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Zicam is a branded series of products marketed for cold and allergy relief whose original formulations included the element zinc. The Zicam name is derived from a portmanteau of the words "zinc" and "ICAM-1" (the receptor to which a rhinovirus binds in order to infect cells).[citation needed] It is labelled as an "unapproved homeopathic" product.[1]

Zicam was invented by Robert S. Davidson and Charles B. Hensley in the mid 1990s and is produced, marketed and sold by Zicam, LLC, a wholly owned subsidiary of Matrixx Initiatives, Inc.,[2][3] an American over-the-counter drug company. In 2009, the U.S. Food and Drug Administration (FDA) and Health Canada advised consumers to avoid intranasal versions of Zicam Cold Remedy because of a risk of damage to the sense of smell,[4] leading the manufacturer to withdraw these versions from the U.S. market.[citation needed] The Zicam brand has been expanded to include non-zinc formulations.[citation needed]

Ingredients and use

The only biologically active ingredients present in Zicam Cold Remedy are slightly diluted zinc acetate (2X = 1/100 dilution) and zinc gluconate (1X = 1/10 dilution);[1] the product's other originally active ingredients have been serially diluted to the point that Zicam should no longer contain any molecules of those ingredients, and are listed as "inactive ingredients" on the label.[1]

Zicam is marketed as a homeopathic product that can shorten the duration of a cold and that may reduce the severity of common cold symptoms, like sore throat, stuffy nose, sneezing, coughing and congestion.[citation needed] It is marketed in accordance with the Homeopathic Pharmacopoeia of the United States, and its cold reduction claims are supported by various clinical studies: Center of Integrative Medicine,[5] Department of Infections Diseases, Cleveland Clinic Foundation, Cleveland OH.[6] Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca,[7] histamine dihydrochloride (homeopathic name, histaminum hydrochloricum),[8] luffa operculata,[9] and sulfur.

Safety concerns

Litigation

In 2006, Matrixx Initiatives paid $12 million to settle 340 lawsuits from Zicam users who said that the product destroyed their sense of smell[4] (medically termed anosmia), although the company did not admit fault.[10] As of 2009, "hundreds more such suits have since been filed."[4]

NAD Claims

In April 2013, the National Advertising Division recommended that Matrixx initiatives cease advertising claims suggesting "its homeopathic Zicam Cold Remedy products prevent users from catching a cold."[11] However, the NAD concluded that imagery of the “cold monster” was unlikely to imply that taking Zicam would, in fact, reduce the severity of a cold. The advertiser’s voluntary discontinuance of the language “concentrated formula” from its Zicam ULTRA advertising and product packaging was noted and appreciated. It was found that Zicam provided a reasonable basis for the use of “Ultra” for Zicam products that contain more of the active ingredient per dosage unit than their original counterparts and require consumers to take fewer doses per day.[11]

FDA warning and product recall

On June 16, 2009, the FDA advised consumers to discontinue use of three nasally administered versions of Zicam Cold Remedy—Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (a discontinued product)—because the FDA had associated a serious risk of anosmia with them.[12] The advisory did not implicate other Zicam products. The FDA indicated that it had received reports of a loss of smell from approximately 130 Zicam Cold Remedy users since 1999.[12] The FDA voiced concern that the loss of smell may be long-lasting or permanent, while the condition for which these Zicam products are marketed—the common cold—typically resolves on its own without lasting problems.[13] The manufacturer stated that it had received an additional 800 reports of a loss of smell, but did not turn those over to the FDA as they did not feel they were required to do so.[14][15][16] The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam Cold Remedy.[15]

The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval.[15] The company initially refused to recall the products[17] but later said that they would withdraw the products from sale and that, "based on the FDA’s recommendation, consumers should discard any unused product or contact Zicam ... to request a refund."[18] On June 24, 2009, Matrixx recalled all affected products.[19] The company maintained that most cases of anosmia are due to the common cold itself, and that complaints of anosmia among Zicam Cold Remedy users are unlikely to be more numerous than those expected among the general population.[18] In contrast, the FDA had reported that cases of anosmia associated with intranasal Zicam Cold Remedy products were in excess of those seen with other nasal remedies for the common cold, and that cases associated with intranasal zinc presented more rapidly, and with different symptoms, than did unrelated cases.[13][15]

In addition, the FDA's warning letter prompted the Securities and Exchange Commission to investigate the company.[19] Through Freedom of Information Act (FOIA) filings, Matrixx has requested the FDA to provide the research and evidence that led them to request the withdrawal of Zicam swabs. The company said that "fundamental fairness" required a clear explanation of the FDA's methodology and analysis.[20]

On June 19, 2009 Health Canada, in a foreign product alert, also issued a similar warning based on the U.S. FDA information.[21]

References

  1. ^ a b c Zicam: Label data, National Institutes of Health
  2. ^ Matrixx Corporate Page
  3. ^ Gorman, Christine (November 15, 1999). "Block That Cold!". Time.
  4. ^ a b c Harris, Gardinier (June 16, 2009). "FDA Warns Against Use of Zicam". New York Times.
  5. ^ http://www.ncbi.nlm.nih.gov/pubmed/11055098
  6. ^ http://qjmed.oxfordjournals.org/content/96/1/35.long
  7. ^ A Homoeopathic Proving of Galphimia glauca
  8. ^ Description of Histaminum Hydrochloricum
  9. ^ Luffa operculata L. COGN Sponge Cucumber
  10. ^ "Homeopathic medicine company fights off Zicam lawsuits". USA Today. August 1, 2007.
  11. ^ a b “NAD Recommends Matrixx Discontinue Claims that Suggest ‘Zicam’ Products Protect Users from Catching Cold; Found Advertiser Could Support Certain Claims”. Advertising Self-Regulatory Council, April 5, 2013.
  12. ^ a b "FDA Advises Consumers Not To Use Certain Zicam Cold Remedies: Intranasal Zinc Product Linked to Loss of Sense of Smell". U.S. Food and Drug Administration. June 16, 2009.
  13. ^ a b "Zicam Fact Sheet". U.S. Food and Drug Administration. June 16, 2009. Retrieved June 20, 2009.
  14. ^ Matrixx Said It Didn’t Give 800 Zicam Reports to FDA (Update1)
  15. ^ a b c d Autor, Deborah M. (June 16, 2009). "Warning Letter, FDA Director of Compliance to Matrixx Initiatives, Inc. AKA Zicam LLC".
  16. ^ Des Moines Register, June 20, 2009, page 16A.
  17. ^ F.D.A. Warns Against Use of Popular Cold Remedy, New York Times, June 16, 2009
  18. ^ a b "Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel". Matrixx Corporation. June 16, 2009.
  19. ^ a b "Matrixx recalls Zicam nasal cold products". Associated Press. June 24, 2009. Archived from the original on June 25, 2009.
  20. ^ Matrixx again asks FDA to rescind Zicam warning, Matrixx Initiatives, in The Arizona Republic, November 19, 2009
  21. ^ Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size - Foreign Product Alert

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