FDA Issues Warning About Use of Zicam Cold Remedy Products

alg_zicamIf you are looking for a tort case that passes the smell test, this may be it. The Food and
Drug Administration has issued a warning consumers to stop using certain Zicam nasal cold remedy products because of a large number of cases where users have lost their sense of permanently.

Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs are subject to the warning. They are linked to anosmia, which is often diagnosed with smell test using scratch-n-sniff odor tests for such odors as coffee, lemon, grape, garlic, vanilla and cinnamon.

Notably, some of the cases involved permanent loss of smell after a single use. Matrixx Initiatives, which makes Zicam, is already the subject of various lawsuits, but insists that the risks are “unfounded and misleading.”

In its warning letter, the FDA stated:

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.[2] 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.

A homeopathic drug product marketed without an approved NDA is not subject to the enforcement discretion set forth in the CPG when there is evidence of a safety risk associated with the product, as is the case for the Zicam Cold Remedy intranasal products. Under these circumstances, the Agency enforces the Act’s new drug approval requirement, a provision that is essential to protect the public health by holding firms responsible for demonstrating, based on adequate and well-controlled clinical investigations, that a product is safe and effective for each of its intended uses before marketing it. Therefore, an approved NDA is required for the Zicam Cold Remedy intranasal products, regardless of their homeopathic status. 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).

Additionally, Zicam Cold Remedy intranasal products are misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), because their labeling does not bear adequate warnings regarding the risk of anosmia associated with the product. In light of this failure to bear adequate warnings, these products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), taking into account the considerations set forth in section 201(n) of the Act, 21 U.S.C. § 321(n).

Matrixx Initiatives stock plummeted with the action, here. A prior settlement also served to lower earnings and cause unease over the company’s products. In the past, the company has been aggressive in pursuing critics of the company alleging problems, here. The company created a website that has countered the latest allegations:

Although plaintiffs and their attorneys hoping for financial gain have sued Matrixx, no plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell. No well-controlled scientific study has demonstrated a potential cause-and-effect relationship between use of Zicam and diminished smell function. No court cases have revealed any reliable evidence of any causal relationship. All scientific research and all controlled scientific studies to date have shown that Zicam is not a likely cause of smell dysfunction, and all of the anecdotal speculation offered in court has been discredited as unrelated, unreliable or deeply flawed.

Lawyers have also created sites discussing the possible harm of Zicam products, here. The law firm of Parker & Waichman filed a lawsuit and claimed:

[I]n December 2003, the plaintiff began using Zicam Cold Remedy nasal gel to relieve her cold symptoms. After using the product as directed, however, she began to experience a loss of her sense of smell and her sense of taste and has never regained these senses completely. She has been diagnosed as having a permanent partial loss of the senses of smell and taste.

The loss of the senses of smell and taster can have very serious consequences aside from the obvious loss of the enjoyment and pleasure associated with the exercise of those senses. Danger areas documented by studies of people suffering from the loss of these senses include: cooking related accidents; exposure to undetected fires, smoke, or gas leaks; eating spoiled foods or toxic substances; and other situations where either of the senses is a primary method of detection of sensory information.

In addition, the loss of these senses can cause collateral damages such as to anyone engaged in a profession where smell or taste is a critical requirement (chef; taste tester; cosmetics and perfume industry; wine, beer, or spirits industry).

For the full story, click here.

27 thoughts on “FDA Issues Warning About Use of Zicam Cold Remedy Products”

  1. Carlyle writes: Hav you not noticed how having a blocked nose impairs the sense of smell.

    you meant to ask if I’d ever noticed how a stuffy nose impairs the sense of taste didn’t you?
    was this sloppy writing or an example of sloppy thinking?
    if you can’t get this simple analogy one wonders about the other more sophisticated ones you’ve attempted.
    and no. when I get a cold i can still taste the chicken soup. maybe its because I have preternaturally acute senses or maybe because I use anti-inflammatory medication to ease the symptoms or maybe i have a really good imagination.

  2. AY,

    My GF tried the Chantix to stop smoking and had a bad time of it too although I have another friend who swears by it. You know what they say, one man’s trash is another man’s treasure.

  3. rafflaw and Buddha,

    What are you all feeding the trolls today? I think they like you and want to get your attention. You guys must be special.

  4. Ya think this stuff is bad try Chantix. That is a major life altering set back for some. FAA has banned private and commercial pilots and the NTSHA had banned it OTR driver from taking it as well. Its still good enough for you and me though.

  5. Buddha,
    It looks like I woke up the trolls. I didn’t know there was a contest either!
    Troll Ken,
    Is it difficult to make up stuff and call it facts? It is astonishing that someone could be alive during the Bush regime and then claim that Obama is ignorant of history. I think you need to heed the advice of he FDA and stop sniffing that Zicam.

  6. GWLawSchoolMom.

    Most of what we think of as the sense of taste is in fact the sense of smell. Hav you not noticed how having a blocked nose impairs the sense of smell.

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