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| ==Use and ingredients== | ==Use and ingredients== | ||
| The active ingredient in Zicam Cold Remedy is ], which is proposed to interfere with the binding of ] to its cellular receptor, ].<ref>PMID 15496046</ref><!--someone please expand--> Zicam is marketed as a ] remedy; the homeopathic ingredients include galphimia glauca,<ref>A Homoeopathic Proving of Galphimia glauca </ref> histamine dihydrochloride (homeopathic name, histaminum hydrochloricum),<ref>Description of Histaminum Hydrochloricum </ref> ],<ref>Luffa operculata L. COGN Sponge Cucumber </ref> and ]. | The active ingredient in Zicam Cold Remedy is ], which is proposed to interfere with the binding of ] to its cellular receptor, ].<ref>PMID 15496046</ref><!--someone please expand-->. Zicam is marketed as a ] remedy; the homeopathic ingredients include galphimia glauca,<ref>A Homoeopathic Proving of Galphimia glauca </ref> histamine dihydrochloride (homeopathic name, histaminum hydrochloricum),<ref>Description of Histaminum Hydrochloricum </ref> ],<ref>Luffa operculata L. COGN Sponge Cucumber </ref> and ]. | ||
| Some research suggests that zinc-based remedies may reduce the duration of the ] and reduce the severity of cold symptoms.<ref>{{cite journal |author=Mossad SB |title=Effect of zincum gluconicum nasal gel on the duration and symptom severity of the common cold in otherwise healthy adults |journal=QJM |volume=96 |issue=1 |pages=35–43 |year=2003 |month=January |pmid=12509647 |doi= |url=}}</ref><ref>Sid Kirchheimer, WebMD Health News, Jan. 7, 2003, "Zinc Spray Shortens Colds"</ref> Another study indicates that zinc-based remedies can relieve symptoms of ] and other upper respiratory ].<ref>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 </ref> 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.<ref name="pmid15496046">{{cite journal |author=Hulisz D |title=Efficacy of zinc against common cold viruses: an overview |journal=] |volume=44 |issue=5 |pages=594–603 |year=2004 |pmid=15496046 |doi= 10.1331/1544-3191.44.5.594.Hulisz|url=http://japha.metapress.com/openurl.asp?genre=article&issn=1544-3191&volume=44&issue=5&spage=594}}</ref> A ] published in 2006 in '']'' found that many of the studies of zinc |
Some research suggests that zinc-based remedies may reduce the duration of the ] and reduce the severity of cold symptoms.<ref>{{cite journal |author=Mossad SB |title=Effect of zincum gluconicum nasal gel on the duration and symptom severity of the common cold in otherwise healthy adults |journal=QJM |volume=96 |issue=1 |pages=35–43 |year=2003 |month=January |pmid=12509647 |doi= |url=}}</ref><ref>Sid Kirchheimer, WebMD Health News, Jan. 7, 2003, "Zinc Spray Shortens Colds"</ref> Another study indicates that zinc-based remedies can relieve symptoms of ] and other upper respiratory ].<ref>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 </ref> 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.<ref name="pmid15496046">{{cite journal |author=Hulisz D |title=Efficacy of zinc against common cold viruses: an overview |journal=] |volume=44 |issue=5 |pages=594–603 |year=2004 |pmid=15496046 |doi= 10.1331/1544-3191.44.5.594.Hulisz|url=http://japha.metapress.com/openurl.asp?genre=article&issn=1544-3191&volume=44&issue=5&spage=594}}</ref> A ] published in 2006 in '']'' 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.<ref>{{cite journal |author=Caruso TJ, Prober CG, Gwaltney JM |title=Treatment of naturally acquired common colds with zinc: a structured review |journal=Clin. Infect. Dis. |volume=45 |issue=5 |pages=569–74 |year=2007 |month=September |pmid=17682990 |doi=10.1086/520031 |url=}}</ref> | ||
| ⚫ | ==Litigation== | ||
| ==Anosmia allegations== | |||
