Re: 2/2/04 - [MTXX] PR: Matrixx Initiatives Reaffirms Safety of Intranasal Zicam(R) Cold Remedy; The Denver Channel: User Says Zicam Robbed Her Of Sense Of Smell - FDA Investigating Zicam Gel, Which Is Applied Directly In Nose; PR: Matrixx Initiatives Reaffirms Safety of Intranasal Zicam Cold Remedy; Dow Jones: Matrixx Shares Slump on Reports Raising Concerns on Zicam
Press Release Source: Matrixx Initiatives, Inc.
Matrixx Initiatives Reaffirms Safety of Intranasal Zicam(R) Cold Remedy
Monday February 2, 3:16 pm ET
Matrixx Initiatives, Inc., the manufacturer of Zicam(R) Cold Remedy, responds to the Dow Jones 'In The Money report: FDA Looks Into Complaints About Zicam,' by Carol S. Remond, alleging that the FDA is investigating consumer complaints regarding intranasal zinc gluconate-induced loss of smell.
PHOENIX, Feb. 2 /PRNewswire-FirstCall/ -- Matrixx Initiatives, Inc., the manufacturer of Zicam® Cold Remedy, is not aware of an FDA inquiry into the safety of our intranasal zinc-gluconate products, as alleged by Carol S. Remond's column Dow Jones "In The Money report: FDA Looks Into Complaints About Zicam."
All Zicam products are manufactured and marketed according to FDA guidelines for homeopathic medicine. Our primary concern is the health and safety of our customers and the distribution of factual information about our products. Matrixx believes statements alleging that intranasal Zicam products cause anosmia (loss of smell) are completely unfounded and misleading.
In no clinical trial of intranasal zinc gluconate gel products has there been a single report of lost or diminished olfactory function (sense of smell). Rather, the safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebo-controlled, randomized clinical trials. In fact, in neither study were there any reports of anosmia related to the use of this compound. The overall incidence of adverse events associated with zinc gluconate was extremely low, with no statistically significant difference between the adverse event rates for the treated and placebo subsets.
A multitude of environmental and biologic influences are known to affect the sense of smell. Chief among them is the common cold. As a result, the population most likely to use cold remedy products is already at increased risk of developing anosmia. Other common causes of olfactory dysfunction include age, nasal and sinus infections, head trauma, anatomical obstructions, and environmental irritants.
The circumstances surrounding the development of Ms. Remond's column are extremely suspect. The article appeared online in public financial message boards almost immediately following its availability through the Dow Jones "In The Money" subscription-only service. At least one of these message board postings was made by a registered username frequently used by Floyd Schneider, a defendant currently being sued for defamation by Matrixx Initiatives. From at least August 2001 to the present, Schneider has posted false and defamatory statements about Matrixx on various Internet message boards using a variety of anonymous aliases. It has come to our attention that Schneider has also attempted to interfere with Matrixx' business by contacting our retail customers.
Ms. Remond's article appears on today's Dow Jones Newswire -- the very day that Matrixx Initiatives is deposing Schneider. We believe that the timing of this article was manipulated by Schneider to interrupt the deposition process. We know that Ms. Remond and Schneider were in close communication during the development of Ms. Remond's article and even discussed the disclosure statement detailing the basis for our suit against Schneider, which has not yet been made public. Therefore, it is particularly troubling that Ms. Remond neglected to mention the defamation action or that Schneider was one of her chief sources of information. We consider her failure to mention these facts to be a significant omission in fair and balanced reporting.
Matrixx Initiatives would like to underscore that we intend to vigorously pursue those individuals involved in any effort to improperly discredit the company and its products. Furthermore, we strongly urge Dow Jones to open its own investigation to determine whether Dow Jones' credibility was undermined by the use of copyrighted material in an attempt to do further harm to the value and reputation of Matrixx Initiatives and its products.
