A few years ago, manufacturers of children’s cough and cold medicines revised their labels because the dosages were confusing and unsafe. (See our blog “Cold Medicines Are Dangerous for Very Young Children.”) The labels were changed to direct parents not to give these meds to kids younger than 4.
Last month, the New York Times reported, the effort to revise label information has resulted in a significant decrease in emergency hospital visits by toddlers and infants with problems suspected to be the result of taking these meds.
A study published in the journal Pediatrics 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 younger than 2 accounted for 4 in 100 emergency visits for suspected drug-related effects before the measures were taken in 2007, but accounted for slightly more than 2 in 100 afterward. Among 2- to 3-year-olds, ER visits associated with cough and cold medicines dropped from 9 ½ in 100 to 6 ½ in 100.
But there was no significant reduction in emergency visits among children 4 to 11 — their numbers dropped from 6 ½ in 100 to about 5 ½ in 100.
The report could fuel debate about when it is safe for children to be given cough and cold medicines. Dr. Matthew M. Davis, professor of pediatrics and public policy at the University of Michigan told The Times, “I would call this Chapter 1 in the story. 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. Daniel Frattarelli, a former chairman of the committee on drugs at the American Academy of Pediatrics, wants “do not use” labeling for children 6 and younger. “The label doesn’t reflect the current evidence that these medications are ineffective for treating cough and cold symptoms in kids under 6,” he told The Times.
The FDA has been reviewing the safety and efficacy of over-the-counter cough and cold medicines in children for several years. No one was able to tell The Times when the work would be complete.
The new study found that most babies and toddlers in the ER survey with problems thought to be related to these medicines consumed them when parents didn’t see them. To a 2-year-old, a cold pill can look like candy.
One pediatrician told The Times of a 3-year-old patient who drank cough medicine that her 10-year-old sister had left on a bathroom shelf with the cap secure. The toddler experienced an elevated heart rate, agitation, then became drowsy. Showing signs of an overdose, the kid ended up in an emergency department.
The pediatrician said that although she understands why parents use cough and cold drugs, she found it “astonishing” that emergency room resources were still squandered on “products that are not proven to work and have been repeatedly implicated in adverse events.”
This year, according to the poll referenced in our blog above, 4 in 10 parents reported giving cough medicine or multi-symptom cough and cold medicine to children under 4. That’s just not a good idea.