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U.S. Department of Health and Human Services

Drugs

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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.