The Division of Drug Information (DDI) serves the public by providing information on human drug products and drug product regulation by FDA.
FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia). These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.
This advisory does not concern oral zinc tablets and lozenges taken by mouth.
FDA recommends that consumers stop using these products and throw them away. See the FDA website for How to Dispose of Unused Medicines at www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm.
For treating symptoms of the common cold, consumers can take a number of other over-the-counter drugs. However, the common cold goes away without treatment, usually within seven to ten days.
Since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. The reports vary. Many people state that the loss of sense of smell occurred with the first dose of the Zicam product, although some people report it happened after later doses. The loss of sense of smell may be long-lasting or even permanent in some people.
Loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. Also, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.
FDA recommends that consumers contact their healthcare provider if they experience loss of the sense of smell or taste, or experience other problems after using any zinc-containing nasal products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/index.html.
For more information, please visit: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm.
If you have comments or questions, please contact: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email druginfo@fda.hhs.gov.
For additional drug information, please visit the DDI Web page: www.fda.gov/AboutFDA/CentersOffices/CDER/ucm082585.htm.