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Zicam Removed From Shelves by FDA PDF Print E-mail
Swift
Written by Jeff Wagg   

ziscamIn a far too infrequent moment of proaction (or is that proactivity?), the FDA announced that they have

issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

What’s the problem? Oh, nothing much… it just seems that using their product even once can permanently remove your sense of smell. And while we’re not canines, and rely mostly on our visual sense, losing your sense of smell is a great way to increase your risk of death through fire, food contamination, or the over-consumption of durian.

Matrixx’s response is what you’d expect:

Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products.

I wonder how convincing the non-scientific data is. That's the stuff that seems to be on the outside of the box.

Randi has covered Zicam a couple of times, here and here. And while skeptics are right to revile Zicam, which claims to be homeopathic but actually isn’t (it contains actual active ingredients, like zinc), this proclamation isn’t something we can celebrate too heartily.

We rely on the FDA to keep our food and drug supply safe, and this case, though they’ve finally reacted to public outcry, they failed to stop a dangerous product from going to market and being widely sold for a decade. This could be an example of science correcting itself, or it could be an example of a homeopathic loophole, where drugs labeled “homeopathic” are governed under a different set of rules than actual medicine. From the about.com article:

although conventional prescription drugs and new OTC drugs must undergo thorough testing and review by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to homeopathic remedies.

Remember the terms “safe and effective”? How do they apply to Zicam? Consumer Reports was on to them in 2006, reporting:

More important, studies with animals and case reports suggest that nasal zinc may cause loss of smell, possibly permanent. Last year we unearthed more than 200 complaints to the Food and Drug Administration about an impaired sense of smell, taste, or both after using zinc nasal products. And about 340 consumers have sued Matrixx Initiatives, the maker of Zicam, claiming loss of smell. Last January the company agreed to settle almost all outstanding lawsuits without admitting fault. Matrixx’s promotion of Zicam is being investigated by the Federal Trade Commission, which regulates product advertising.

Gee, where does Matrixx mention that in its "scientific data"? And it seems like Matrixx was aware of the FDA's interest three years ago... and yet they mention "surprise" at the FDA's "sudden" action.

So kudos to the FDA for recalling a dangerous product, but wow, it would have been nice to have caught this dangerous “alternative” medicine before it was released to the public. Maybe a lesson can be learned.

By the way, if any of you have some Zicam gel or nasal swabs at home, here's how you can get a refund:

Contact Zicam at 1-877-942-2626 or visit www.zicam.com to request a refund.

Try to avoid the propaganda on the site though.

 

 

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written by The_Libertarian_Otaku, June 17, 2009
I've only used Zicam once, and my nose still works fine.

Hopefully, other nasal sprays (Read: Saline sprays) are safer than Zicam.
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written by Noadi, June 17, 2009
Glad I've never used this stuff, my sense of smell is poor enough already.

I'm pretty sure you don't need to worry about salt water (saline) but I always check the ingredients anyway.
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I lost my sense of smell!
written by Mike L., June 17, 2009
I am a hard-nosed skeptic these days, but back in 2005, I used Zicam for a cold. This coincided with a loss of my smell sense. At the time, I made no connection between the two (although the smell thing really concerned me), until I heard reports of the link and found out the same thing had happened to my dad after using Zicam. Although I maybe should have seen a doctor or filed some sort of report or something, I didn't. My dad's smell returned after about a year, but mine is still as bad as it was in 2005. Anyway, I was very happy to see the FDA come out so strongly about this yesterday, and although I've pretty much come to terms with the damage, I feel a bit vindicated. Since, however, I've avoided any product that was not adequately tested by the FDA, and am as convinced as ever that homeopathy is complete, and often dangerous, rubbish.
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Durian
written by bigjohn756, June 17, 2009
Durian, yumm. I was in a room in China where a durian was being butchered. I had to leave because it smelled just like a long dead dog I once encountered on a busy street corner in downtown Barquisimeto. If I couldn't smell things, I could have eaten either the durian or the dog without knowing the difference. Urp.
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written by kenhamer, June 17, 2009
In a far too infrequent moment of proaction (or is that proactivity?),

Living in a land far, far away (Canada) I suppose it's not really my place to comment. But it's not like that ever stopped me before. So...

It seems to me that many US government agencies have in the past been hampered by the political interference of so-called free-enterprise politicos and proponents. However, with the new administration and the current antipathy towards "unbridled free enterprise," perhaps there will be more announcements like this in the coming days/years.
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written by kenhamer, June 17, 2009
I'm pretty sure you don't need to worry about salt water (saline) but I always check the ingredients anyway.

Hmmm... if you did the homeopathic dilution thingee on salt water would you eventually end up with a pillar of salt?

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written by Willy K, June 17, 2009
Yeah... what about the FTC? Can't they get these bullcrap homeo-toxic potions off the market? Isn't selling snake oil a crime?

Or like our Canadian friend, kenhammer, says are they days of "unbridled free enterprise" soon to have some reasonable limits? smilies/cry.gif
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Zicam settled a lawsuit about this in 2006
written by paulhutch, June 17, 2009
Over at What's the Harm .net, the homeopathy page has a story for Lisa Weatherington & 339 others about a $12 million settlement for loss of smell due to Zicam back in January 2006.

