Health Canada issues advisory on cough meds in kids under 2

Last Updated: Thursday, October 11, 2007 | 9:25 PM CT

CBC News

In the wake of a U.S.-led recall of infant cough and cold medicines, Health Canada issued an advisory Thursday warning consumers not to give over-the-counter cough and cold medications to children without first consulting a doctor.

"Before using over-the-counter cough and cold remedies in children under two years of age, Health Canada urges caregivers to consult a health-care practitioner to assure that their use is safe and appropriate," reads the release.

"Many of these products contain the same medicinal ingredient(s), and giving more than one product with the same ingredient or multiple doses of the same product could lead to an overdose."

On Sept. 28, the U.S. Food and Drug Administration issued a more strongly worded advisory, warning consumers that children under the age of two should not use decongestants and those under age six should not be given antihistamine medicines.

Health Canada's announcement follows the recall of three infant cough and cold medicines in Canada because they pose overdose risks.

The Canadian recall, announced Thursday, applies to Johnson & Johnson's McNeil Consumer Healthcare products as follows:

• Infants' Tylenol cold dye-free drops.
• Benylin for infants cough and cold oral drops.
• Benylin for infants stuffy nose oral drops.

Earlier in the day, Johnson & Johnson's McNeil Consumer Healthcare subsidiary, along with Novartis and Prestige Brands Holdings, said they were pulling oral infant medications from U.S. store shelves.

Johnson & Johnson said in a statement Thursday that "rare instances of misuse" may lead to overdoses in children under the age of two.

The wider U.S. recall also includes:

• Concentrated Infants' Tylenol Drops Plus Cold.
• Concentrated Infants' Tylenol Drops Plus Cold & Cough.
• Pediacare Infant Dropper Decongestant.
• Pediacare Infant Dropper Long-Acting Cough.
• Pediacare Infant Dropper Decongestant & Cough.
• Dimetapp Decongestant Plus Cough Infant Drops.
• Dimetapp Decongestant Infant Drops.
• Little Colds Decongestant Plus Cough.
• Little Colds Multi-Symptom Cold Formula.
• Robitussin Infant Cough DM Drops.
• Triaminic Infant & Toddler Thin Strips.
• Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

Cough and cold medicines intended for children aged two and older are not included in the recall.

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.

Many pediatricians discourage the use of cough and cold medications for infants, said Dr. Michael Peer of Toronto's Hospital for Sick Children. He noted that dosing studies are largely more for adults than children.

"Pediatricians in general really don't feel that most of the cough and cold medications have any role in treating a child with a cough and a cold and the main reason is they're just not very effective," Peer said.

"We know that the majority of children with coughs and colds have viral infections and there's really not much we can do to treat those infections."

Peer said as cough and cold medications generally don't speed up recovery, parents and children should allow the cold to run its course.

U.S. study probes dangers of infant cold medicines

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 is also expected to adjust labels to reflect safety concerns. 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.

U.S. drug manufacturers are pulling cough and cold medications for infants because of possible overdose dangers.
(CBC)

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

The U.S. Food and Drug Administration said in a report released in late September that children under the age of two should not use decongestants and those under age six should not be given antihistamine medicines.

The FDA also said warning labels should be added to prescription and over-the-counter cough and cold medicines, cautioning parents about potential overdose risks for toddlers.

With files from the Associated Press