Consumers should immediately stop taking Zicam Cold Remedy nasal products and discard them or return them to stores because they damage the sense of smell, the Food and Drug Administration said Tuesday.
The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.
The agency also 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.
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 still might have it in their medicine cabinets, the FDA’s Deborah Autor said.
“Loss of the sense of smell is potentially life threatening and may be permanent,” said Dr. Charles Lee, of FDA’s compliance division. “People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house.”
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,” Autor 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.
The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.
Matrixx also has been the subject of an unknown number of lawsuits related to the issue. Many of them have been settled out of court, but the company noted on its Web site that “no plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”
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