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Canada Limiting Cold Meds for Kids

Dec 19, 2008 | Parker Waichman LLP

Earlier this year, Health Canada recommended parents not give over-the-counter (OTC) cold medications to children under the age of two, citing evidence that there is limited effectiveness in this population of children, reported Reuters.  Now, Reuters is reporting that Health Canada raised the age to six over issues of misuse and overdosing problems.  Health Canada is that country’s federal health agency.

In the United States, the use of OTC cold and cough medicines in young children has been a point of concern for some time.  In October 2007, some drug makers removed infant versions of the medications off the market, including Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand; Pediacare, Dimetapp, and Little Colds brand products were also recalled.   Earlier this year, the U.S. Food and Drug Administration (FDA) issued a warning advising that OTC cold and cough medicines should not be given to children under two following a 2007 study conducted by the Centers for Disease Control and Prevention (CDC) found that between 2004 and 2005, 1,500 children under the age of two were injured by common OTC decongestants and antihistamines; a second study by FDA safety reviewers reached similar conclusions and that research revealed that from 1969 to 2006, at least 54 children died after taking OTC decongestants, and 69 died after taking OTC antihistamines.

Health Canada asked a scientific panel to review the OTC cold medicine and reported that the panel found reports of rare, but serious side effects associated with the medications in addition to the ongoing misuse and overdose issues, said Reuters.  "While the link between the adverse events and the products cannot be definitely proven by these reports, they are signs that Health Canada cannot ignore," the agency said in a statement, Reuters quoted.

This past October, manufacturers in the U.S. of OTC children’s cold medicines warned that the drugs should not be given to kids younger than four-years-old. Manufacturers also said they planned on expanding an educational campaign aimed at urging parental care in giving children cough and cold medicines.  Health Canada said it set the limit at six years of age partly because younger children generally come down with more colds and are, therefore, exposed to more medications, said Reuters.  In Canada, a group representing drug makers warned—also in October—that OTC oral cough and cold medicines should not be used in children under four due to risks of rare complications linked to inappropriate use, reported Reuters, which added that such drug makers continue to maintain that OTC cold and cough medicines are safe when used as directed.  Regardless, said Reuters, Health Canada confirmed manufactures must change their medication labels next year, and studies will continue on the proper dosing levels for children.

Meanwhile, this month’s U.S. announcement by the Consumer Healthcare Products Association on behalf of the industry, came less than a week after an FDA advisory panel met to discuss the safety of OTC children’s cold medicines, which have been tied to accidental overdoses and deaths in this country.  Several patient advocates pushed for a ban on the drugs during that meeting.


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