liveonearth (liveonearth) wrote,
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ZICAM Alert: the cold med, the FDA, and homeopathic meds

Over the last few years I have suggested this product to quite a few people, because it works. Now I find out that the FDA has pulled it from the market because it can kill your sense of smell. Zicam is intranasal zinc administered with a swab or squirt. You absorb the zinc through your mucosal membrane, and it helps you fight viruses. Absorption of zinc through the gastrointestinal system is not very good. Having a steady stream of zinc in your bloodstream is supposedly beneficial when fighting a cold or flu bug. I don't have references for all this, but I can tell you that I have never had another cold since discovering the stuff, and I can still smell.

Zicam is actually a 10% solution of zinc gluconate. I don't dispute that zinc can damage the olfactory receptors that give us a sense of smell. The research references are included at the bottom of this post. What I notice is that if you follow the instructions on the bottle literally, the gel will not get to your olfactory nerve endings. I'm not reading a bottle here, I'm only telling you my understanding of the instructions. You're not supposed to snort it up your nose, or to inhale a spray. You're supposed to blow your nose, then coat your outermost nasal mucosa and keep the gel there as long as you can stand it (without snorting it up in your head) and then blow your nose again. There was a study on mice that showed anosmia only in the ones who received very large doses, and I suspect this may be true of humans. Ie, you can hurt yourself with it. You can hurt yourself with almost anything.

Apparently nasal zinc products have been banned from the market before, for the same reason. They can cause anosmia. Zicam apparently found a loophole in the law to avoid oversight, by claiming to be a homeopathic remedy. Homeopathic medicines are supposedly too dilute to do any harm by direct physical action. They are supposed to work energetically. So Zicam was not chemically evaluated until it had been on the market for years.

I personally didn't ever think it was a homeopathic, because it worked. I'm a skeptic of homeopathy, and when zicam worked, I looked carefully at the label and decided that they must have called it homeopathic for marketing reasons. Because the amount of zinc is right there on the label. And I know that many people are zinc deficient, and that zinc is involved somehow in the metabolism involved in fighting viruses. The part that is news to me is that intranasal zinc causes anosmia in up to 10% of users. That's a big risk if its true.

I remember noticing that Zicam was selling well. The grocery stores couldn't keep it in. The NYT article says the product has "no proven benenfit" but I'm a believer in the market; if a product flies off the shelves, it's doing somebody some good. Zicam quickly appeared in all large retail chains including grocery stores, drug stores and big box stores. An expanded product line gave several options for how to get the stuff up your nose. They must have made gajillions on the stuff before the FDA noticed. Ah, here's an indication of their take, from the New York Times: "Matrixx had $101 million in sales last year, of which $40 million came from Zicam products." According to the NYT article Matrixx refused to recall its products, though it has suspended shipments and is offering reimbursement to customers who want a refund. The FDA sent Matrixx a "warning letter" which is supposed to result in a recall, but the business is breaking the unwritten rules. Matrixx disputes that its product causes anoxmia, and dares the FDA to prove it. Their statement says the FDA action is "unwarranted" and that they are going to seek meetings to review the product safety data. Mmmmmm Hmmmmm. And make a new deal.

If Matrixx can "refuse" to recall its products, what is the FDA good for anyway?

Zicam was successful because it met a nutritional need and really stopped people from getting sick from viruses. It occurs to me that many times in the past supposed homeopathic medicines may have helped sick people because they contained some mineral that was lacking in that person. I think also that some nosodes--remedies which contain diseased material--act like vaccines. So there are at least these two ways in which homeopathic medicine could have "worked" without it having anything to do with the spirit of the material that is no longer present because it has been diluted so many times.

Where I stand is complicated, a work in progress, it always is. I think the product should stay on the shelf, with a warning on the label. There are dire risks with nearly any medication, but we get all excited about one or another without addressing the picture as a whole. Why not ban tylenol because it is the #1 cause of fatal liver failure? I think that all "medicines" should be evaluated chemically and medically by someone other than the manufacturers. If the FDA were not so corrupt, I would feel fine about them testing our food and drugs. But the FDA continues to demonstrate that it is working "with the industry" instead of for the people. I don't trust them, and their decrees have little bearing on what I think is safe or reasonable for a person to take in.



