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FDA Says Homeopathic Cure Can Cause Loss of Smell

Hugh Pickens writes "The FDA has advised consumers to stop using Matrixx Initiatives' Zicam Cold Remedy nasal gel marketed over-the-counter as a cold remedy because it is associated with the loss of sense of smell (anosmia) that may be long-lasting or permanent. The FDA says about 130 consumers have reported a loss of smell after using the homeopathic cure containing zinc, an ingredient scientists say may damage nerves in the nose needed for smell and health officials say they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. 'Loss of the sense of smell is potentially life-threatening and may be permanent,' said Dr. Charles Lee. 'People without the sense of smell may not be able to detect life-dangerous situations, such as gas leaks or something burning in the house.' The FDA said the remedy was never formally approved because it is part of a small group of remedies known as homeopathic products that are not required to undergo federal review before launching. The global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says it 'will seek a meeting with the FDA to vigorously defend its scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.'"

31 of 452 comments (clear)

  1. It's not really homeopathic by Anonymous Coward · · Score: 5, Informative

    if it actually does anything at all.

    1. Re:It's not really homeopathic by fractoid · · Score: 5, Funny
      True. Apparently it "contains zinc" - according to this fact sheet:

      While Zicam also makes zinc-containing oral cold remedies, these are not subject to this warning because the development of anosmia appears to be related to the intranasal application of zinc.

      Don't these guys know ANYTHING about homeopathic medicines? The strongest ones don't have any of the 'active ingredient' in them at all, you just take sugar pills and think happy thoughts at them until the sun shines out your ass.

      --
      Rampant carbon sequestration destroyed the Dinosaurs' tropical paradise. I'm here to help repair the damage.
    2. Re:It's not really homeopathic by MeatBag+PussRocket · · Score: 5, Interesting

      the interesting thing is that the placebo effect (which you are basically describing) is a very well documented medical fact. in some studies the placebo is actually more effective than the drug being tested, and its not because the drug sucks or that people are faking it. there is a huge misconception and stigma surrounding placebos. MDs prescribe them regularly. they _WORK_ . sure, its basically fooling your brain, but whats wrong with that? if you have a neuralgia or pain or dysfunction and somebody gives you a pill and the condition improves, what does it matter what the pill is made of? placebos should be preferred as they dont have side effects.

      --
      i wage a holy war against the apostrophe.
    3. Re:It's not really homeopathic by plover · · Score: 4, Insightful

      placebos should be preferred as they dont have side effects.

      I'm pretty sure this is incorrect. Granted, they're not very harmful, but you could easily experience things like dry mouth, headaches, muscle aches, etc. Remember, your body is reacting as though it received medicine. If someone gives you a placebo and tells you it's a cold remedy, you will probably experience the same side effects you experience with Sudafed.

      The prescribing doctor is the cause of the side effects: "Be sure to take these pills with lots of water and maybe a cracker or two, they're really powerful and give some people a bit of nausea."

      It's the sales job that makes placebos work, and part of convincing people that it's effective is to add that "powerful" tag. And nobody would believe a perfect pill with no side effects exists, or we'd all be taking them every day.

      --
      John
    4. Re:It's not really homeopathic by BobGarcia · · Score: 4, Insightful

      Homeopathy is the molecular analog to astrology.

      --
      Half of my words are lies. Neither you, nor I, nor anyone else, can tell which.
    5. Re:It's not really homeopathic by hairyfeet · · Score: 4, Insightful

      Not only that but I remember reading a study on the effect years ago(maybe someone can find a link? My Search Fu does suck) where they gave those in pain morphine for several days and then either gave them a placebo with JUST water, or one with water and a morphine blocker. Now since the morphine was already out of their system the morphine blocker should have had NO effect at all, yet those that were given the placebo without a morphine blocker experienced a reducing of pain while those given the morphine blocker experienced an INCREASE in pain.

      They tried these experiments with several other drugs and the results were the same. We really don't know WTF is going on when it comes to the human brain, not really. IMHO the placebo effect shows that we can never know with 100% certainty what a drug is going to do, becase the human brain can skew the outcome one way or another. That is why research on the brain and the electro-chemical reactions is so important. We really need to understand how the entire machine works to design effective drugs.

