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Revision as of 16:21, 21 June 2009 by Nagle (talk | contribs) (Quote key sections of actual FDA notice.)(diff) ← Previous revision | Latest revision (diff) | Newer revision → (diff)Zicam is a branded series of cold and allergy remedies whose ingredients include the element zinc. The Zicam name is derived from a combination of the words 'zinc' and 'ICAM-1' (the receptor to which a rhinovirus binds in order to infect cells). Zicam is produced, marketed and sold by Zicam, LLC, a wholly owned subsidiary of Matrixx Initiatives, Inc., an American over-the-counter drug company. In 2009, the U.S. Food and Drug Administration (FDA) advised consumers to avoid intranasal versions of Zicam because of a risk of damage to the sense of smell, leading the manufacturer to withdraw these versions from the U.S. market.
Use and ingredients
The active ingredient in Zicam Cold Remedy is zinc gluconate, which is proposed to interfere with the binding of rhinovirus to its cellular receptor, ICAM-1.. Zicam is marketed as a homeopathic remedy; the homeopathic ingredients include galphimia glauca, histamine dihydrochloride (homeopathic name, histaminum hydrochloricum), luffa operculata, and sulfur.
Some research suggests that zinc-based remedies may reduce the duration of the common cold and reduce the severity of cold symptoms. Another study indicates that zinc-based remedies can relieve symptoms of hay fever and other upper respiratory allergies. A 2003 review in the Journal of the American Pharmacists Association reported that the majority of studies supported the value of zinc in reducing the duration and severity of symptoms of the common cold when administered within 24 hours of the onset of common cold symptoms. A systematic review published in 2006 in Clinical Infectious Diseases found that many of the studies of zinc in the common cold suffered from methodologic flaws; restricting the analysis to well designed studies, the authors concluded that the therapeutic effectiveness of zinc lozenges has yet to be established.
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), although the company did not admit fault. As of 2009, "hundreds more such suits have since been filed."
FDA warning and product withdrawal
A significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products; some individuals also report loss of sense of taste. By comparison, FDA has received few reports of anosmia associated with other widely-used intranasal products for treatment of the common cold that are marketed subject to approved NDAs or according to an OTC drug monograph. Further, there is evidence in the published scientific literature that various salts of zinc can damage olfactory function in animals and humans. ... Your introduction of the Zicam Cold Remedy intranasal products into interstate commerce, without an approved application, violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). ... Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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. The advisory did not implicate other Zicam products. The FDA indicated that it had received reports a loss of smell from approximately 130 Zicam Cold Remedy users since 1999. The FDA voiced concern that the loss of smell may be long-lasting or permanent, while the condition for which Zicam is marketed—the common cold—typically resolves on its own without lasting problems. 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. The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam.
The FDA also issued a warning letter to Matrixx, stating that the products cannot be marketed without FDA approval. The company initially refused to recall the products 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." The company maintained that most cases of anosmia are due to the common cold itself, and that complaints of anosmia among Zicam users are unlikely to be more numerous than those expected among the general population. In contrast, the FDA had reported that cases of anosmia associated with Zicam 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.
References
- Bella J, Rossmann MG., J. Struct Biol. 1999 Dec 1;128(1):69-74, "Rhinoviruses and their ICAM receptors"
- Matrixx Corporate Page
- Gorman, Christine (November 15th, 1999). "Block That Cold!". Time.
{{cite news}}: Check date values in:|date=(help) - ^ Harris, Gardinier (June 16, 2009). "FDA Warns Against Use of Zicam". New York Times.
- PMID 15496046
- A Homoeopathic Proving of Galphimia glauca
- Description of Histaminum Hydrochloricum
- Luffa operculata L. COGN Sponge Cucumber
- Mossad SB (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. PMID 12509647.
{{cite journal}}: Unknown parameter|month=ignored (help) - Sid Kirchheimer, WebMD Health News, Jan. 7, 2003, "Zinc Spray Shortens Colds"
- S. Nobel : "Daily Application Of The Homeopathic Remedy Zicam Allergy Relief Significantly Improves The Quality Of Life And Impairment In Patients With Seasonal Allergic Rhinitis", The Internet Journal of Family Practice, 2000, Volume 1 Number 1
- Hulisz D (2004). "Efficacy of zinc against common cold viruses: an overview". J Am Pharm Assoc (2003). 44 (5): 594–603. doi:10.1331/1544-3191.44.5.594.Hulisz. PMID 15496046.
- Caruso TJ, Prober CG, Gwaltney JM (2007). "Treatment of naturally acquired common colds with zinc: a structured review". Clin. Infect. Dis. 45 (5): 569–74. doi:10.1086/520031. PMID 17682990.
{{cite journal}}: Unknown parameter|month=ignored (help)CS1 maint: multiple names: authors list (link) - http://www.usatoday.com/money/industries/health/2007-08-01-zicam_N.htm
- ^ Autor, Deborah M. (June 16, 2009). "Warning Letter, FDA Director of Compliance to Matrixx Initiatives, Inc. AKA Zicam LLC".
- ^ "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.
- ^ "Zicam Fact Sheet". U.S. Food and Drug Administration. June 16, 2009. Retrieved June 20, 2009.
- http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aDC21YXDGWvY
- Des Moines Register, June 20, 2009, page 16A.
- F.D.A. Warns Against Use of Popular Cold Remedy, New York Times, June 16, 2009
- ^ "MATRIXX INITIATIVES VOLUNTARILY WITHDRAWS ZICAM COLD REMEDY SWABS, ZICAM COLD REMEDY NASAL GEL". Matrixx Corporation. June 16, 2009.