BELOW HERE THREE POSTS FROM DENVER NATUROPATHIC ON THE SUBJECT OF ZICAM, MOST RECENT FIRST
(PLS do not assume that I agree with everything he says, but I thank him nonetheless.)

Zicam Warning: It is about Time
June 16, 2009
Jacob Schor, ND, FABNO

This evenings news reports tell us the FDA has finally issued a warning about Zicam, the supposedly homeopathic medicine for colds.

From the National Public Radio report:

“FDA: Zicam Nasal Spray Can Cause Loss Of Smell

AP, June 16, 2009 · Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Zicam products since 1999.”

Read the full story at:
http://www.npr.org/templates/story/story.php?storyId=105483442

Our regular readers have grown accustomed to me stomping on my little soapbox about this business for many years.

Links to our recent Zicam Warnings:

February 2006 http://denvernaturopathic.com/news/ziccam.html
November 2008 http://denvernaturopathic.com/zicam2008.htm

All I can wonder is why it took the FDA so long to act.




THE FEB 06 POST
Zicam Caution
February 15, 2006
Jacob Schor, ND

Subject: Zicam, the over the counter remedy for cold symptoms, can cause loss of taste.

Over the last few months a number of people have asked my opinion of Zicam,
especially after I wrote about my favorite treatments for colds and flu. I have
always been a little hesitant to recommend Zicam simply because their label is
so misleading. Zicam claims to be a homeopathic preparation. Technically it may
be homeopathic but it is a real stretch to see it so and that has always made me
suspicious of the other claims made by the manufacturer. Recent revelations and
law suits cast more suspicion on the product.

Zicam claims to be homeopathic Zincum gluconicum in 1 x potency. What this
means in English is that it is a 10% solution of zinc gluconate. Typically
homeopathic remedies are sold in much more dilute solutions. For example a 6 x
potency is one part in a million of the original substance. A 12 x potency is
one part in a billion. A 30 x potency is so dilute that there isn’t even a
molecule of the original substance left. This is why homeopathic medicines are
considered safe; there is little or nothing left to cause harm. In the case of
Zicam, by calling it homeopathic and adopting the homeopathic terminology, the
manufacturer found a way to market a 10% solution of zinc gluconate without FDA
oversight.

In other words Zicam is just an intranasal zinc solution. Intranasal zinc has
been known to destroy the ability to smell in both animals and people. In the
1930s, zinc compounds were used in attempts to prevent polio. About 10% of the
people who received the zinc compounds lost their sense of smell permanently.
For years there had been no attempt to use intranasal zinc in humans. However
because Zincam products fall under the homeopathic provision of FDA laws, these
products are not required to get FDA approval before they were put on the
market.

By the way loss of smell is called anosmia.

It is not even clear that these products are useful for treating colds. While
two placebo-controlled trials found that intranasal zinc gluconate modestly
shortened the duration of cold symptoms two other placebo-controlled studies
found intranasal zinc to be of no benefit.

In the most rigorously controlled of these studies, intranasal zinc gluconate
did not affect the severity or duration of cold symptoms in volunteers
inoculated with rhinovirus, a common cause of colds. These studies did find
evidence of anosmia and warned about the condition. The reports stated that
since zinc-associated anosmia may be irreversible.

Earlier this month the manufacturers of Zicam agreed to pay $12 million dollars
to settle a class action law suit brought by 340 consumers who had lost their
ability to smell after using Zicam products. The company which made $46 million
dollars in the first 9 months of 2005 does not plan to take their products off
the market. Even with settling the lawsuits the products are still very
profitable.

