The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued.
The warnings cover the following products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (discontinued). According to the company, the currently marketed Zicam products constituted 40% of its net sales in 2009. According to FDA, nearly 130 consumers over the past 10 years have reported a loss of smell (anosmia) after using these three Zicam products, allegedly due to the fact the products contain zinc.
“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 (CDER). “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.”
Although the company admits it has received a Warning Letter for failing to file a new drug application for its Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs, Matrixx released a statement saying it “believes these products are safe and do not cause anosmia. The Company’s position is supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.” According to the statement, Matrixx Initiatives “believes the FDA action is unwarranted and is in the process of determining a response.”