The US Food and Drug Administration has warned consumers to stop using three Zicam Cold Remedy Products after the products were linked to the loss of the sense of smell (anosmia). The FDA made the announcement after receiving more than 130 reports of anosmia linked to the products. The onset of Zicam smell loss varied, with some patients reporting it after the first dose of cold remedy, while others reported the condition after multiple uses of the product.
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 FDAs 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.
Patients who think they have been harmed by use of Zicam require a diagnosis of anosmia. The University of Pennsylfania Smell Identification Test (UPSIT) can be done at home by patients who are concerned they have lost their sense of smell. The test involves four booklets containing odors in a "scratch-and-sniff" form. The patient is asked to smell each odor and identify, through multiple-choice format, each smell. Scores on the test can indicate the degree of damage to the olfactory system. An UPSIT test can be ordered online and usually costs between $30 to $50.
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 anosmiaeither the UPSIT test or a test provided by a physician.
Zicam contains the active ingredient Zincum Gluconicum (also known as Zinc Gluconate). This active ingredient has been linked to nasal nerve damage and is believed to cause a caustic action on the nasal passages that leads to a loss of the sense of smell.
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.
Zicam Loss of Smell Legal HelpIf you or a loved one has suffered the loss of smell after using Zicam, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please fill out the form to submit your complaint.
Last updated on Nov-26-12