Mike L., if I were you I'd be calling a percentage lawyer and going after Zicam. Given how long your sense of smell has been gone it may never come back. With the FDA's action and the previous history a lawsuit should be a slam dunk.
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written by DKrap, June 17, 2009
Hopefully, this will send a message to everyone that uses homepathic products that there is a great potential for harm from these "medicines". Anyone buying something that is designated as a homeopathic product on the label is buying useless junk. There are so many other products like this on the market, most don't do anything at all but empty your wallet, that the financial crisis for health care could probably be solved if people stopped wasting money on these worthless concoctions and spent the money on science/fact based medicine. Maybe some of the victims of this company will appear on Oprah and blast homepathy like never before. Maybe Oprah should take up the cause to eliminate this garbage from the shelves of the nation's pharmacies. Just wishful thinking...
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Homeopathic Rat Poison
written by Realitysage, June 17, 2009
If they sold it, someone would probably buy it.....
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How is this homeopathic?
written by GeorgeP, June 17, 2009
Obviously since this preparation has an effect, it is by definition not homeopathic. In fact, it's dilution level is 2X, or 1:100, which is in line with actual medication. Is this some glaring loophole in the FDA rules? Do you only have to declare whatever you're shilling as "homeopathic" and forgo FDA screening? Can someone legally sell a 1X solution of hydrochloric acid as homeopathic eye drops with the FDA powerless to do anything about it?
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written by patrick767, June 18, 2009
Besides the risks inherent in not having a sense of smell, that's got to really screw up one's enjoyment of food because much of our sense of taste is closely tied to our sense of smell. That's a high price to pay for using a totally unregulated "safe" product.

I recall years ago a friend of the family who had never had a sense of smell telling us how one day he drank a whole bottle of caro syrup and loved it. Maybe he was just an oddity, but I always assumed that his lack of a sense of smell damaged his taste for food enough that something that would be intolerably sweet to most of us was fine for him.
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written by Alan3354, June 18, 2009
Ralph Nader had a book about 40 years ago detailing the ineptitude and uselessness of the FDA.
They haven't changed much, if any.
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Before we condemn the FDA..
written by garyg, June 18, 2009
...it should be noted that "dietary supplements" were excluded from FDA
oversight ca. 1994 (until they proved harmful) after lobbying by their manufacturers,
supported by powerful members of Congress.

The FDA (and other regulatory agencies, especially financial) have been too underfunded
in recent years to do their jobs in a timely and thorough manner
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written by Ozy, June 18, 2009
Just another example of the inability of the government to provide useful services. Isn't it about time we tried for market solutions? It's worked well with electricity, among other things, and a private firm could hardly be worse than the FDA, if for no other reason that an incompetent company would not, unlike the FDA, be able to enforce it's judgments by force of arms.
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written by Skemono, June 18, 2009
Isn't it about time we tried for market solutions?

Given that the problem is that the FDA doesn't regulate homeopathic trash, isn't a "market solution" pretty much what we already have? Which gave us hundreds of people who've lost their sense of smell, in addition to the people harmed by the hundreds of other unregulated items that have harmful ingredients.

So no, I don't see how the "market" is going to fix anything here. I don't think the solution is to scrap the FDA, the solution is to make it stronger, by getting rid of that stupid homeopathy exemption.
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Concerned
written by Dragonbrain, July 03, 2009
I find myself rather concerned about the comments I have seen here on the site about the FDA's actions with respect to Zicam. I expect subscribers to be rational and these comments have not been rational, nor, frankly, was the original article. I will have to make some assumptions here so bear with me. If we assume that there is no overlap between the complaints and those who have sued Zicam, and that they have all been harmed by the product, there are a total of 540 documented cases of anosmia due to Zicam use. If we assume that this is only a third of the actual total, since there is a gap between reportage and incident frequency, there are 1620 people who have been harmed by using this product. It is not unreasonable to assume that in a population of 300,000,000, Zicam has some fraction of 1% of the population using their product; for simplicity's sake, let's assume 1,620,000 people in the US. That means that the incidence of anosmia that can be attributed to Zicam is less than .1%; manufacturers of modern pharmaceuticals aren't even required to report incidents this low in the common literature (though they frequently do and they are required to report all incidents to the FDA and in the technical literature).

Now keep in mind that the above is a very conservative estimate: the number of people using it is probably higher; those people have not used it only one time; the number of incidents may be lower; we assumed that all of them were harmed by the product, etc. Most importantly, the common cold, which people are likely to have when they use this product, is the most common cause of anosmia.

Compare this against the wonder drug, aspirin. Over 600 people a year DIE from aspirin (usually from overdose but I don't get the impression that those making comments think people should be allowed to take care of themselves or judge for themselves whether or not to purchase and use a product). What about Reyes syndrome? I can't imagine the comments if Zicam were linked to the development of a deadly disease in children.

I should also note that whether or not Zinc Gluconate works is not in question here. Zinc and Vitamin C have both been shown to help the body fight off viruses, including the common cold.

Finally, it may very well be that some people have been harmed by this product because of a relatively rare set of factors. Viturally every product has the potential to harm someone. There are people who are allergic to sunlight. Peanut allergies were recently in vogue. I, myself, get migraines from aged cheeses. Should these things be banned? Should the government be "proactive" and rip them off the shelves (or force us all to stay indoors)? Of course not. And from everything I can tell, Zicam should also still be on store shelves available to anyone who believes it works for them and has not harmed them.

Thank you for your time and attention.

Sincerely,

Dragonbrain
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written by Steel Rat, July 09, 2009
Yeah... what about the FTC? Can't they get these bullcrap homeo-toxic potions off the market? Isn't selling snake oil a crime?


We can only hope so, and that Al Gore will be brought up on charges.
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