Zicam Warnings

Zicam Fact Sheet June 16, 2009

Reports of anosmia or loss of sense of smell associated with use of three zinc-containing intranasal Zicam products represent a strong and significant safety signal. Anosmia is a serious, disabling condition that may result in the permanent loss of one of the five senses, the sense of smell. Anosmia may be long-lasting or permanent.

These products are for the treatment of a condition that goes away on its own (common cold).

People with anosmia may not be able to smell smoke, a gas leak, or spoiled food. Additionally, anosmia is often associated with a loss of sense of taste (ageusia).

Anosmia and ageusia may affect the work of people employed in the food industry, or other industries in which the sense of smell and taste are very important.

Zicam products that are the subject of the warning: Zicam Cold Remedy Nasal Gel (NDC 62750-003-10) Zicam Cold Remedy Swabs (NDC 62750-003-20) Zicam Cold Remedy Swabs, Kids Size (NDC 62750-003-21)

Zicam brands that are NOT affected by the warning: Zicam Cold Remedy RapidMelts with Vitamin C Zicam Cold Remedy RapidMelts Zicam Cold Remedy Oral Mist Zicam Cold Remedy Chewables Zicam Cold Remedy ChewCaps Zicam Cold Sore Gel Swabs Zicam Multisymptom Cold and Flu Liquid-Daytime Zicam Multisymptom Cold and Flu Liquid-Nighttime Zicam Multisymptom Cold and Flu To Go-Daytime Zicam Multisymptom Cold and Flu To Go-Nighttime Zicam Cough Max Cough Spray Zicam Cough Max Cough Melts Zicam Extreme Congestion Relief Nasal Gel Zicam Intense Sinus Relief Nasal Gel Zicam Healthy Z-ssentials Zicam Seasonal Allergy Relief Nasal Gel Zicam Seasonal Allergy Relief Gel Swabs

While Zicam also makes zinc-containing oral cold remedies, these are not subject to this warning because the development of anosmia appears to be related to the intranasal application of zinc. Post-viral anosmia has been noted in individuals (unrelated to zinc), however, anosmia with intranasal zinc presents differently; many individuals complain of burning or stinging sensations in the nose and a more rapid onset of symptoms than is seen with post-viral anosmia. FDA’s concerns about reported adverse events of anosmia are heightened by published scientific literature that provides evidence supporting the connection between intranasal zinc and anosmia.

www.fda.gov

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