      --
      ACs don't waste your time replying, your posts are never seen by me.
    6. Re:It's not really homeopathic by assert(0) · · Score: 5, Insightful

      Randomized controlled trials is the only way to tell if it "*really* works". Anecdotes are worthless in evaluating (alleged) cures. For every useless substance there is, you *will* find users who "used to be skeptics" but now "swear by them", falsely convinced they "*really* work". Because of post hoc ergo propter hoc, spontaneous remission, false diagnosis, placebo effect, confirmation bias and a slew of other fallacies.

      Evangelists like yourself and peers with poorly developed critical thinking skills (ie. most humans) are the exact reason these "cures" are still around - despite having no biological plausibility and negative RCT results against them.

      --
      (founded 95,000,000 yrs ago, very space opera)
    7. Re:It's not really homeopathic by lxs · · Score: 5, Informative

      True homeopathy is the alleged "science" of diluting a substance with water until there is nothing left but water. Only the "memory" of the water having contained the stuff remains. (look up dr.Emoto for more wacky antics surrounding the memory of water. Emoto by the way has a real doctorate but not in a field relevant to his research.)

      Many alternative medicines are promoted as homeopathic when they are nothing of the sort.

  2. If I hadn't used so much Zicam Cold Remedy.... by xiao_haozi · · Score: 5, Funny

    If I hadn't used so much Zicam Cold Remedy I would say this smells fishy.

  3. Re:Fucking idiots by clarkkent09 · · Score: 4, Informative

    It seems to be still on sale though:

    http://www.google.com/products?q=zicam

    Quick, buy it, pretend that you lost a sense of smell (let me see them prove otherwise) and then wait for a nice settlement check. Just kidding, that would be dishonest.

    --
    Negative moral value of force outweighs the positive value of good intentions.
  4. Pull it off the market by sqrt(2) · · Score: 4, Insightful

    This product needs to be removed from the market. I'd like to see stricter controls on things like this. Anything that attempts to cure or prevent disease needs to be evaluated and tested by the FDA. All supplements, vitamins, these cold prevention products should all have to shown to be safe and do what they claim BEFORE they can be sold.

    --
    If you build it, nerds will come. Soylentnews.org
    1. Re:Pull it off the market by geekboy642 · · Score: 5, Insightful

      Are you genuinely claiming to be too stupid to tell the difference between a curative and a vice? Here's a hint, on the tobacco label, there's generally a warning saying "Tobacco will kill you". On this zinc "medicine", there's no warning label saying "Warning: will permanently disfigure you", and the manufacturer peddles it as being both safe and effective.

      --
      Just another "DOJ fascist authoritarian totalitarian bootlicker" -- Zeio
  5. Re:Anosmia? by Anonymous Coward · · Score: 4, Funny

    "My dog has no nose."

    "How does he smell?"

    "Awful!"

  6. Re:Zicam is not homeopathic... by chefmonkey · · Score: 5, Informative

    But Zicam is not a homeopathic remedy, and was never marketed as such.

    That's odd... Their website appears to be at odds with your reality.

  7. Not Homeopathic by KeithIrwin · · Score: 5, Informative

    The odd bit of this story that no one really seems to be reporting is that this medicine, although sold under the "homeopathic" provisions of FDA regulations (and thereby bypassing the normal approval process), is not a homeopathic medicine as the term is usually used.

    If you go read the wikipedia entry on Homeopathy, you can see that the way homeopathic medicines are made involves taking a substance and then repeatedly diluting it with water, alcohol or sugar. Most homeopathic medicines are diluted repeatedly until the level of dilution is such that statistically, there is unlikely to even be a single molecule of the original substance remaining. Homeopaths consider higher levels of dilution to be more powerful. They generally believe that the water "remembers" the shape of the original substance.

    The Zicam nasal spray is only diluted 100:1 (2X or 1C on homeopathic scales), meaning that it is within the range of normal dilutions used in preparing drugs for delivery, not diluted to a level used in homeopathic remedies. It's being governed by rules meant to only cover placebos, but at that concentration, it's not a placebo. It's a real drug which can have real side effects. If the rules have allowed this drug to come to market legally then those rules have a huge loophole and need to be fixed ASAP. But no one seems to be noting that.

