Zicam Nasal Products Linked to Loss of Smell

The FDA issued a consumer Advisory on June 16, 2009, to stop using over-the-counter Zicam cold and nasal products (Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids Size) since they have been linked to a lasting or permanent loss of smell (anosmia). The FDA has received more than 130 reports of loss of sense of smell associated with the use of zinc-containing intranasal Zicam cold remedy products. Reports show many people experienced a loss of smell with the first dose, while others reported the same problem after multiple uses of the products. In addition to the reports FDA has received directly from consumers, the FDA is aware that Matrixx Initiatives appears to have received more than 800 reports from consumers who have experienced anosmia. Consumers are urged to contact their health care provider if they experience the loss of smell or taste.

In a stern warning letter to the manufacturer Matrixx Initiatives on June 16, 2009, the FDA says the products were misbranded since there is no data establishing that the Zicam Cold Remedy intranasal products are safe and effective for the uses identified in the product labeling (reducing the duration and severity of cold symptoms). The company must identify specific steps to correct the violations within 15 business days.

In 2009, sales of Zicam products made up about 40% of Matrixx Initiatives' net sales.

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Click here to read FDA warning letter to Matrixx Initiatives

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