Zicam

Last updated
Zicam
Typehomeopathic remedy
Inventor Charles B. Hensley and Robert Steven Davidson
Inception1990s (1990s)
ManufacturerZicam, LLC
Current supplierZicam, LLC
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] and as such has no evidence of effectiveness. [3] [4]

Contents

Zicam was invented and developed by Charles B. Hensley and Robert Steven Davidson in the mid 1990s, working on the ICAM-1 synthesis success of the Hafdua Laboratory in Haifa, Israel, under the direction of Mich Segal and Avram Satz, and is produced, marketed and sold by Zicam, LLC, a wholly owned subsidiary of Matrixx Initiatives, Inc., [5] [6] 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, [7] leading the manufacturer to withdraw these versions from the U.S. market.[ citation needed ] However, in recent years, they have returned to market with both nasal swabs and also dissolving/chewable tablets and nasal spray and oral mist forms, some with zinc, some without.

Ingredients and use

Because this product is a "homeopathic" over-the-counter drug, it is exempt from a number of the requirements ordinarily applicable to OTC drug products, provided it conforms to the standards of the Homeopathic Pharmacopeia of the United States (HPUS) and is labeled as a homeopathic 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". [8]

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. [9] 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. Various non-scientific private studies done by and for the homeopathic industry support its cold-reduction claims: Center of Integrative Medicine [10] and Department of Infections Diseases, Cleveland Clinic Foundation, Cleveland OH. [11] Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca [12] histamine dihydrochloride (homeopathic name histaminum hydrochloricum), [13] luffa operculata, [14] 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 (medically termed anosmia), [7] although the company did not admit fault. [15] As of 2009, "hundreds more such suits have since been filed." [7]

In 2005, the International Brotherhood of Electrical Workers pension fund sued Matrixx Initiatives for misrepresenting the stock by not reporting the risks of Zicam. [16] In Matrixx Initiatives, Inc. v. Siracusano , the U.S. Supreme Court ruled that the union's suit could go forward. [17]

In 2014, Yesenia Melgar commenced an action entitled Melgar v. Zicam LLC, et al. Melgar claimed that Zicam deceived customers by falsely representing that Zicam products "reduce the duration and severity of a cold." The court allowed the case to become a class action suit that included a variety of Zicam products. In 2018, a settlement was reached. Zicam agreed to pay $16,000,000 to people that had purchased Zicam products between Feb. 15, 2011 and June 5, 2018. [18]

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." [19] 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. [19]

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. [20] 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. [20] 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. [21] 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. [22] [23] [24] The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam Cold Remedy. [23]

The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval. [23] The company initially refused to recall the products [25] 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." [26] On June 24, 2009, Matrixx recalled all affected products. [27] 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. [26] 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. [21] [23]

In addition, the FDA's warning letter prompted the Securities and Exchange Commission to investigate the company. [27] 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. [28]

On June 19, 2009, Health Canada, in a foreign product alert, also issued a similar warning based on the U.S. FDA information. [29]

Related Research Articles

<span class="mw-page-title-main">Homeopathy</span> Pseudoscientific system of alternative medicine

Homeopathy or homoeopathy is a pseudoscientific system of alternative medicine. It was conceived in 1796 by the German physician Samuel Hahnemann. Its practitioners, called homeopaths or homeopathic physicians, believe that a substance that causes symptoms of a disease in healthy people can cure similar symptoms in sick people; this doctrine is called similia similibus curentur, or "like cures like". Homeopathic preparations are termed remedies and are made using homeopathic dilution. In this process, the selected substance is repeatedly diluted until the final product is chemically indistinguishable from the diluent. Often not even a single molecule of the original substance can be expected to remain in the product. Between each dilution homeopaths may hit and/or shake the product, claiming this makes the diluent "remember" the original substance after its removal. Practitioners claim that such preparations, upon oral intake, can treat or cure disease.

<span class="mw-page-title-main">Anosmia</span> Inability to smell

Anosmia, also known as smell blindness, is the loss of the ability to detect one or more smells. Anosmia may be temporary or permanent. It differs from hyposmia, which is a decreased sensitivity to some or all smells.

<span class="mw-page-title-main">Common cold</span> Common viral infection of the upper respiratory tract

The common cold or the cold is a viral infectious disease of the upper respiratory tract that primarily affects the respiratory mucosa of the nose, throat, sinuses, and larynx. Signs and symptoms may appear in as little as two days after exposure to the virus. These may include coughing, sore throat, runny nose, sneezing, headache, and fever. People usually recover in seven to ten days, but some symptoms may last up to three weeks. Occasionally, those with other health problems may develop pneumonia.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

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<span class="mw-page-title-main">Xylometazoline</span> Nasal decongestant

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<span class="mw-page-title-main">Cold medicine</span> Medication taken to relieve cold symptoms

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<span class="mw-page-title-main">Benadryl</span> Brand of various antihistamine medications

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Actifed is a registered trademark for a combination antihistamine and nasal decongestant medication used for cold and allergy symptoms. Actifed was developed in 1958 by Burroughs Wellcome & Company, later Haleon.