Some people have told me they find Zicam an effective aid in treating their
symptoms. Yet if we heed Hippocrates’ injunction to, First, Do no harm, we must
consider Zicam an unacceptable risk and suggest not using it..



Annual Zicam Warning

November 15, 2008

The Zicam emails have started again.

Several years ago I posted a newsletter on our website warning of the danger of using the over the counter product called Zicam to treat colds. The product’s active ingredient is zinc. It has long been known that topical zinc applied to the nasal membranes will occasionally cause loss of smell, a condition called anosmia.

One would think that the Food and Drug Administration (FDA) would yank this product off the market but the makers have slipped the product through an oversight loophole by calling it ‘homeopathic.’

People seem to find my posted warnings, after the fact, when they have suddenly lost all perception of smell. They write hoping that I will have a cure for their condition.

So far the medical journals have revealed no magic solution, just that these zinc products are clearly to blame in a number of cases. A May 2004 paper written by three local doctors explains that this condition is often permanent. A 2006 paper describes 17 patients with zinc induced anosmia seen in San Diego.

It’s not even clear that zinc helps the common cold. A 2007 literature review from Stanford University tried to figure this out. At the time there were 105 published reports of studies attempting to test zinc’s effect. Only fourteen were randomized, placebo-controlled studies that examined the effect of zinc lozenges, nasal sprays, or nasal gels on naturally acquired common colds. Of those 14 studies, when carefully evaluated for stringent design criteria, only four of the 14 studies were judged reliable. Three of these studies reported no therapeutic effect from zinc lozenge or nasal spray. One study reported positive results from zinc nasal gel. That’s not very convincing, given the risks.

Another paper from 2007 suggests that zinc might not be the culprit after all. Florida researcher blasted mice with zinc nasal sprays and only found loss of smell in the mice that got the heavy doses. Moderate doses didn’t seem to cause a problem. Of course mice and people are not the same.

There’s a Korean paper published last summer that reports that combining dexamthasone (steroids) and ginkgo appears to improve anosmia. Well it does in mice who were poisoned. Whether this works in people with zinc damage is yet to be seen.

References:

Am J Rhinol. 2004 May-Jun;18(3):137-41.

Anosmia after intranasal zinc gluconate use.

Jafek BW, Linschoten MR, Murrow BW.

Departmtent of Otolaryngology-Head and Neck Surgery, University of Colorado School of Medicine, Denver, Colorado 80262, USA.

BACKGROUND: Zinc is an essential mineral. Beneficial zinc absorption takes place via enteral, parenteral, or cutaneous routes. However, direct application to the olfactory epithelium has been reported to cause loss of smell. Recently, intranasal zinc gluconate has been recommended as a treatment for the common cold. Severe posttreatment hyposmia and anosmia have been observed. METHODS: The case report of a typical patient is presented and analyzed in detail, followed by a series of patients with severe hyposmia or anosmia after the use of intranasal zinc gluconate. RESULTS: Although interindividual variation in drug response and drug effect is apparent, the severe hyposmia or anosmia appears to be long lasting or permanent in some cases. The mechanism of olfactory loss is thought to be the direct action of the divalent zinc ion on the olfactory receptor cell. CONCLUSIONS: Zinc ions are toxic to olfactory epithelium. Reports of severe hyposmia with parosmia or anosmia have occurred after intranasal use of zinc gluconate.



Laryngoscope. 2006 Feb;116(2):217-20.

Intranasal zinc and anosmia: the zinc-induced anosmia syndrome.

Alexander TH, Davidson TM.

Department of Surgery, Head and Neck Surgery and Continuing Medical Education, University of California, San Diego School of Medicine, VA San Diego Healthcare System, San Diego, CA 92103, USA.

