Don't give cold and cough medications to children under the age of six, Health Canada advised Thursday after reviewing the effectiveness and potential dangers of the drugs.

 

 Health Canada's advice until products are relabelled
  • Do not use these over-the-counter cough and cold medicines in children under six years of age.
  • With children older than six, always follow all the instructions carefully, which includes the dosing and length-of-use directions, and use the dosing device if one is included.
  • Do not give children medications labelled only for adults.
  • Do not give more than one kind of cough and cold medicine to a child to prevent overdoses.
  • Talk to your health-care practitioner if you have questions about the proper use of over-the counter cough and cold medicines.
  • The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms.
  • For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.
  • If symptoms worsen, last for more than a week or are accompanied by a fever higher than 38 C or the production of thick phlegm, see a health-care practitioner.

"Given the number of adverse events that have been reported, especially in children under the age of six, Health Canada has decided that from now on these products should no longer be recommended," Dr. Marc Berthiaume, director of the marketed pharmaceuticals and medical devices bureau at Health Canada, said from Ottawa.

The department has warned parents about giving the medications to children under the age of two.

Health Canada is expanding the restriction to age six because it received 124 reports of adverse reactions, 80 of them serious, in children under six from January 1995 to 2008.

Of these, five children under age two who were taking the medications died, although it has not been confirmed that misuse or overdose of the products was the cause, Berthiaume said.

Other rare side-effects included convulsions, increased heart rate, and hallucinations.

No labels for fall cold season

There was also no evidence of benefit from the medications, and cold symptoms get better on their own with time, Health Canada said in the advisory posted on its website.

Last year, a review by the U.S. Food and Drug Administration also turned up 54 deaths related to decongestants, and another 69 from antihistamines dating back to 1969.

It used to be common practice to give the medications, said Cindy Landles, a daycare provider in Winnipeg. Since the first warning was given, many parents chose to let their children fight off colds on their own or under the care of a family doctor.

"Right now we have no children taking cough medicine, and we haven't actually all winter," Landles said.

A spokesperson for the pharmaceutical industry said they stand by the products, and noted that better studies are needed to try to convince Health Canada officials about the safety.

"We certainly accept that technology has advanced now that we can do these studies in young children and so those studies are going forward," said Gerry Harrington, director of public affairs for the Nonprescription Drug Manufacturers Association of Canada in Ottawa.

New labels on cough and cold medications should be completed by the fall of 2009, Health Canada said.

In the meantime, the medications should not be used without consulting a pharmacist or health-care practitioner, it advised.

With files from Canadian Press