--------------------------------------------------------------------------------
Source: Matrixx Initiatives, Inc.
biz.yahoo.com
=====
User Says Zicam Robbed Her Of Sense Of Smell
FDA Investigating Zicam Gel, Which Is Applied Directly In Nose
POSTED: 2:02 PM MST February 5, 2004
UPDATED: 2:30 PM MST February 6, 2004
A nationally advertised cold product that may now be in your family medicine cabinet could rob you or your children of the ability to smell -- to smell gas or a fire in your home or to enjoy the aroma and taste of your food, 7NEWS Investigator John Ferrugia said.
7NEWS began investigating Zicam a month ago after one of our own employees said she had lost her sense of smell after using it. Now the Food and Drug Administration has begun its own investigation of complaints around the country.
Linda Bayley is finally coming to the realization that she has lost her sense of smell. According to the doctors at the University of Colorado Center for Taste and Smell Disorders, it's not likely she will get it back.
"You just do not have enough receptor cells to know what you are smelling," Dr. Miriam Linschoten told Bayley.
"You know, looking at your whole life and not being able to smell and not being able to have flavors, all because you used a product. I mean, it's just not fair, it's just not fair," Bayley said, sobbing.
Bayley and other consumers around the country claim that that product is Zicam gel, which contains zinc gluconate and is applied in the nose.
Bayley is one of more than a dozen patients Dr. Bruce Jafek has either examined personally or referred to others when they reported the loss of smell after using Zicam Intranasal Zinc.
He is now preparing to publish his findings.
"At least in the majority of the patients we have seen, there hasn't been a return of function," Jafek said.
Jafek says Bayley's experience with Zicam mirrors the stories of others who have used the Zicam compound and lost their sense of smell.
"I put it up my nose, like you are supposed to ... you don't inhale it, and you are supposed to hold your nostril closed ... and the burning," Bayley said. "I had the most intense burning sensation that was just ... I mean, it threw me for a loop, it was so bad. "
The next day, as she picked up her cat, she realized she had a serious problem.
"I was cleaning her cat box and I realized I couldn't smell. I couldn't smell the cat box," Bayley said.
And then she couldn't smell her favorite food -- pumpkin pie.
"When I ate a piece I couldn't taste it. It was just bland mush," Bayley said.
Jafek says the problems of zinc compounds used in the nose are well-known -- they began in the 1930s when people were trying to prevent polio.
"It did not work for polio but was found that about 10 percent of the people lost their sense of smell as a result of the zinc application ... permanently," Jafek said. "Closer to the present day, then it has been used in animal experiments, particularly in fish and rodents, mice and rats, in which the purpose was to put zinc into the nose and destroy the sense of smell."
But in those cases, a compound of zinc sulfate is used. Zicam contains zinc gluconate. The manufacturer, Matrixx Initiatives, says there is a significant difference in the compounds.
"Not in my mind. The idea in terms of the zinc treatment of a cold is that you want to get the zinc ion into the nose where it will have anti-viral activity," Jafek said.
Matrixx declined an on-camera interview but told 7NEWS in an e-mail: "Statements alleging that intranasal Zicam products cause anosmia (loss of smell) are completely unfounded and misleading."
The company says, "The safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebo-controlled, randomized clinical trials."
It also noted, "a multitude of environmental and biologic influences are known to affect the sense of smell."
Both Jafek and Linschoten examined the company's studies and say they simply do not address the safety question.
"Since they didn't test for smell loss before and after, no (these studies) are not relevant," Linschoten said.
"There's no doubt in my mind there's a cause and effect just because I took it, it burned like crazy, the next day I didn't have any sense of smell," Bayley said.
For Bayley, the thought has brought anger, frustration, and an emotional sense of loss.
"You know, the people who are closest to you, your family, it's not something you think about, but being able to smell them -- my little infant, my baby cousin. I can't smell babies anymore," Bayley said. "That human closeness. It's a connection. It's a connection lost."
Zicam makes several products. Only one is in question: the nasal gel or swabs for your nose, which contain zinc gluconate and is listed on the packaging. This does not apply to lozenges or other Zicam products.