OBJECTIVE: Commercial preparations of intranasal zinc gluconate gel are marketed as a remedy for the common cold. However, intranasal zinc has been reported as a cause of anosmia in humans and animals. Seventeen patients presenting with anosmia after the use of intranasal zinc gluconate are described. METHODS: The authors conducted a retrospective case series of patients presenting to a nasal dysfunction clinic and conducted complete history and physical examination on all patients, including nasal endoscopy. All patients underwent detailed odor threshold and identification testing. RESULTS: Threshold and identification testing revealed impaired olfaction in all patients. Inflammatory and traumatic causes of anosmia were excluded based on history, physical examination, and imaging. All patients diagnosed with zinc-induced anosmia or hyposmia reported sniffing deeply when applying the gel. This was followed by an immediate sensation of burning lasting minutes to hours. Loss of sense of smell was then perceived within 48 hours. Seven of 17 patients never developed symptoms of an upper respiratory infection. CONCLUSIONS: The zinc-induced anosmia syndrome, characterized by squirt, sniff, burn, and anosmia, occurs after the exposure of olfactory epithelium to zinc cation. It can be distinguished from postviral anosmia based on history.

Clin Infect Dis. 2007 Sep 1;45(5):569-74. Comment in:

Clin Infect Dis. 2008 Feb 1;46(3):483-4.

Treatment of naturally acquired common colds with zinc: a structured review.

Caruso TJ, Prober CG, Gwaltney JM Jr.

1Stanford University School of Medicine, Stanford, California, USA.

BACKGROUND: Over the past 20 years, the use of zinc as an over-the-counter alternative therapy for the common cold has vastly grown in popularity. Recent reports of potentially permanent anosmia caused by intranasal zinc therapy warrant careful analysis of the therapeutic effects of zinc. METHODS: A search of the Medline database (including articles published during 1966-2006) for studies of zinc and the common cold produced 105 published reports. Fourteen were randomized, placebo-controlled studies that examined the effect of zinc lozenges, nasal sprays, or nasal gels on naturally acquired common colds. Eleven features of experimental design affecting signal quality, chance, bias, and blinding were used to evaluate the 14 placebo-controlled studies. These criteria were validated case definition, quantifiable hypothesis, sample size calculation, randomized assignment, double blinding, proof of blinding, measurement of compliance, measurement of dropout rate, analysis by intent to treat, description of methods of analysis, and measurements of probability. Equal weight was given to each criterion, because failure to meet any one could potentially invalidate the findings of a clinical trial. RESULTS: Four studies met all 11 criteria. Three of these studies reported no therapeutic effect from zinc lozenge or nasal spray. One study reported positive results from zinc nasal gel. Of the remaining 10 studies, 6 reported a positive effect and 4 reported no effect. Intent-to-treat analysis was the most common criterion not met. CONCLUSIONS: This structured review suggests that the therapeutic effectiveness of zinc lozenges has yet to be established. One well-designed study did report a positive effect of zinc nasal gel.

Laryngoscope. 2007 Apr;117(4):743-9.Click here to read Links

Olfaction and olfactory epithelium in mice treated with zinc gluconate.

Slotnick B, Sanguino A, Husband S, Marquino G, Silberberg A.

Department of Psychology, University of South Florida, Tampa, Florida, USA. slotnic@american.edu

OBJECTIVE: We assessed whether a nasal spray containing zinc gluconate (ZG) compromises the integrity of olfactory epithelium and olfactory function. METHODS: Axonal transport of horseradish peroxidase from olfactory epithelium to the olfactory bulb was studied in 2- to 21-day survival mice given intranasal injections of 2, 8, or 50 microL of ZG (approximately 4, 15, and 94 times the equivalent recommended human dose). Other similarly treated mice were tested using precision olfactometry to detect and discriminate odors. RESULTS: Anatomic changes were graded as a function of dose and survival time. Two microliter injections had no discernable effect. while the 50 microL volume produced substantial deafferentation of input to the olfactory bulb in short-survival cases. Nearly complete restitution of input occurred within 3 weeks. At each volume and survival time, zinc sulfate (ZS) had a greater effect. Behaviorally, 2 microL and 8 microL ZG-treated mice and those given multiple injections of 2 microL ZG performed as well as controls, whereas those given 50 microL were hyposmic but not anosmic. ZS-treated mice performed more poorly, and those injected with 50 microL were anosmic for the first 8 to 10 test days. CONCLUSIONS: A massive dose of a ZG nasal spray did cause a transient disruption of the olfactory epithelium and compromised olfaction. More moderate volumes, even those far in excess of a recommended dose, were largely without effect on odor detection and discrimination tasks. These outcomes fail to support the claims from recent clinical case reports that use of a ZG-containing nasal spray can produce anosmia.

