The Food and Drug Administration today issued a warning to consumers to discontinue the use of the nasal cold remedy Zicam because it may result in the loss of smell. The products are:
–Zicam Cold Remedy Nasal Gel
–Zicam Cold Remedy Nasal Swabs
–Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
While Matrixx Initiatives, manufacturers of Zicam, maintains that their product is safe, as a result of the F.D.A warning, they issued a press release today stating they are voluntarily recalling all Zicam products.
The F.D.A. has received rover 130 reports of anosmia, or loss of smell, from consumers with as little as one dose of the nasal gel. The reports date back to 1999 and include both temporary and permanent loss of smell.
Zicam isand is distributed as a homeopathic remedy. As such, they did not need approval from the F.D.A. to sell the product. However, according to the New York Times, Matrixx has settled over 340 claims totalling over $12 million for loss of smell and has over 800 reports of loss of smell but F.D.A. has not seen those reports.
According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER)
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms. 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.”
Matrixx has asked consumers to discard any unused product or request a refund online at www.ziam.com or by calling 1-877-942-2626.