FDA Issues Warning Over Matrixx Intiatives’ Zicam
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.”
My family (young son and very elderly mother) and I have used Zicam swabs since they were introduced. We use them AS DIRECTED and have never experienced any problems. Used as directed, the swab does not touch the more sensitive upper nasal membrane. I would be very interested to know if the persons experiencing the anosmia has used the
product(s) following the explicit directions accompanying Zicam products or if this is yet another result of persons not following dosing instructions.
I would be dismayed if this product were to stop being sold as it certainly has helped us remain on the plus side of weathering seasonal colds.
I have used Zicam nasal gel spray and swabs for colds for the past 7-8 years. I have always followed the directions for use on the package. During that time, I have not experienced any loss of smell or taste, either during or following use of the product. In fact, I can confidently report that both senses are acute and intact. The product has been extremely effective in reducing the length and severity of cold symptoms and has hugely improved my feelings of health and well-being when I have the common cold. I have recommended this product to many people, and no one has ever mentioned any adverse reaction after use. I have written to the FDA, urging them to allow continued marketing of Zicam nasal gel products; if appropriate, a warning could be placed on the package. In my opinion, after long-term, occasional use of this very effective therapy, the benefits far outweigh the risks.
Thank you for your comments. As an update, the company has announced that it will voluntarily withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Nasal Gel. Matrixx Initiatives have agreed to comply with FDA requirements and is seeking a meeting with the agency. The company insists there is no causal link between its Zicam Cold Remedy intranasal products and anosmia, and it reports more than 1 billion doses have been sold since 1999.
Frequently asked questions about the recall are now posted at:
http://www.zicam.com/FDAwarningletterfaq