Summary of Health Canada’s Decision Labelling of Certain Paediatric Non-Prescription Cough and Cold Products in Canada February 2006
BACKGROUND • Non-prescription paediatric cough and cold products for symptomatic relief have been widely marketed in Canada for decades. • Despite their long history of use, evidence clearly demonstrating therapeutic benefit for the use of these products in children under the age of 12 is lacking. • Reports of misuse, overdose and rare serious side-effects have raised concerns about the use of these medicines in children under 6.
HEALTH CANDA’S APPROACH • Reviewed scientific evidence and international approaches • Better understanding now of how children’s bodies react differently to certain medicines, and how cold viruses affect children differently. • Based on a preliminary review, Health Canada recommended in October 2007 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. • Convened Scientific Advisory Panel on Nonprescription Paediatric Cough and Cold Medications in March 2008. • The current decision expands on those preliminary recommendations.
HEALTH CANADA’S DECISION • Health Canada is requiring manufacturers to relabel orally administered cough and cold products with certain ingredients that have dosing information for children. The new labelling will say that these medicines should not be used in children under 6. • Products that remain on the market will need to be re-labelled accordingly, which includes the enhanced labelling requirements. • This decision carefully considers the available benefit and risk information, and the conclusions of a Scientific Advisory Panel of external experts convened by Health Canada to study the issue.
TYPES OF PRODUCTS AFFECTED • Antihistamines in cough and cold medicines (used to treat sneezing, runny nose) • Antitussives (used to treat cough) • Expectorants (used to loosen mucus) • Decongestants (used to treat congestion)
RELABELLING PERIOD • Health Canada is working with stakeholders in order to ensure that the relevant products are relabelled by the 2009 cough & cold season. • Health Canada recognizes that during this cough and cold season there will be products on the store shelves and in homes with current labelling that 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. • Health Canada will conduct an outreach campaign to inform parents and caregivers about the new labelling for over-the-counter cough and cold medicines.