
But if parents turn to adult medicines, the results could be worse, said Dr. John Jenkins, head of the U.S. Food and Drug Administration's Office of New Drugs.
"That is a concern for us," said Jenkins. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."
The FDA could ban companies from marketing products targeted to young children, require stricter labels, or require prescriptions for the products instead of allowing them to be sold over the counter. It could be months before a decision is reached, Jenkins said.
Several pediatricians told the hearing that the medicines have few benefits for cold symptoms in children, which usually clear up on their own. The medicine comes in the form of pills, syrups, nasal sprays and rubs.
"When a treatment is ineffective, its risks — unless zero — always exceed its benefits," said Dr. Michael Shannon of Children's Hospital in Boston.
Likewise, the American Academy of Pediatrics said over-the-counter products don't help treat coughs and colds in children under six, and should not be given because of the risk of side-effects.
Currently, Health Canada and the FDA advise parents not to give cough and cold medicines to children under two without first checking with a doctor.
When the medicines were allowed on the market, drug companies did not have to provide data on how safe and effective the products are in children, but extrapolated from data on adults.
The Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers in the U.S., said unintentional overdoses are preventable.
"The data clearly show a majority of adverse events are direct result of misuse of our products," said Linda Suydam, who heads the industry group.
Companies are launching studies to evaluate individual ingredients in the medications and changing packaging to improve dosing, she added.