Government researchers said on Monday that those moves have had a remarkable effect: a significant decrease in emergency hospital visits by toddlers and infants with suspected medical problems after using these medicines.
Dr. Daniel Frattarelli, a former chairman of the committee on drugs at the American Academy of Pediatrics, praised the study, saying it showed that "the label is a very powerful tool for changing parent behavior."
In the new study, published in the journal Pediatrics, researchers at the Centers for Disease Control and Prevention reviewed data from 63 hospitals to estimate the number of emergency visits from 2004 to 2011 by young children who had taken cough and cold medicines.
Children under 2 accounted for 4.1 percent of all emergency visits for suspected drug-related effects before the 2007 withdrawal, the researchers found, and accounted for 2.4 percent afterward. Among 2- to 3-year-olds, emergency room visits linked to cough and cold medicines decreased to 6.5 percent from 9.5 percent after the label change.
Yet there was no significant reduction in emergency visits among children ages 4 to 11. Among 4- and 5-year-olds specifically, visits attributed to cough and cold drugs increased to 6.5 percent from 5.6 percent.
"We're making great progress in under-2s, and we're making relatively good progress in 2 to 3s," said Dr. Don Shifrin, a pediatrician in Seattle and a spokesman for the American Academy of Pediatrics. "But we'd like better news for kids over 4."
The new report may reignite the debate over when it is safe for parents to give cough and cold medicines to their children, some experts said.
"I would call this Chapter 1 in the story," said Dr. Matthew M. Davis, a professor of pediatrics and public policy at the University of Michigan in Ann Arbor. "Chapter 2 is going to require additional changes in policy to reduce adverse drug events for older children, 4 and older, and to ensure safer medications in the home medicine cabinet for all ages."
Dr. Frattarelli said he would like to see "do not use" labeling for children ages 6 and younger, since the drugs continue to be misused for 4- and 5-year-olds.
Image: Cough medicine, via Shutterstock