Zicam

Zicam
Website http://www.zicam.com/

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).[1] It is labelled as an "unapproved homeopathic" product.[2]

Zicam was invented and developed by Charles B. Hensley and Robert Steven Davidson in the mid 1990s and is produced, marketed and sold by Zicam, LLC, a wholly owned subsidiary of Matrixx Initiatives, Inc.,[3][4] an American 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,[5] leading the manufacturer to withdraw these versions from the U.S. market. However, in recent years, they have returned to market with both a form of the original nasal swabs and also dissolving/chewable tablets and nasal spray forms.

Ingredients and use

Because this product is not a drug, nor is it a food and therefore cannot be regulated, all claims by its manufacturer must accompany the disclaimer "this product has not been evaluated by the food and drug administration." All information marked as "ingredients" are claimed only; there is no way to discern what is actually in the product. The only biologically active ingredients present in Zicam Cold Remedy are zinc acetate (2X = 1/100 dilution) and zinc gluconate (1X = 1/10 dilution).[2] Other sources list the ionic zinc content as "33 mmol/L of zincum gluconium".[6]

Zicam is marketed as a homeopathic product which the maker claims can shorten the duration of a cold and may reduce the severity of common cold symptoms.[7] It is marketed in accordance with the Homeopathic Pharmacopoeia of the United States, a private organization not linked to nor regulated by any part of any government, and its cold reduction claims are claimed to be supported by various non-scientific private studies done by and for the homeopathic industry: Center of Integrative Medicine,[8] Department of Infections Diseases, Cleveland Clinic Foundation, Cleveland OH.[9] Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca[10] histamine dihydrochloride (homeopathic name, histaminum hydrochloricum),[11] luffa operculata,[12] 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[5] (medically termed anosmia), although the company did not admit fault.[13] As of 2009, "hundreds more such suits have since been filed."[5]

In 2005, the International Brotherhood of Electrical Workers pension fund sued Matrixx Initiatives for misrepresenting the stock by not reporting the risks of Zicam.[14] In Matrixx Initiatives, Inc. v. Siracusano, the U.S. Supreme Court ruled that the union's suit could go forward.[15]

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."[16] 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.[16]

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.[17] 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.[17] 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.[18] 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.[19][20][21] The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam Cold Remedy.[20]

The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval.[20] The company initially refused to recall the products[22] 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."[23] On June 24, 2009, Matrixx recalled all affected products.[24] 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.[23] 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.[18][20]

In addition, the FDA's warning letter prompted the Securities and Exchange Commission to investigate the company.[24] 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.[25]

On June 19, 2009, Health Canada, in a foreign product alert, also issued a similar warning based on the U.S. FDA information.[26]

References

  1. ↑ Our Story
  2. 1 2 Zicam: Label data, National Institutes of Health
  3. ↑ Matrixx Corporate Page
  4. ↑ Gorman, Christine (November 15, 1999). "Block That Cold!". Time.
  5. 1 2 3 Harris, Gardinier (June 16, 2009). "FDA Warns Against Use of Zicam". New York Times.
  6. ↑ Bruce W. Jafek, M.D., Miriam R. Linschoten, Ph.D., and Bruce W. Murrow, M.D., Ph.D. Anosmia after Intranasal Zinc Gluconate Use. American Journal of Rhinology May-June 2004, Vol. 18, No. 3 pp137-141
  7. ↑ Associated Press (16 June 2009). "Nasal spray can cause loss of smell, FDA warns". NBC News. Retrieved 16 October 2014.
  8. ↑ Hirt, M; Nobel, S; Barron, E (Oct 2000). "Zinc nasal gel for the treatment of common cold symptoms: a double-blind, placebo-controlled trial.". Ear, nose, & throat journal 79 (10): 778–80, 782. PMID 11055098.
  9. ↑ Mossad, S.B. (1 January 2003). "Effect of zincum gluconicum nasal gel on the duration and symptom severity of the common cold in otherwise healthy adults". QJM 96 (1): 35–43. doi:10.1093/qjmed/hcg004. PMID 12509647. Retrieved 1 August 2014.
  10. ↑ Teut, Michael; Dahler, Jörn; Schnegg, Christoph. "A Homoeopathic Proving of Galphimia glauca". Forschende Komplementärmedizin 15 (4): 211–217. doi:10.1159/000148825. Retrieved 1 August 2014.
  11. ↑ Description of Histaminum Hydrochloricum
  12. ↑ Luffa operculata L. COGN Sponge Cucumber
  13. ↑ "Homeopathic medicine company fights off Zicam lawsuits". USA Today. August 1, 2007.
  14. ↑ See Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167, 1169 (2009).
  15. ↑ No. 09-1156 (U.S. Mar. 22, 2011) (slip op.).
  16. 1 2 "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.
  17. 1 2 "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.
  18. 1 2 "Zicam Fact Sheet". U.S. Food and Drug Administration. June 16, 2009. Retrieved June 20, 2009.
  19. ↑ Matrixx Said It Didn’t Give 800 Zicam Reports to FDA (Update1)
  20. 1 2 3 4 Autor, Deborah M. (June 16, 2009). "Warning Letter, FDA Director of Compliance to Matrixx Initiatives, Inc. AKA Zicam LLC".
  21. ↑ Des Moines Register, June 20, 2009, page 16A.
  22. ↑ F.D.A. Warns Against Use of Popular Cold Remedy, New York Times, June 16, 2009
  23. 1 2 "Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel". Matrixx Corporation. June 16, 2009.
  24. 1 2 "Matrixx recalls Zicam nasal cold products". Associated Press. June 24, 2009. Archived from the original on June 25, 2009.
  25. ↑ Matrixx again asks FDA to rescind Zicam warning, Matrixx Initiatives, in The Arizona Republic, November 19, 2009
  26. ↑ Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size - Foreign Product Alert

External links

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