Members of the Nonprescription Drug Manufacturers Association of Canada announced the voluntary withdrawal of oral cough and cold medicines intended for use in children under the age of two years. The withdrawal is a highly cautionary response to rare patterns of misuse identified during the course of a review of safety data related to children’s cough and cold medicines.
When used as directed, these products are recognized as safe and effective; however this is a precautionary mesure to avoid potential misuse of these products, including unintentional overdoses, in children under the age of two.
The withdrawal does not affect cough and cold products intended for children two years of age or older nor does it affect pain relievers and fever reducers intended for use in children under the age of two years. These products remain available to parents and caregivers.
The medicines being withdrawn include:
Infant Tylenol(R) Cold dye free drops
Benylin (R) for Infants Cough and Cold Oral Drops
Benylin (R) for Infants Stuffy Nose Oral Drops
Dimetapp (R) Oral Infant Cold Drops
Dimetapp (R) Oral Infant Cold and Fever Drops
Dimetapp (R) Oral Infant Cold Drops Dye Free
Every year, millions of Canadians rely on cough and cold medicines to treat symptoms safely and effectively, both for themselves and for their families. The safety and effectiveness of the ingredients in these medicines, as well as their label directions and dosing instructions for children, are reviewed and approved by Health Canada before market authorization is granted.
As research methodologies and techniques have advanced, there has been recognition of the need to reassess the appropriate use of these medicines in children. For this reason, Industry, Health Canada and the United States Food and Drug Administration are currently reviewing the available evidence on cough and cold medicine use in children, with a view to ensuring that such use continues to be safe and effective. It was during the course of this review that the industry identified the misuse issue that has prompted the withdrawal of oral cough and cold medicines for use in children under the age of two years.