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<span class="mw-page-title-main">Azelastine</span> Chemical compound

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<span class="mw-page-title-main">Charles B. Hensley</span> American film producer

Charles B. Hensley is an American businessman. In 1997 he invented and developed Zicam, a homeopathic patent medicine for the common cold.

Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27 (2011), is a decision by the Supreme Court of the United States regarding whether a plaintiff can state a claim for securities fraud under §10(b) of the Securities Exchange Act of 1934, as amended, 15 U.S.C. §78j(b), and Securities and Exchange Commission Rule 10b-5, 17 CFR §240.10b-5 (2010), based on a pharmaceutical company's failure to disclose reports of adverse events associated with a product if the reports do not find statistically significant evidence that the adverse effects may be caused by the use of the product. In a 9–0 opinion delivered by Justice Sonia Sotomayor, the Court affirmed the Court of Appeals for the Ninth Circuit's ruling that the respondents, plaintiffs in a securities fraud class action against Matrixx Initiatives, Inc., and three Matrixx executives, had stated a claim under §10(b) and Rule 10b-5.

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References

  1. ↑ Our Story
  2. 1 2 Zicam: Label data, National Institutes of Health
  3. ↑ Salzberg, Steven. "The Top Five Cold Remedies That Do Not Work". Forbes. Retrieved November 21, 2019.
  4. ↑ "Cold-Shortening Products: Are They Worth It?". Reviews.com. February 26, 2019. Retrieved November 21, 2019.[ permanent dead link ]
  5. ↑ "Matrixx Corporate Page". Archived from the original on August 28, 2010. Retrieved April 30, 2009.
  6. ↑ Gorman, Christine (November 15, 1999). "Block That Cold!". Time . Archived from the original on June 22, 2009.
  7. 1 2 3 Harris, Gardinier (June 16, 2009). "FDA Warns Against Use of Zicam". New York Times.
  8. ↑ Bruce W. Jafek; Miriam R. Linschoten; Bruce W. Murrow (May–June 2004). "Anosmia after Intranasal Zinc Gluconate Use". American Journal of Rhinology. 18 (3): 137–141. doi:10.1177/194589240401800302. PMID   15283486. S2CID   12554540.
  9. ↑ "Nasal spray can cause loss of smell, FDA warns". NBC News. Associated Press. June 16, 2009. Archived from the original on February 3, 2013. Retrieved October 16, 2014.
  10. ↑ Hirt, M; Nobel, S; Barron, E (October 2000). "Zinc nasal gel for the treatment of common cold symptoms: a double-blind, placebo-controlled trial". Ear, Nose, & Throat Journal. 79 (10): 778–780, 782. doi: 10.1177/014556130007901008 . PMID   11055098. S2CID   20317285.
  11. ↑ Mossad, S.B. (January 1, 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 August 1, 2014.
  12. ↑ Teut, Michael; Dahler, Jörn; Schnegg, Christoph (2008). "A Homoeopathic Proving of Galphimia glauca". Forschende Komplementärmedizin. 15 (4): 211–217. doi:10.1159/000148825. PMID   18787330. S2CID   39667178.
  13. ↑ Description of Histaminum Hydrochloricum
  14. ↑ Luffa operculata L. COGN Sponge Cucumber Archived December 3, 2013, at the Wayback Machine
  15. ↑ "Homeopathic medicine company fights off Zicam lawsuits". USA Today. August 1, 2007.
  16. ↑ See Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167, 1169 (2009).
  17. ↑ No. 09-1156 (U.S. Mar. 22, 2011) (slip op.).
  18. ↑ "Court Documents | Melgar v. Zicam LLC and Matrixx Initiatives, Inc".
  19. 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.
  20. 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.
  21. 1 2 "Zicam Fact Sheet". U.S. Food and Drug Administration. June 16, 2009. Retrieved June 20, 2009.
  22. ↑ Matrixx Said It Didn’t Give 800 Zicam Reports to FDA (Update1)
  23. 1 2 3 4 Autor, Deborah M. (June 16, 2009). "Warning Letter, FDA Director of Compliance to Matrixx Initiatives, Inc. AKA Zicam LLC". Food and Drug Administration.
  24. ↑ Des Moines Register, June 20, 2009, page 16A.[ full citation needed ]
  25. ↑ F.D.A. Warns Against Use of Popular Cold Remedy, New York Times, June 16, 2009
  26. 1 2 "Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel". Matrixx Corporation. June 16, 2009.
  27. 1 2 "Matrixx recalls Zicam nasal cold products". Associated Press. June 24, 2009. Archived from the original on June 27, 2009.
  28. ↑ Matrixx again asks FDA to rescind Zicam warning, Matrixx Initiatives, in The Arizona Republic , November 19, 2009
  29. ↑ Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size – Foreign Product Alert

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