Skip to main content

Update: FDA issues warning on OTC cough-cold for children under two


ROCKVILLE, Md. The Food and Drug Administration on Thursday issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter cough- cold products should not be used to treat infants and children less than 2 years of age on account of serious and potentially life-threatening side effects.

The announcement does not include the FDA’s final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. “Many of these drugs were monographed, as mentioned in the advisory committees, we’ll have to go through a working group process,” Charles Ganley, director of FDA’s Office of Nonprescription Products, told reporters during a conference call Thursday morning.

“This announcement will bring this issue back into the public consciousness,” Granley acknowledged, especially as the announcement comes as illness rates in upper respiratory illnesses starts to ramp up this season. And while CHPA and its vendor members recalled products marketed to children under two last fall, this could have an adverse impact on the sales of kids cough and cold medicines.

 “The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2,” Ganley stated. “These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2.”

Medicines marketed to this age group carried the warning “consult your physician” for children under age two up until the fall of last year, when industry voluntarily pulled all product marketed for use in toddlers off the market. Though the “FDA has never endorsed use of these products” in children under two, Ganley noted, rather leaving that discretion on whether or not to use those medicines in infants to pediatricians and family practitioners. 

The move was heralded by the Consumer Healthcare Products Association. “Safety has always been and continues to be our top priority,” stated Linda Suydam, CHPA president. “Last fall, the leading makers of OTC, oral cough and cold medicines for infants voluntarily withdrew these medicines out of concern that their potential misuse could lead to possible overdose among very young children. While CHPA and its member companies believe that the large majority of parents and caregivers know how to safely and appropriately administer these medicines, and that they are safe when taken as directed, we took this voluntary action recognizing that infants are especially vulnerable to accidental misuse.”

Today’s statement is based on the FDA’s review of data and discussion at a joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees on Oct. 18 and 19, 2007, the FDA stated.

Pending completion of the FDA’s ongoing review, FDA recommended that parents and caregivers who choose to use OTC cough and cold medicines for children ages 2 to 11 years should: 

  • Follow the dosing directions on the label of any OTC medication;
  • Understand that these drugs will NOT cure or shorten the duration of the common cold; 
  • Check the “Drug Facts” label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients; 
  • Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs. 

A decision on whether or not cough-cold medicines are appropriate for children older than two is expected in the spring.

This ad will auto-close in 10 seconds