In addition to the FDA investigation of complaints, there have now been four separate lawsuits filed against the maker of Zicam. The company has denied liability.
Another nationally known company makes a zinc spray one that people may use. There are reports of similar loss of smell with this product as well.
7NEWS will have more on this story Friday at 10:15 p.m.
-----
Video
Hear How One User Says Zicam Destroyed Her Smell: thedenverchannel.com
Discuss Zicam With Others: forums.ibsys.com
Contact The Investigators: mailto:7newsinvestigates@thedenverchannel.com
Additional Resources
Contact The Investigators About This Story: mailto:7newsinvestigates@thedenverchannel.com
Discuss Zicam With Others: forums.ibsys.com
Zicam's Web site: zicam.com
Rocky Mountain Taste and Smell Center at the University of Colorado Medical Center: uchsc.edu
Copyright 2004 by TheDenverChannel.com. All rights reserved.
thedenverchannel.com
-----
See also the Good Morning America site:
abcnews.go.com
=====
Press Release Source: Matrixx Initiatives, Inc.
Matrixx Initiatives Reaffirms Safety of Intranasal Zicam Cold Remedy
Friday February 6, 3:59 pm ET
PHOENIX--(BUSINESS WIRE)--Feb. 6, 2004--Matrixx Initiatives, Inc., (NASDAQ: MTXX - News) the manufacturer of Zicam® Cold Remedy zinc products, said today that reports alleging anosmia--or loss of smell--in a small number of patients using zinc gluconate intranasal gels for the treatment of the common cold are completely unfounded and misleading. At this time, the company is not aware of any investigation by a regulatory body with regard to the product.
We want to assure our consumers that Zicam Cold Remedy intranasal zinc gluconate products are manufactured and marketed according to Food and Drug Administration guidelines for homeopathic medicine. Our primary concerns are the health and safety of those who use Zicam Cold Remedy nasal gels and the distribution of factual information about our products.
In no clinical trial of intranasal zinc gluconate gel products has there been a single report of lost or diminished olfactory function (sense of smell). Rather, the safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebo-controlled, randomized clinical trials. In fact, in neither study were there any reports of anosmia related to the use of this compound. The overall incidence of adverse events associated with zinc gluconate was extremely low, with no statistically significant difference between the adverse event rates for the treated and placebo subsets.
A multitude of environmental and biologic influences are known to affect the sense of smell. Chief among them is the common cold. As a result, the population most likely to use cold remedy products is already at increased risk of developing anosmia. Other common causes of olfactory dysfunction include age, nasal and sinus infections, head trauma, anatomical obstructions, and environmental irritants.
Zinc and Loss of Smell Research
A few researchers have attempted to link nasal products containing zinc to the onset of anosmia. However, this hypothesis is based on data from polio studies conducted in the 1930s using a concentrated zinc sulfate solution. Current nasal products, such as Zicam Cold Remedy, contain zinc gluconate, which is an entirely different compound.
Zinc sulfate is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide, which is practically insoluble in water. By comparison, zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate--a naturally occurring, non-toxic compound found in all human tissues. Zicam Cold Remedy is a buffered gel, formulated to have a neutral pH--i.e., a pH that approximates that of the nasal cavity.
About Matrixx Initiatives, Inc.
