Advisory
2007-147
October 11, 2007
For immediate release
OTTAWA - Concerns have been raised regarding the safety of "over-the-counter" (non-prescription) cough and cold products in children. Health Canada is advising consumers on the appropriate use of these products, including drugs and natural health products, particularly in children under 2 years of age. Life-threatening adverse events, including unintentional overdose, have been reported to Health Canada in association with the use of these products in children under 2 years of age.
There are more than 700 authorized non-prescription cough and cold products marketed in Canada. The Department is in the process of determining if the labelling of these products is sufficient to ensure that parents, caregivers and prescribers have all the information needed to make an informed decision concerning the safe use of these products.
Before using over-the-counter cough and cold remedies in children under 2 years of age, Health Canada urges caregivers to consult a healthcare practitioner to assure that their use is safe and appropriate. In addition, Health Canada strongly advises parents and caregivers to carefully read the labels and instructions for these products and to check the medicinal ingredients before giving them to any child, especially under the age of 2. Many of these products contain the same medicinal ingredient(s), and giving more than one product with the same ingredient or multiple doses of the same product could lead to an overdose.
Special attention should also be given when using cough and cold products at the same time as medications sold over the counter to control fever (for example, acetaminophen or ibuprofen), in order to avoid exposing children to excessive doses of these medications, since some cough and cold products also contain these medicinal ingredients.
Important Recommendations
Children under 2 years of age
Do not use cough and cold products, including drugs and natural health products, in children under 2 years of age unless instructed to do so by a healthcare practitioner.
Even if the cough and cold products are labelled for use in children under 2 years of age (for example, they use the word "infant" in their name or have dosing instructions for infants) it is still preferable to discuss the use of these products with your healthcare practitioner before giving them to any young child.
Children of all ages
If it is necessary to give a cough and cold product to a child, make sure that you read all labels and instructions before doing so. If the product does not contain dose information for children, then it should not be used in children.
Do not give a child a larger dose than is recommended or use the product more frequently than is recommended in the labelling and instructions.
Take note of the medicinal ingredients in the product, particularly if you may be giving more than one product to a child. Be aware that many products contain the same medicinal ingredient(s) and combined use could lead to overdose. Some herbs used in cough and cold medications and some over-the-counter medications used to control fever may also have medicinal ingredients similar to those in other cough and cold products.
Because cough and cold medications often contain multiple ingredients, it is advised not to give more than one cough and cold product to a child.
Talk to your healthcare practitioner if you have questions about the proper use of these products, dosing and administration information, or the medicinal ingredients in the products you are using.
There is no cure for the common cold. Children will usually recover from coughs and colds in time on their own. The common cold is a mild, viral infection that can be managed by rest, sufficient fluid intake and comfort measures.
In young children and babies, it is sometimes important to rule out serious illnesses (for example, pneumonia or other infections) which may present with cold-like signs and symptoms; this is especially important if symptoms persist or if the child's condition deteriorates.
If you are concerned about the child's health, the child should be brought to a healthcare practitioner for medical evaluation.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to these health products, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the Health Canada Web site.
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Media Enquiries:
Paul Duchesne
Health Canada
(613) 954-4807
Public Enquiries:
(613) 957-2991
1-866 225-0709
