FDA Issues Warning on Three Zicam Products

The cold remedies appear to be associated with a loss of the sense of smell
By Andrea Mongler
HealthDay Reporter

TUESDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) has warned consumers to stop using three over-the-counter cold remedies because they may cause a loss of the sense of smell, or anosmia, according to an FDA news release issued June 16.

The three products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs: Kids Size (a discontinued product). Matrixx Initiatives is the maker of all three products, and the FDA has warned the company that it cannot market them without the agency's approval.

The FDA has received more than 130 reports of anosmia linked to the use of the three products. Some consumers reported losing their sense of smell after using one of the products a single time. Anosmia can be long lasting or even permanent.

"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in Silver Spring, Md. "We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."

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