    1. Re:Not Homeopathic by fusellovirus · · Score: 4, Insightful

      This is loophole that needs to be filled. a detailed discussion why is here

  8. Re:Zicam is not homeopathic... by artor3 · · Score: 5, Interesting

    Well, you're right that it's not really homeopathic, but you're wrong about it never being marketed as such. In fact, the word "Homeopathic" appears right on the front of the box, as is plainly visible here.

    However, the concentration of the active ingredient is around 2%, whereas the concentration in a true homeopathic "cure" would be approximately 0%. Basically, they marketed an unproven drug as homeopathic, when it wasn't, in order to get around FDA regulations.

  9. Eh? Homeopathic? by Wolfbone · · Score: 4, Informative

    Homeopathic quackery is infamous and justly ridiculed for the fact that its 'remedies' contain exactly no active ingredients and - unsurprisingly - also have exactly no biological effects. This zinc based stuff is obviously not homeopathic.

  10. Not necessarily... by denzacar · · Score: 4, Informative

    According to the warning letter the solution contains "an active ingredient measured in homeopathic strength--Zincum Gluconicum 2X".
    2X equals to 1:100 solution - which may be quite a significant dosage of the "active ingredient", depending on its nature.

    Incidentally, this is not the first time this particular maker of this particular homeopathic drug has been a cause of this particular health concern.

    --
    Mit der Dummheit kämpfen Götter selbst vergebens
  11. Re:Question by pyrrhonist · · Score: 4, Insightful

    One thing you can be sure of is that a kid with these all problems sure plays a mean pinball.

    --
    Show me on the doll where his noodly appendage touched you.
  12. Better scent than anything else. by Aphoxema · · Score: 4, Interesting

    I've lost my smell to nasal polyps and chronic sinusitis years ago, it's a little disappointing sometimes but sometimes it's nice not having to smell awful things.

    I've heard that when you can't smell you can't taste, which is bullshit. I can't tell the difference between some things but I do very much have a vivid sense of taste still.

    And you know that "You lose one sense you gain another" thing? It doesn't work with smell.

    --
    "Most people, I think, don't even know what a rootkit is, so why should they care about it?"
  13. i can totally see this happeining by FudRucker · · Score: 4, Funny

    husband: honey, i have a cure for those smelly farts i have
    wife: thats nice dear, Beano?
    husband: no, this is better just one sniff and your cured forever

    --
    Politics is Treachery, Religion is Brainwashing
  14. Zicam is not homeopathic. by robbak · · Score: 4, Interesting

    Homeopathic remedies (which I prefer to call homeopathetic...), as others have stated, are diluted until there is a low to zero probability of them containing 1 molecule of substance.

    This is stated to be a 1:100 dilution, which is 1% active ingredient: a significant concentration of a proven active (and detremental) ingredient.
    There use of homeopathic labels (2X, which means 2 dilutions of 1: 10) was done simply to avoid FDA attention, and they are likely to get into deep trouble because of it.

    --
    Prediction for end of Universe #42: Fencepost error in Quantum_bogosort.cpp
  15. Homeophobic by Roger+W+Moore · · Score: 5, Funny

    Don't these guys know ANYTHING about homeopathic medicines?

    Clearly not - they must be homeophobes.

  16. Food flavor etc. by interactive_civilian · · Score: 4, Informative

    Usually my sense of smell does but one thing: annoy me.

    I highly doubt that. You just don't realize what your sense of smell is doing for you. For example, about 70% of what you think of as "taste" when you are eating food comes from your sense of smell. Without a sense of smell, your food will taste rather bland and you probably wouldn't be able to appreciate the more subtle flavors (and definitely the aromas) of various foods. Try it yourself. Next time you are stuffed up with a cold, try eating one of your favorite foods and see if it is still as full of flavor as you remember.

    While humans don't use pheromones as actively as other animals, the sense of smell still plays a big part in arousal (and in stopping arousal, to be fair). Good smells make sex better. You do want to have better sex, don't you? (insert the "oh wait, this is slashdot" quips here).

    And finally, all those things that annoy you about sense of smell are probably also helping to save your life. It lets you know that something is wrong (bad air, bad food, bad place, etc).

    So, for a person's overall quality of life, I'd say that the loss of the sense of smell is a pretty big deal. It is not one of the senses I would want to lose. I'd rather lose my ability to hear.

