Health Canada is considering changing the rules on selling and labelling children's cold medications that have been linked to serious complications and at least three deaths among children under the age of two between 1995 and 2007, according to confidential documents obtained by CBC News under federal Access to Information laws.
Chantal Hubert of Almonte, Ont., for example, turned to over-the-counter cold medicine for her congested son, Alex, when he was18 months old.
|Pediatric cough and cold medicine adverse drug reports 1995 to 2007|
|Active ingredient||Type of medicine||Number of cases|
|Source: Josephine Djulus and Melissa Hunt, Health Canada briefing document to scientific advisory panel on nonprescription pediatric cough and cold medications|
"We gave him the infant's cold medication that we got over the counter," the mother of four recalled. "Within about 45 minutes, he was jittery, he couldn't settle down. He seemed a little bit far off, he was not at all happy."
The internal report from Health Canada received by the CBC suggested that Alex's reaction was mild compared with those experienced by many other Canadian children.
Between 1995 and 2007, there were 145 cases of reactions, 92 that were considered serious — including two infants who died from an accidental overdose, and a third infant who had a complicated medical history and was taking other drugs.
Of the 145 reactions, 110 resulted after taking the recommended dosage.
The adverse event reporting system is voluntary, and it is difficult to determine the cause in each case.
But the reported reactions are likely the tip of the iceberg. Medical experts said for every case reported as many as 100 more go unreported.
Cough and cold medications for children under two have been voluntarily withdrawn from the Canadian and U.S. markets within the past year. Now a Health Canada panel is considering whether the products should be marketed to children under 12.
|Sample of other pediatric over-the-counter adverse drug reports for children 12 and under, 1995 to Present|
|Drug||Type of medicine||Number of cases|
|Children's Advil||Fever||7 suspected|
|Acetaminophen||Pain relief, fever||4|
|Children's Tylenol||Pain relief, fever||13|
|Children's Benadryl Allergy||Antihistamine||0|
|Source: Health Canada|
"So basically all of the chemical ingredients, whether it's a cough suppressant, whether its an antihistamine, you know whether it's a nasal decongestant — none of those agents in children have any evidence that they work," said Dr. Michael Rieder, a pediatric pharmacologist in London, Ont., and a spokesman for the Canadian Pediatric Society.
"Meta analysis says that there is not strong evidence that these products work" in young children, said Gerry Harrington, director of public affairs for the Nonprescription Drug Manufacturers Association of Canada. "It's mainly because of the lack of studies that have been done, very small number of studies done, and very flawed studies."
The pharmaceutical industry is sponsoring clinical trials in which cough and cold medications will be tested in children, Harringon said. The results of those tests won't be available for at least two years. In the meantime, the association advises parents with older children to read the labels carefully, saying children's cough and cold products are safe when used properly — a key issue the group wants Health Canada to consider.
"Two things we think are very likely to be part of the package is the provision of accurate dosing devices with these products, as well as uniform child-resistant packaging," Harrington said, noting those two issues are important causes of the rare adverse-events.
A spokesperson for Health Canada said the department will make the results of its assessments on the use of cough and cold products in children aged two to 12 available "in due course."
Hubert isn't waiting for Health Canada's decision or the research.
"We have pretty much gone back to our old standby, which is exactly what my mother used to do," said Hubert. "Lots of rest, lots of fluids, just basically taking it easy until you feel better, and recognizing that should you feel worse and not start to feel better in a few days, maybe go to your doctor."