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Zicam Warning

Claim:   Zicam brand cold remedy causes a loss of smell in consumers who use it.

OUTDATED

Example:   [Collected via e-mail, October 2006]

I need to warn you about a product on the market and hopefully you will pass it on to as many people as possible.

I felt like I was coming down with a cold last Friday and because I'm around sick family members so much I wanted possibly head it off. I used Zicam, which is a gel nose spray which claims to keep a cold from becoming "full blown."

Immediately I had an intense, horrible burning in my nasal/sinus passages. The skin on my face hurt to touch and I had pain and burning so that it hurt to move my head. My husband was here and kept asking if I wanted to go to the ER but the thought of getting in a car was overwhelming. My face was burning hot and my nasal passages were so swollen that I couldn't breathe through my nose and I could see the swelling when I looked in the mirror. It lasted for about three hours and it was Labor Day weekend and I couldn't see a Dr. until Tuesday.

I have seen two ENT specialists in the last two days because I have lost, totally lost all ability to taste or smell. They both told me the same thing and suggested an immediate course of action. This is called "chemical trauma' and most times is permanent. I'm going to have a CT scan on Monday and am on a high dose of the steroid, Prednisone for two weeks. If there is even a thread of the olfactory nerve left, it will help to rejuvenate what is left.

I have been on the Internet (just put in Zicam) and there are hundreds of people who have had this happen. I am so angry and devastated and saddened right now that I don't know how to get through this. I cannot handle the thought of never tasting food again or trying a new recipe or smelling a Thanksgiving turkey. Cooking has been an absolute passion of mine for as long as I can remember and at the moment I don't see the point of even putting dressing on a salad.

I keep thinking that this cannot be happening to me. I suck on a lemon, bite down on a clove of garlic, smell a bottle of ammonia, nail polish remover, anything. I'm starting by telling people I love. PLEASE don't use Zicam, tell your friends.
 

Summary:   This item refers to two zinc gluconate-containing products, Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel, that were withdrawn from the market in 2009 and are no longer sold.

Origins:   Zicam Cold Remedy Gel was a gel taken through intranasal administration and advertised as shortening the duration and severity of colds. Many anecdotal accounts, like the one quoted above, linked its primary ingredient, zinc gluconate, with anosmia (loss of smell).

Matrixx, the manufacturer of Zicam, maintained in a 2004 statement that in "no clinical trial of intranasal zinc gluconate gel products has there been a single report of lost or diminished olfactory function," and that anecdotal reports of loss of smell connected with Zicam likely spring from the coincidental condition that cold remedy users are already at increased risk for anosmia:
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.

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.
Matrixx issued an update in January 2007 in which it reasserted the safety of its Zicam products:
Matrixx continues to believe that Zicam Cold Remedy intranasal gel does not cause loss of smell and that claims to the contrary are scientifically unfounded and misleading. The company believes that upper respiratory infections and nasal and sinus disease are the causes of the smell dysfunctions reported by some consumers. One of the most common causes of smell disorders is the cold itself, the very condition the product is used to treat. Others are sinusitis and rhinitis, conditions which are sometimes present when the product is used. The company’s position is supported by cumulative science, and it has now been confirmed by a multi-disciplinary panel of scientists and the decisions of four separate federal judges evaluating the scientific evidence in seven cases.
Because Zicam is labeled as a homeopathic remedy and is based on a naturally occurring mineral (zinc) that is generally recognized as safe, the product has not been regulated by the U.S. Food and Drug Administration (FDA) and has been exempt from government standards regarding safety testing and manufacturing that apply to regulated drugs. Medical reports going as far back as 1938 have noted that high doses of zinc can harm the tissues involved in smelling, but whether Zicam users experience a higher-than-normal incidence of anosmia remains a subject of debate. (Some critics maintain that whether Zicam poses any health risks is a moot point; the product should be avoided due to a lack of evidence that it is actually effective in treating or preventing colds.)

Three company-funded studies of Zicam failed to turn up any unusual rates of anosmia, but the studies were conducted to test the product's effectiveness (not specifically to investigate potential links to anosmia), and side effects are not always evident until a product is used by a much larger audience than the sample sizes involved in those studies (400 people each). Product liability lawyers representing
plaintiffs in lawsuits against Matrixx asserted that Zicam "destroyed delicate smell tissue when the drug's pump bottles drove the viscous gel into the top of the nose with propulsive force," but Matrixx countered by stating that the spray is only supposed to be used in the lower part of the nose and does not reach high enough into the nasal passages to inflict the type of damage claimed. (In Fall 2005, Matrixx changed Zicam's packaging to include a new "control tip sprayer" that prevents the gel from being forcefully expelled from the bottle. The company maintained that the new sprayer had been in the works for several years and that its introduction was unrelated to current litigation against the company.) Matrixx has stated that the anosmia experienced by some Zicam users was likely caused by viruses rather than the product itself.

So far, only one lawsuit against Matrixx over Zicam-related anosmia has gone to trial; it was settled in mid-2005 for a payment of undisclosed amount. In January 2006, without admitting any fault, Matrixx agreed to pay $12 million to settle a class-action lawsuit brought on behalf of 340 Zicam users who claimed they experienced loss of smell after using the cold remedy product.

In June 2009, however, the FDA issued an advisory cautioning consumers not to use Zicam brand nasal gel and nasal swabs because the agency "has received more than 130 reports of loss of sense of smell associated with the use of these Zicam products." The FDA also issued a warning to Matrixx informing the company that it could no longer market the specified nasal products until those products have been subjected to safety testing and FDA approval.

In response, Matrixx issued a statement asserting that its products are safe and that the FDA's actions were unwarranted. Nevertheless, it has withdrawn the products in question from the market.

Additional information:
    Matrixx Initiatives Reaffirms Safety of Intranasal Zicam Cold Remedy   Matrixx Initiatives Reaffirms Safety of Intranasal Zicam Cold Remedy
    Zicam Maker Settles Lawsuit Over Users' Loss of Smell   Zicam Maker Settles Lawsuit Over Users' Loss of Smell
Last updated:   22 February 2012

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Sources:

    Boodman, Sandra G.   "Paying Through the Nose."
    The Washington Post.   31 January 2006   (p. HE1).

    Boodman, Sandra G.   "Zicam: Smelling Trouble?"
    The Washington Post.   11 April 2006   (p. HE3).

    Davis, Erin Cline.   "An Element of Mystery in Zinc Cold Treatments."
    Los Angeles Times.   19 November 2007.

    Doheny, Kathleen.   "Fliers Try to Keep Colds at Bay with Remedies from A to Zinc."
    Los Angeles Times.   27 March 2005.

    Consumer Reports.   "Zicam: Safe Cold Cure?"
    January 2007   (p. 47).

    FDA.   "FDA Advises Consumers Not to Use Certain Zicam Cold Remedies."
    16 June 2009.