Matrixx Initiatives, Inc. is engaged in the development, manufacture and marketing of over-the-counter (OTC) pharmaceuticals which utilize innovative drug delivery systems. Zicam, LLC, its wholly-owned subsidiary, produces, markets and sells Zicam® Cold Remedy nasal gel, a patented, homeopathic remedy that has been clinically proven to reduce the duration and severity of the common cold. In studies published in the October 2000 issue of ENT -- Ear, Nose and Throat Journal, and separately in the January 2003 issue of QJM: An International Journal of Medicine, the Zicam Cold Remedy nasal gel product was shown to reduce the duration of the common cold. The Company also manufactures and markets a full line of Zicam brand pharmaceuticals, including Zicam Cold Remedy Swabs; Zicam Kids Size Cold Remedy Swabs; Zicam Cold Remedy Oral Mist, Zicam Cold Remedy Chewables, Zicam Cold Remedy RapidMelts, Zicam Allergy Relief, Zicam Extreme Congestion Relief; Zicam Sinus Relief; and Zicam Nasal Moisturizer. For more information regarding Matrixx products, go to www.zicam.com . To find out more about Matrixx Initiatives, Inc. (Nasdaq: MTXX - News), visit our website at www.matrixxinc.com. For additional information, contact William Hemelt, executive vice president and chief financial officer, 602-387-5353, whemelt@matrixxinc.com, or Lynn Romero, investor relations, at 602-387-5353, lromero@matrixxinc.com. Matrixx is located at 2375 East Camelback Road, Suite 500, Phoenix, Arizona 85016.
--------------------------------------------------------------------------------
Contact:
Matrixx Initiatives, Inc., Phoenix
William Hemelt, 602-387-5353
whemelt@matrixxinc.com
or
Investor Relations:
Lynn Romero, 602-387-5353
lromero@matrixxinc.com
--------------------------------------------------------------------------------
Source: Matrixx Initiatives, Inc.
biz.yahoo.com
=====
Dow Jones Business News
Matrixx Shares Slump on Reports Raising Concerns on Zicam
Friday February 6, 5:19 pm ET
By Amy Braunschweiger
NEW YORK -- Shares of Matrixx Initiatives Inc. (NasdaqNM:MTXX - News) plummeted after ABC News' 'Good Morning America' aired a segment featuring a woman who claims she lost her sense of smell using Matrixx's nasal-spray cold remedy, Zicam, which contains zinc.
The show, which boasts five million daily viewers, aired the piece about Zicam between 8 a.m. and 8:30 a.m. EST, said spokesperson Bridgette Maney. ABC is owned by Walt Disney Co. (NYSE:DIS - News) .
Dow Jones Newswires reported a week ago that the Food and Drug Administration (News - Websites) was looking into complaints the use of the nasal spray may be leading some consumers to lose their sense of smell. The story noted some studies have found a high concentration of zinc, injected into the nose, may cause anosmia, or a lost sense of smell. At least three lawsuits have been filed by individuals who used the cold remedy against Matrixx and Zicam LLC, its wholly-owned subsidiary.
Matrixx issued a statement Monday claiming it was unaware of an FDA inquiry into the safety of its product.
During Matrixx's three clinical trials for Zicam Cold Remedy, none of the patients reported a loss of smell, Tim Clarot, vice president of research and development, said Friday. "Any adverse event is all documented," he added, noting side effects varied little between the placebo and the active drug.
Mr. Clarot said the first trial involved about 200 people, while the next two trials both involved about 85 people. "We are confident that this is a safe" product, he added.
He went on to say Matrixx's nasal spray contained a buffer solution and a " very low level of zinc." Mr. Clarot said studies that claim a connection between zinc and loss of smell were performed on animals using a zinc sulfate that is a "very concentrated solution."
At 4 p.m. EST on the Nasdaq Stock Market (News - Websites) , shares of Matrixx were down $3.11, or 24%, at $9.94 on volume of four million shares. The daily average is 196,926. The stock earlier got as low as $9.25.
The 'Good Morning America' piece on Zicam also spoke with Dr. Bruce Jafek, of the Department of Otolaryngology at the University of Colorado School of Medicine, who claims he knows of more patients who lost their sense of smell after using Zicam. The segment, which lasted roughly four minutes, went on to list studies that noted a relationship between zinc and anosmia.
A similar piece aired Thursday on ABC' Denver affiliate, KMGH. The journalist who reported the piece airing in Denver also wrapped the piece up for 'Good Morning America.'
Zicam Cold Remedy, one of 10 Zicam products, accounted for about 60% of Matrixx's revenue last year.
-By Amy Braunschweiger; Dow Jones Newswires; 201-938-2205; amy.braunschweiger@dowjones.com
biz.yahoo.com |
