FDA Warning | Matrixx Initiatives | Zicam Cold Remedy Gels and Swabs

FDA Warning Letter Alert:  Matrixx Initiatives Issued FDA Warning Letter Regarding  Zicam Cold Remedy Gels and Swabs | Intranasal Zinc Product Linked to Loss of Sense of Smell

On June 16, 2009, the FDA issued a press release and warning letter advising consumers to stop using three products marketed over-the-counter by Matrixx Initiatives as cold remedies because they are associated with the loss of sense of smell (anosmia):  Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

The FDA reported that it had received more than 130 complaints and reports of loss of sense of smell associated with the use of these three Zicam products.  In these complaint reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) was quoted as saying that “Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,”  and she continued that “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.”

According to the FDA, people who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional since the loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA warning letter advised Matrix Initiatives to stop marketing these Zicam products without FDA approval.