The US Food and Drug Administration has warned consumers to stop using three Zicam Cold Remedy products because those products have been linked to potentially serious Zicam side effects, including, reportedly, the loss of the sense of smell (known as anosmia). The reported Zicam smell loss apparently can occur within a few uses of the Zicam Cold Remedy products. Products linked to the Zicam loss of smell in the FDA's advisory are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (this last product has been discontinued).
Zicam Smell Loss
The products named in the FDA's advisory are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size (a discontinued product).
“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.”
Zicam is an over-the-counter nasal solution and cold remedy that is applied either by spraying or swabbing the product directly onto the nasal surface. Patients reportedly complained about an intense burning sensation in their nasal cavity immediately after using the Zicam product. This was followed by a loss of the sense of smell after the cold symptoms cleared up. Anosmia is also linked to a decrease in the ability to taste.
In addition to decreasing quality of life, loss of sense of smell can be dangerous for people. Some signs of danger include the smell of gas or smoke, which people with anosmia would not be able to detect. Furthermore, patients who work in the food industry or who rely on the senses of small and taste for their employment could find their work affected by anosmia.
Zicam Loss of Smell
The UPSIT test is a universally accepted test to determine olfactory dysfunction and is designed to identify subjects who may exaggerate their smell disability. Physicians can also perform tests to determine the degree of deterioration of a patient's olfactory system.
Patients who suffered a permanent loss of smell, either fully or partially, should have a test done to prove anosmia—either the UPSIT test or a test provided by a physician.
Zicam is manufactured by Matrixx. Matrixx's line of products includes Zicam Cold Remedy, Zicam Allergy Relief, Zicam Maximum Strength Flu and more. The FDA has sent Matrixx a warning letter, advising the company that these products cannot be marketed without FDA approval. Matrixx has countered the FDA's warning saying there is no well-controlled scientific study to determine cause-and-effect between use of Zicam and problems with the sense of smell.
Not all Zicam-brand products were affected by the FDA's warning. Products that are taken orally have not been linked to anosmia, nor have products that do not contain zinc. Only those that have an intranasal application and contain zinc are cited by the FDA as a potential risk.
According to Matrixx's 2009 annual report, the company entertained settlement discussions regarding claims related to the single hole pump product. That product has not been on store shelves since around 2005 and had an expiry date of 2008. Patients who used any intranasal Zicam product that contained zinc and suffered permanent loss of sense of smell may be eligible to file a lawsuit against Matrixx.
Since the FDA's warning letter was sent, Matrixx has stopped selling Zicam in an intranasal format. Zicam cold remedies are now available in oral formats.