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. Lotta,

    My condolences.

    Raff,

    Congratulations! You’re one of the sickest Constitution, er, um, ah, turley worshipers. That quite an achievement considering you’re competing with seamus – his “unrightness” is legendary – and gyges – Resident Hedonist Extraordinaire. Keep up the good work. Honestly, I didn’t know there was a contest . . .

  2. Obama is rapidly proving to be the most power hungry untrustworthy piece of crap ever elected President in the United States.

    He is single handedly setting the world back 50 years with all his incompetence, ignorance of history, and barely concealed anger at America.

  3. Lottakatz,

    I am very sorry to hear of you kitty’s death. Thanks for the other info.

    I wonder why the trolls are using this thread!

    rafflaw,

    Get out of your parent’s basement and get a life!!!!

  4. Obama Losing Democratic Support on Walpin Firing

    Democratic Senator Claire McCaskill, who authored the 2008 legislation requiring a President to give Congress 30 days’ notice of a proposed firing of an Inspector General, and the cause thereof–legislation which Barack Obama co-sponsored!–says Obama flagrently broke the law in firing Inspector General Gerald Walpin:

    “The White House has negligently failed to follow the proper procedure in notifying Congress as to the removal of the Inspector General for the Corporation for National and Community Service.

    The legislation requires that the president give a reason for the removal. “Loss of confidence” is not a sufficient reason.”

  5. Obama Losing Democratic Support on Walpin Firing

    Democratic Senator Claire McCaskill, who authored the 2008 legislation requiring a President to give Congress 30 days’ notice of a proposed firing of an Inspector General, and the cause thereof–legislation which Barack Obama co-sponsored!–says Obama flagrently broke the law in firing Inspector General Gerald Walpin:

    “The White House has negligently failed to follow the proper procedure in notifying Congress as to the removal of the Inspector General for the Corporation for National and Community Service.

    The legislation requires that the president give a reason for the removal. “Loss of confidence” is not a sufficient reason.”

  6. rafflaw, you are the sickest of the turley worshippers here. Just stop posting and go get a life.

  7. Tangentially on topic:

    It’s all a regulatory problem; FDA as well as most regulatory Agencies have been gutted over the last 8-12 years and rehabilitating the existing regulatory agencies would put a lot of people to work and make us all more safe.

    IMO if you can afford it have your doctor write prescriptions for brand name medicine and pay the extra money:

    Remember the Melamine in cat food problem a year ago? One of my kitties got sick and died from kidney failure in about a 10 day time span so I ended up obsessing over the state of drug and food ingredient oversight and spent days on the Internet. One thing I found out was that while the active ingredients in generic drugs are Allegedly regulated the inert ingredients aren’t in any meaningful way. This is not the case with brand name drug formulations.

    What this means is that if a brand named drug used cornstarch as a carrier/filler for the active ingredient the generic (and keep in mind most drugs are produced overseas and imported, China and India are the major producers as I recall) may be formulated wit something else: flour, milk powder, sawdust, whatever is handy and cheap. While the active ingredient is OK the filler,carrier etc. may impede uptake or contravene the effects of the active ingredient.

    After I did that research I was so disturbed that I started asking my Dr. to prescribe brand named drugs and just chalk up the extra cost to my own regulation and oversight efforts.

    I’m not going to redo a lot of searching to come up with cites, I’m just not up to it, so you can take this posting ‘for what it’s worth’ as the professionals say and check it out yourself if you have generic prescriptions. I was concerned enough about what I found to start spending ‘extra’ money and silently cussing the government who should be doing this for me with my taxes, every time I get a prescription filled.

  8. mR. tURLEY,

    cARRIE PRAGEAN IS LOOKING FOR A GOOD ATTORNEY TO SUE THE CORRUPT INDEFENSIBLE CALIFORNIA MS UNIVERSE ORGANIZATION.

    wOULD YOU BE INTERESTED IN TAKING THE CASE? iT LOOKS LIKE A SLAM DUNK. tHE MANAGER OF THE cA mS uNIVERSE oRGANIZATION IS A RABID PRO GAY MARRIAGE GAY ACTIVIST. i THINK THIS CASE COULD BE WORTH MILLIONS TO MS. PRAJEAN.

  9. HEY TURLEY, HOW COME YOU HAVEN’T BEEN ON KEITH OLBERMANNS SHOW FOR A LONG TIME? IS IT BECAUSE WE HAD TO CUT THE GUEST FEES $50 PER SHOW BECAUSE WE ARE LOSING SPONSORS?

