Parents should not give cough and cold medication to children under 6, and should consult a health professional before giving it to those under 12, Health Canada warned yesterday.
There is insufficient information to prove children's cough and cold medicine is effective, the department said, announcing it will require all manufacturers to re-label their products to reflect the changes.
However, companies have until next fall to make the labelling changes, which means the medications will remain on store shelves this season.
The new warning extends restrictions made last year, when health officials in Canada and the United States said the products shouldn't be used in children under the age of 2.
The warnings were prompted by reports of dozens of serious side effects among children who took the medications in recent years, and a lack of data to show that they work.
Health Canada said five infants under 2 have died after being given the medication.
"The decision to recommend against the use under the age of 6 is based on a number of considerations, including among others the higher number of adverse events reported to Health Canada," said Marc Berthiaume, director of the marketed pharmaceuticals and medical devices bureau at Health Canada.
The move will help protect children and will send a new message that parents should be very careful when deciding to administer cough and cold medication to children over 6, said Michael Rieder, chair of the drug therapy committee at the Canadian Paediatric Society.
"I think that they actually made a responsible decision," he said.
However, drug manufacturers plan to fight the decision by submitting new information to Health Canada that shows children's cough and cold medication is effective among children under 6.
Until now, there have been no comprehensive studies looking at how well cough and cold medication works in children. Studies were traditionally conducted on adults and "the effectiveness data was assumed to apply to children," said Gerry Harrington, director of public affairs at the Nonprescription Drug Manufacturers Association of Canada.
Mr. Harrington said the industry will embark on new research to show the medication is effective in hopes that companies may once again be able to market the products for use in children under 6.
"The intent would be, once those studies are done, that these medicines would be looked at again," Mr. Harrington said.
The call for restrictions on the sale of cough and cold medications has been growing among pediatricians and advocacy groups who say there is little proof the products are safe or that they work. Earlier this fall, drug manufacturers in the United States said they would begin voluntarily labelling their products as not safe for use in children under 4.
Instead of giving medication, parents should make sure their children receive plenty of fluids, get lots of rest and remain in a comfortable environment when they come down with a cold, according to Health Canada.
