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Canadian Zicam Warning

Jun 18, 2009 | Parker Waichman Alonso LLP

Canadian health regulators are now warning consumers there not to use three Zicam nasal cold remedy products. The Health Canada Zicam alert comes just days after the Food & Drug Administration (FDA) warned consumers in the U.S. not to use the same three Zicam products because of reports linking them to anosmia - loss of sense of smell - in some people.

Matrixx Initiatives, the maker of Zicam, has since recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named in the FDA alert.

Zicam products are popular over-the-counter nasal cold remedies. Zinc gluconate, the active ingredient in Zicam products, has long been believed to produce a caustic action on the nasal passages that, over time, can lead to a loss of smell.  Because they are considered homeopathic remedies, they did not require FDA approval.  However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers.

Earlier this week, the FDA said it had received 130 reports of anosmia in people who had used the three Zicam nasal remedies.  During a conference call to announce the Zicam alert, the FDA also said Matrixx had received an additional 800 reports it hasn’t made available to the agency. The FDA said that many people who experienced a loss of sense of smell say that the condition occurred with the first dose of Zicam, although some people have reported loss of sense of smell after later doses. The FDA said it was concerned that the loss of sense of smell may be permanent.

In addition to the FDA alert, Matrixx was issued a warning letter by the agency informing it that it could not market the Zicam products without FDA approval.  The company was also cited for not including adequate warnings about the risk of anosmia associated with the Zicam Nasal cold remedies.

Now Health  Canada is issuing a similar Zicam warning.  The Zicam products named in the FDA alert are not authorized for sale in Canada, but Health Canada said they may have been brought into the country by travelers or purchased over the Internet.   Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the Zicam nasal products in the Canadian marketplace.