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.
“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.