Consumers should immediately stop taking zinc-based intranasal Zicam cold products and discard them or return them to stores because they damage the sense of smell, the Food and Drug Administration said Tuesday.
The agency ordered the products' manufacturer, Matrixx Initiatives of Scottsdale, Ariz., to stop marketing the products and said it would work with the company for their removal from store shelves.
In light of the health risks, if the company wants to market the products in the future, it would have to receive FDA approval for them just as it would for prescription drugs, said Deborah M. Autor, director of the office of compliance for the FDA's Center for Drug Evaluation and Research. The products, like other over-the-counter supplements, did not initially require such approval.
The loss of smell can be "life-threatening," Autor said, because people with impaired smell cannot detect leaking gas or smoke and cannot tell if food has spoiled before they eat it.
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The products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. The last product has been discontinued, but many consumers might have it in their medicine cabinets, Autor said.
The agency has received more than 130 reports of anosmia — loss of the sense of smell — associated with use of the products, she said. "The damage can be temporary or permanent," she said.
An additional 800 such reports are believed to have been made directly to the company. Companies have been legally required to forward such reports to the FDA since 2007, but Matrixx has not done so, Autor said.