Health Canada's Decision on Cough and Cold Medicines

Information
December 2008

Cough and cold medicines have a long history of use in children; however, there is limited evidence supporting the effectiveness of over-the-counter cough and cold medicines in children. This is partly due to the fact that for many years it was assumed that cough and cold medicines worked the same way in children and adults.  Therefore, the products for children were approved based on estimations from studies on adults.  However, there is a better understanding now of how the ingredients found in cough and cold medicines can behave differently in children than adults. 

Reports of misuse, overdose and rare but serious side-effects have also raised concerns about the safety of these products in children. While the link between the adverse events and the products cannot be definitively proven by these reports, they are signs that Health Canada cannot ignore.

Based on a preliminary analysis of available information, Health Canada recommended in October 2007 that over-the-counter cough and cold medicines not be used in children under the age of 2, unless directed to do so by a health care practitioner. Since that time, Health Canada has completed its analysis, received input from a Scientific Advisory Panel convened in March 2008, and decided that certain non-prescription cough and cold medicines should not be labelled for use in children under 6.
 
There were several other factors that Health Canada took into consideration in determining age 6 to be the cut-off for use of these medicines, such as:

• Recommendations from Canadian and international health professionals and experts that these medicines should not be used in children under 6;
  
• Body weight and its effect on how medicines work. Some children between the ages of 2 and 6 years may weigh the same as other children who are less than two years old, the most vulnerable group;
• Children under the age of 6 years generally have more colds compared to older children and therefore, are likely to be exposed more frequently to these medications; and
• Younger children are less likely to be able to communicate a potential side-effect from a cough and cold medicine and to ask their parents/caregivers for help in the same way a child over the age of 6 can.

As a result of Health Canada's decision, the labelling of cough and cold medicines for use in children must be changed by fall 2009 to say they should not be used in children less than 6 years of age. These products will also require enhanced labelling for children aged 6 to under 12, child resistant packaging, and the inclusion of dosing devices for all liquid formulations. Since many of the cough and cold medicines currently on the market for use in children under 6 also have instructions for older children and adults, products will still be available to these groups while the new labelling standard is being put in place. As a result, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products during this cough and cold season.  These medicines can still be used in children 6 and older, and adults. Medicines with dosing information only for children under 6 years of age are to be removed from the Canadian market by fall 2009 as well.

Health Canada also recognizes that children's doses should consider body weight, as was concluded by the Science Advisory Panel. Therefore, Health Canada is seeking additional scientific information to help determine the most appropriate dosing for children, and will require children-specific efficacy data with future submissions for children's cough and cold medicines. Health Canada intends to use the information from these studies to further revise the labelling standard.

Advisory: Health Canada Releases Decision on the Labelling of Cough and Cold Products for Children