Canada’s national health authority has announced cough-and-cold medicines will be relabeled to indicate they should not be used in children under 6.
It’s a move that could soon be repeated in the United States as the FDA considers requests ban the use of these drugs in children under 12. In October, the FDA announced over-the-counter cold medications should not be used in children under two.
“FDA strongly recommends that over-the-counter [OTC] cough and cold products should not be used for infants and children under 2 years of age because serious and potentially life-threatening side effects could occur.”
“There are a wide variety of serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness,” reads an FDA statement.
Canada’s relabeling move takes that age to 6 on the conclusion that the risk to children is serious while the medication has no proven effectiveness. The change will be made in fall 2009.
“Although cough and cold medicines have been used by children for many years, there is limited evidence supporting their effectiveness in [children under six],” reads the Health Canada announcement.
The agency has a list of active ingredients that should be avoided on its Web site as well as suggestions for how parents should treat children with colds. Suggestions include the usual advice: plenty of rest, clear fluids, and adequate humidity.
Recent research in the U.S. has found that many parents are giving their children an overdose of these medicines, heightening the risk.
The report, published in the Annals of Emergency Medicine, looked at 189 medication overdoses. It found that some overdoses were a form of child abuse, while others were the result of parents trying to treat their children, or overwhelmed care-givers looking to quiet the children down.