    --
    "Empathise with stupidity, and you're halfway to thinking like an idiot." - Iain M. Banks
    1. Re:Food flavor etc. by ctmurray · · Score: 4, Informative

      My sister lost her sense of smell after a bad cold. She can't smell natural gas, so this can be a serious issue. Later I read the smell of fire or burning things is quite useful as well. She had to get special natural gas detectors for her house (like smoke detectors - a loud shrill when set off). She mentions that food has no taste either.

  17. Re:There is more to it than meets the eye by alexhard · · Score: 4, Insightful

    The plural of anecdote is not data.

    Even if you for some reason choose to ignore the science known as chemistry, data acquired in a good manner shows that homeopathic "medicines" have no more effect than a placebo. It most definitely does not work.

    Being a "skeptic" achieves not being fooled into taking placebos instead of proper drugs, which can save your life in many cases.

    --
    Infinite time means everything that can happen, will. You being you is absolutely incidental. You do not exist.
  18. Re:Why do people even take pharmacudical drugs? by ScentCone · · Score: 4, Interesting

    The body has phenomenal healing capabilities

    Sure, except when it doesn't, or is faced with a wound or pathogen that the body simply can't handle.

    if people expanded their horizons and stopped popping Advils or taking Zicam when they aren't feeling well and taking another root (natural medicine, anyone?), It's guaranteed society would notice a difference

    Ah, so you know of a root that is an analgesic, or which has anti-inflammatory properties? That's nice. Can you tell how to provide exactly the right amount of that root, prepared in exactly the right and consistent way, to produce just the anti-inflammatory effect needed without also causing liver or kidney trouble, or provoking an allergic response? Really? So, can you explain to a couple hundred thousand local witch doctors exactly how to predictably prepare, store, and dispense that substance so that anyone traveling can be sure they're getting just what they know will work, no matter where they go? I see, so we need some standards for preparation and dosing, just to be safe? I know, let's call those "pharmaceuticals."

    I know precisely how much Ibuprofen will relieve a handful of aches and pains that I can routinely get from certain physical activities. I can find it anywhere, and bank on the results. I'm glad that I don't have to go into an "alternative medicine" shop and get what I hope will be the right sort of powdered root extract from a guy who also promises me that ground up rhinocerous horn will improve my love life.

    --
    Don't disappoint your bird dog. Go to the range.
  19. Re:There is more to it than meets the eye by laughingcoyote · · Score: 5, Insightful

    If you want to convince us that homeopathic medicines work, than by all means, put one of them through a rigorous, controlled clinical trial. (Not one anecdotal bit that may or may not be true and if it is may or may not be coincidental.) Tell one group they're getting the homeopathic "medicine" and give that to them. Tell the other group that's what they're getting and give them a placebo. Compare the results. That's how accurate results are obtained about the effectiveness of an actual drug against the placebo effect.

    If you find significantly better results in the side that took the "medicine" than in those who took the placebo, and those results prove to be repeatable, you may have yourself a case. But until someone is confident enough in the method to submit it to rigorous, controlled testing, rather than "It worked this time! Really! Don't be so closed minded!", it's just quackery preying on the gullible.

    When proponents of something are quick to tout its benefits and quick to ridicule its critics, but even quicker to duck rigorous testing that would show for sure if it really works or not, I become very closed minded very quickly. I've never taken Zicam, so apparently I can still smell bullshit just fine. If you're that confident in it, put it up for FDA approval.

    --
    To fight the war on terror, stop being afraid.
  20. Re:There is more to it than meets the eye by SQL+Error · · Score: 5, Funny

    Seemingly there is no reason for it to work at all, yet there are people who get results by taking it.

    I had a cold. I stayed in bed and ate chocolate for a couple of days, and my cold went away. From this I learned that (a) chocolate is a cure for the common cold and (b) having a cold causes you to gain weight.

  21. Re:"Proper" drugs aren't that great either. by Citizen+of+Earth · · Score: 4, Interesting

    Not taking "proper" drugs can save your life too. It's a bit of a toss-up.

    Only rhetorically. If taking "proper" drugs kills you one in 10,000 times and not taking them kills you 9 times out of 10, then it is not a "toss up", meaning 50%-50%. Is there a one-word term for "blindness to orders of magnitude"? Most ideologues seem to suffer from it.