| ⚫ | In 2006, Matrixx Initiatives paid $12 million to settle 340 lawsuits from Zicam users who said that the product destroyed their sense of smell<ref name="NYT1"/> (medically termed ]), although the company did not admit fault.<ref>http://www.usatoday.com/money/industries/health/2007-08-01-zicam_N.htm</ref> As of 2009, "hundreds more such suits have since been filed."".<ref name="NYT1">{{cite news | | ||
| ⚫ | |||
| ⚫ | In 2006, Matrixx Initiatives paid $12 million to settle 340 lawsuits from Zicam users who said that the product destroyed their sense of smell<ref name="NYT1"/> (medically termed ]), although the company did not admit fault.<ref>http://www.usatoday.com/money/industries/health/2007-08-01-zicam_N.htm</ref> As of 2009, "hundreds more such suits have since been filed."<ref name="NYT1">{{cite news | | ||
| url=http://www.nytimes.com/2009/06/17/health/policy/17nasal.html?hp | | url=http://www.nytimes.com/2009/06/17/health/policy/17nasal.html?hp | | ||
| title=FDA Warns Against Use of Zicam | | title=FDA Warns Against Use of Zicam | | ||
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| date=June 16, 2009 }}</ref> | date=June 16, 2009 }}</ref> | ||
| == FDA warning and product withdrawal == | |||
| On June 16, 2009, the ] (FDA) advised consumers to discontinue use of nasally administered versions of Zicam because of a "serious risk" of anosmia associated with the product. According to the FDA approximately 130 Zicam users reported a loss of smell since 1999.<ref> | On June 16, 2009, the ] (FDA) advised consumers to discontinue use of nasally administered versions of Zicam because of a "serious risk" of ] associated with the product. According to the FDA approximately 130 Zicam users reported a loss of smell since 1999.<ref> | ||
| {{cite web | {{cite web | ||
| | url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm | | url = http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm | ||
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| publisher=Matrixx Corporation | | publisher=Matrixx Corporation | | ||
| title=MATRIXX INITIATIVES VOLUNTARILY WITHDRAWS ZICAM COLD REMEDY SWABS, ZICAM COLD REMEDY NASAL GEL | | title=MATRIXX INITIATIVES VOLUNTARILY WITHDRAWS ZICAM COLD REMEDY SWABS, ZICAM COLD REMEDY NASAL GEL | | ||
| date=June 16, 2009 }}</ref> The company maintained that |
date=June 16, 2009 }}</ref> The company has maintained their view that the cases of anosmia were due to the common cold rather than Zicam.<ref name="PR1"/> | ||
| ==References== | ==References== | ||
Revision as of 18:19, 20 June 2009
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 issued a warning to consumers to avoid Zicam because of a risk of damage to the sense of smell, leading the manufacturer to withdraw Zicam 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.
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
On June 16, 2009, the Food and Drug Administration (FDA) advised consumers to discontinue use of nasally administered versions of Zicam because of a "serious risk" of anosmia associated with the product. According to the FDA approximately 130 Zicam users reported a loss of smell since 1999. The FDA also issued a warning letter to Matrixx, stating that the products cannot be marketed without FDA approval. In response, the company said the products would be withdrawn from sale, stating that, "based on the FDA’s recommendation, consumers should discard any unused product or contact Zicam ... to request a refund." The company has maintained their view that the cases of anosmia were due to the common cold rather than Zicam.
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
- "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.
- Autor, Deborah M. (June 16, 2009). "Warning Letter, FDA Director of Compliance to Matrixx Initiatives, Inc. AKA Zicam LLC".
- ^ "MATRIXX INITIATIVES VOLUNTARILY WITHDRAWS ZICAM COLD REMEDY SWABS, ZICAM COLD REMEDY NASAL GEL". Matrixx Corporation. June 16, 2009.