Health Canada is expected to issue an advisory warning people not to give over-the-counter cold and cough medications to children under two and adjust labels to reflect the concerns, CBC News has learned.

Canada's non-prescription drug industry has confirmed it will change its labelling to warn against use in children under the age of two.
(CBC)

The warning, which will come within days, follows an American study that says the medications have a questionable benefit and, in some cases, could be dangerous.

Earlier this year, the U.S. Food and Drug Administration completed an internal review of serious and life-threatening effects and deaths in young children dating back to 1969.

It found 54 deaths related to decongestants and another 69 related to the use of antihistamines. In many cases, the child was given the wrong amount of medication. Thousands more wound up requiring medical attention.

"All medications have risks … and that's no less true of cough and cold medications than any other category," said Gerry Harrington, a spokesperson for the Nonprescription Drug Manufacturers Association of Canada.

A physician with the Canadian Paediatric Society's drug therapy committee says there is growing concern about the potential dangers the drugs pose.

"Because of what they are used for, the symptomatic relief of common cold, any risk is unacceptable. So risk of death would be unacceptable in babies," said Dr. Michael Reider.

"Let's send a clear message: it won't make them feel better and there may be some risk. Don't use it."

U.S. drug regulators are reviewing the safety of cough and cold remedies. In a written statement, Health Canada said it's aware of the American review and is conducting its own assessment of the safety of these products.

Canada's non-prescription drug industry has confirmed it will change its labelling to warn against use in children under the age of two, but says it wants more study into the issue.

Reider said he'd like to see other changes to advertising imagery.

"So that the manufacturers do not show pictures of little babies, because it gives the impression they are safe and effective," said Reider.

Earlier this year, the U.S. Centers for Disease Control and Prevention advised parents against giving over-the-counter cough or cold medicines to children under two years old.

The American Academy of Pediatrics first advised parents in 1997 about the risks of complications and overdose potential with certain cough suppressants.