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Archived – Health Canada Releases Decision on the Labelling of Cough and Cold Products for Children

Starting date:
December 18, 2008
Posting date:
December 18, 2008
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Product Safety, Product label update, New safety information
Audience:
General Public
Identification number:
RA-110002511

Backgrounder: Health Canada's Decision on Cough and Cold Medicines
Video: One-minute video clip with Health Canada spokesperson

Health Canada is advising consumers of the outcome of its review of cough and cold medicines for children under the age of 12.

Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines that have dosing information for children to indicate that these medicines should not be used in children under 6. The products affected are those containing any of the active ingredients listed below that are given orally:

Table 1: Active Ingredients Affected by Health Canada's Decision on Cough and Cold Products for Children
Therapeutic Category (Purpose) Active Ingredients
Antihistamines in cough and cold medicines
(used to treat sneezing, runny nose)
brompheniramine maleate
chlorpheniramine maleate
clemastine hydrogen fumerate
dexbrompheniramine maleate
diphenhydramine hydrochloride
diphenylpyraline hydrochloride
doxylamine succinate
pheniramine maleate
phenyltoloxamine citrate
promethazine hydrochloride
pyrilamine maleate
triprolidine hydrochloride
Antitussives
(used to treat cough)
dextromethorphan
dextromethorphan hydrobromide
diphenhydramine hydrochloride
Expectorants (used to loosen mucus) guaifenesin (glyceryl guaiacolate)
Decongestants (used to treat congestion) ephedrine hydrochloride/sulphate
phenylephrine hydrochloride/sulphate
pseudoephedrine hydrochloride/sulphate

The relabelling of these medicines will be completed by fall 2009, in time for the next cough and cold season. During the current cough and cold season, medicines will remain on store shelves and in homes with the current labelling, which could include dosing information for children under 6, because many of these products also have dosing information for adults and older children on the same label. As a result, for this cough and cold season, parents or caregivers should consult a pharmacist or a health care practitioner when buying or using these products. These medicines can still be used in children 6 and older, and adults.

This decision is the result of a Health Canada review of these medicines, including the input of a Scientific Advisory Panel convened in March 2008. Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children. In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel's conclusions and details of the new Health Canada recommendations are posted on the Health Canada Web site.

Health Canada previously issued advice on the use of these medicines in an October 2007 Public Advisory. Based on a preliminary review, Health Canada at that time recommended not using over-the-counter cough and cold medicines in children under 2 years of age, unless instructed to do so by a health care practitioner. The current decision expands on those preliminary recommendations.

Until the relabelling of these products is completed, Health Canada advises parents and caregivers to follow these important guidelines:

  • Do not use these over-the-counter cough and cold medicines in children under 6 years of age.
  • With children older than 6, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included.
  • Do not give children medications labelled only for adults.
  • Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child.
  • Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines.
  • The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion. Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity.
  • For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.
  • If you are concerned about the child's health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation.

For more information about Health Canada's decision and the use of cough and cold products in children, consult the Health Canada Web site or call toll free at 1-866-558-2946.

For advice on how to properly dispose of medications, see the article entitled The Proper Use and Disposal of Medication.

For more information on the safe use of medicines, see the article entitled Safe Use of Medicines.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this Web site.

Health Canada's Decision on Cough and Cold Medicines

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.

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