Over-the-counter children’s cough and cold medications will be relabeled in Canada to indicate that they should not be used in children under 6 years of age. However, in the United States, the drug makers only agreed to limit use of the medications among children under 4, despite calls from consumer groups that the age limit should be set at 6, due to the potential risk of adverse health effects.
The children’s cough and cold drugs include over 800 popular products marketed without a prescription, such as Pediatric Tylenol, Triaminic, Dimetapp, Vicks, Little Noses and Pediacare.
Side effects of the children’s cough and cold drugs have been associated with reports of hallucinations, suppressing respiratory systems, increasing heart rates, and a potential increased risk of strokes and seizures.
Health Canada, which is the drug regulatory agency in Canada, indicates that they are requiring the manufacturers of these cough and cold medicines for children under 12, to retable their products in Canada to indicate that they should not be used in children under 6.
“Health Canada has concluded that while cough and cold medicines have a long history of use in children, there is limited evidence supporting the effectiveness of these products in children,” said the government health agency in a statement released December 18, 2008. “In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under 6.”
Earlier this year, the makers of the over-the-counter children’s cough and cold drugs resisted calls in the United States by consumers advocacy groups and experts urging a ban on the use of the drugs by children up to 6 years old.
On October 7, 2008, the Consumer Healthcare Products Association, which is an industry trade group representing the pharmaceutical industry, announced that they were voluntarily changing the labels of the children’s drugs to indicate that they should not be used in children under 4. The FDA then released a statement that they support the decision by the drug industry.
Public Citizen, which is a prominent consumer group that has been calling for a 6 year age limit in the United States, indicated that the decision to only limit use in children under 4 in the United States was not based on scientific evidence, but instead a political compromise between the age limit of 6 urged in a petition filed last year, and the limit of 2 which the drug industry had on the medications at that time.
The market for over the counter children’s cough and cold drugs is a big industry, with over 800 products available to treat coughs, sore throats, runny noses and fevers. Nearly 100 million packages of oral cough and cold drugs for children are sold every year, generating over $311 million in sales.