  10. The curious firing of Gerald Walpin gets … curiouser
    June 15, 2009
    Senator Charles Grassley has demanded records from the Obama administration over the dismissal of the Inspector General for Americorps and raises the possibility that Barack Obama broke a law he co-sponsored in the Senate that protects the independence of the IGs.

    The firing comes as the Obama administration cut a sweetheart deal with a major Obama backer that allows him to receive federal funding as mayor of Sacramento, and fails to repay taxpayers for the money Kevin Johnson admittedly took illegally

  11. White House throws Kennedy under the bus.
    June 16, 2009
    After the CBO reported that the Ted Kennedy sponsored health-care plan circulating in the Senate would cost at least $1,000,000,000,000 (a trillion) over ten years, Jake Tapper reports that the White House has hit full retreat, complete with backup beepers. Despite having President Obama on the road just yesterday in an effort to build support for the reform efforts wending their way through Congress, suddenly no one in the West Wing has ever heard of them:

    “This is not the Administration’s bill,” White House press secretary Robert Gibbs said in a statement following the Congressional Budget Office’s analysis of Sen. Ted Kennedy’s health care reform legislation, “and it’s not even the final Senate Committee bill.”

    In reality, there is no actual “Administration” bill.

    The CBO made that same point about the lack of finality. That’s why the report only prices those elements within the incomplete draft, which did not initially include a “public plan”. The cost for that — which the Obama administration demands as part of the final version — will likely push the final number much higher.

    Gibbs’ response demonstrates that, yet again, the White House has deferred the entirety of policy creation to Congress. Just as Obama did with his stimulus plan, the administration hasn’t offered any leadership on the issue. Instead, Obama makes himself into the Campaigner in Chief on policy speeches supporting legislation to which he remains oblivious until the CBO puts a pricetag on it. Don’t get me wrong: that’s great work if you can find it, traveling on Air Force One in the middle of a severe recession explaining how the President plans to spend ever-increasing shares of money none of us have. And it does fit nicely into his previous work experience, none of which required him to show any leadership or do any actual work outside stump speeches.

    Apparently responding to the CBO’s numbers and the ensuing criticism of the Kennedy bill, Gibbs continued, saying “what is clear is what will happen if we let political posturing stand in the way of reform again: exploding deficits, lob loss, dwindling benefits, and millions more Americans joining the ranks of the uninsured. That’s unacceptable, and that’s why stakeholders from across the spectrum are joining with President Obama to enact health care reform that finally gets costs under control and expands coverage – without adding to our deficit.”

    A plan that costs a trillion dollars won’t add to our deficit? Really? And adding a public plan on top of that won’t create an entitlement commitment on top of the collapsing entitlements of Medicare and Social Security, either. And the unicorns will run through the lollipop fields with the Easter Bunny to collect all of the lemonade raindrops for Peter Pan. Don’t forget to clap for Tinkerbell!

    Maybe someone should pull Ted out from under the bus, and ask him how it feels to get shafted by the administration for carrying its water on Capitol Hill.

  12. I lost my sense of smell and taste after a high grade fever. It was temporary, but believe me you want you senses… all of them.

    A sense of fair play is what these lawsuit happy people are missing.

  13. I just read about the City of Toledo ticketing people for parking in their own unpaved driveways.

    Now I read here; that “a large number of cases where users have lost their sense of permanently”.

    Hmmm. Is the mayor of Toldeo using Zicam? He lost his sense.

  14. I would be willing to bet that this is the fav of politicians who have a hard time realizing their rhetoric and their deeds do not pass the smell test.

  15. rofl

    Any drug that causes the user to lose “their sense of permanently” is most certainly inappropriate for OTC.

    That’s a one Hell of a side effect. 😀

  16. Imagine that. Fake medicine that doesn’t have to pass the standards normal drugs do hurts people. No one saw this coming.

  17. Yet another brilliant offshoot of the work of Senators Hatch and Harkin, who have worked tirelessly to exempt the supplement industry from proving either the safety or efficacy of their products. Science? Who needs science?

    Funny thing is, even the manufacturers of this product don’t know what they are making. They call it homeopathic, but if it was homeopathic it would have no active ingredient in it. It does: zincum gluconicum. Could it be that they know exactly what homeopathic means but are just using “homeopathic” as a marketing buzzword? Nahhhh.

  18. wow. I’ve been using this stuff for years and I think it really works to diminish cold symptoms.
    I know I’d mind losing my sense of smell but I’m not sure about my sense of taste. seems that’d be a pretty good weight loss remedy.
    actually I’m waiting for something you can spray on food to make it tasteless.
    not that I have a weight problem…. it’s just those same 10 pounds I’ve wanted to lose since like forever.

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