Am J Rhinol. 2008 May-Jun;22(3):292-6.

Effect of ginkgo biloba and dexamethasone in the treatment of 3-methylindole-induced anosmia mouse model.

Lee CH, Mo JH, Shim SH, Ahn JM, Kim JW.

Department of Otorhinolaryngology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.

BACKGROUND: Olfactory loss is a challenging disease. Although glucocorticoid is sometimes used for the treatment of anosmia, it has been reported that it potentiated neural damage in the early phase of treatment. This study is designed to identify the effect of ginkgo biloba, an antioxidant that acts as a free radical scavenger, in the treatment of olfactory injury aggravated by dexamethasone. METHODS: Anosmia mouse model was induced by i.p. injection of 3-methylindole (3-MI). Twenty-five mice were divided into one control group without anosmia and four anosmia treatment groups (given treatments of dexamethasone and/or ginkgo biloba). The effects of treatment were evaluated by behavioral test, Western blot, and immunohistochemistry 2 weeks after 3-MI injection. RESULTS: Induction of anosmia was confirmed by behavioral tests. The thickness and cell number of olfactory neuroepithelium were decreased more significantly in the dexamethasone treatment group than in the combination treatment group. The expression of olfactory marker protein (OMP) in olfactory epithelium was more decreased also in the dexamethasone treatment group than in the combination treatment group. The expression of OMP was decreased significantly in the olfactory bulbs of anosmia groups but there were no differences between the anosmia treatment groups. CONCLUSION: Dexamethasone treatment was associated with further deterioration of olfactory injury by 3-MI and it was recovered by combination treatment of dexamethasone and ginkgo biloba. The antioxidant effect of ginkgo biloba might play a role in restoration of olfactory loss and it was effective only when oxidative stress is maximized by dexamethasone.

THE NEW YORK TIMES ARTICLE
http://www.nytimes.com/2009/06/17/health/policy/17nasal.html?_r=1&ref=health

F.D.A. Warns Against Use of Popular Cold Remedy

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Article Tools Sponsored By
By GARDINER HARRIS
Published: June 16, 2009

Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
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A Zicam nasal gel.
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The action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.

The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

Although the F.D.A. took no action during the Bush administration, Dr. Margaret A. Hamburg, who was named the agency commissioner by President Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”

The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the release said. “For this reason, Matrixx Initiatives believes that the F.D.A. action is unwarranted and will seek a meeting with the F.D.A. to review the company’s product safety data.”

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

The F.D.A. does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the F.D.A. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

But the government sometimes negotiated for days or weeks before companies agreed to recalls, leading many more consumers to be put at risk. And the Zicam case demonstrates that aggressive enforcement action can lead to disagreements.

An F.D.A. warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products “may pose a serious risk to consumers who use them” and are “misbranded.” Such language would normally describe a recall alert. The products have no proven benefits.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center. The law requires producers of approved drugs to forward to the F.D.A. all reports of product-related injuries, but Ms. Autor declined to say whether this reporting requirement applied to Matrixx.

“This disabling loss of one of the five senses may be long lasting or even permanent in some people,” Ms. Autor said. “People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life.”

Dr. Charles E. Lee, a compliance officer in the agency’s drug center, said zinc could be toxic to nerve receptors in the nose. In the 1930s, intranasal zinc was tested as a polio preventative, and some patients suffered anosmia, Dr. Lee said.
Tags: fda, homeopathy, medicine, olfaction, pharmaceuticals, vaccines, viruses, zinc
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