Health Canada is warning parents not to give cough and cold medication to children under six-years-old.

"Based on (our) review, we have come to the conclusion that these products should not be used in children under the age of six," Dr. Marc Berthiaume of Health Canada told CTV News.

Officials have found very few studies that prove cough and cold products work effectively on children. Meanwhile, the numbers of children harmed by medication overdoses and by rare side effects has risen.

Over the course of a 13-year period, Canadian officials received reports of 164 negative reactions from children who were given cough or cold remedies.

Those reactions included heart problems, hallucinations and convulsions.

More troubling, five deaths have also been linked to various cold and cough products.

"The recommendation not to give cough and cold remedies to children under six is reasonable and we agree," said Dr. Michael Rieder of the Canadian Pediatrics Society.

Still, drug makers have said they will conduct their own studies on the effectiveness of their products on children.

Gerry Harrington of the Non-Prescription Drug Manufacturing Association of Canada said the cold drugs have a good "track record" and that the medications "do have value" for kids.

Last year, the agency recommended that cough and cold medication shouldn't be given to children under two, unless directed to do so by a health care practitioner.

In a press release Thursday, Health Canada said it is raising the age limit after having conducted further analysis of available information.

The statement listed the following reasons for increasing the cut-off age:

  • Recommendations from Canadian and international health professionals and experts that these medicines should not be used in children under 6;
  • Body weight and its affect on how medicines work. Some children between the ages of 2 and 6 years may weigh the same as other children who are less than two years old, the most vulnerable group;
  • Children under the age of 6 years generally have more colds compared to older children and therefore, are likely to be exposed more frequently to these medications; and
  • Younger children are less likely to be able to communicate a potential side-effect from a cough and cold medicine and to ask their parents/caregivers for help in the same way a child over the age of 6 can.

In light of the decision, manufacturers must now show the age warning on all cough and cold medicines for children. They have until fall 2009 to update the labels.

The products must also have "enhanced labelling" for children ages 6 to 12, child resistant packaging, and dosing devices for liquid formulas.

The agency is also reminding parents that the common cold is a viral infection for which there is no cure.

"Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion," says the release.

"Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity."

With a report from CTV medical specialist Avis Favaro