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Medicine Science

FDA Says Homeopathic Cure Can Cause Loss of Smell 452

Posted by samzenpus
from the make-sure-to-keep-that-poultice-wet dept.
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.'"
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FDA Says Homeopathic Cure Can Cause Loss of Smell

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  • by Anonymous Coward

    Seriously, I get a cold, I can't smell anything either. So really, it seems I'm damned if I do, damned if I don't.

    • A common cold goes away after 10 days at most. Then the sense of smell will come back.
      That nasal gel can damage your nose nerves so you lose the sense of smell for a long time if not for the rest of your life.

      It is quite a difference, quiaff?

      Even worse, the sense of smell and taste are combined so you would also lose a part of your taste sense.

  • by Anonymous Coward on Wednesday June 17, 2009 @09:57PM (#28368691)

    if it actually does anything at all.

    • Re: (Score:2, Funny)

      by Rynor (1277690)
      It's funny cuz it's true
    • by fractoid (1076465) on Wednesday June 17, 2009 @10:10PM (#28368789) Homepage
      True. Apparently it "contains zinc" - according to this fact sheet [fda.gov]:

      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.

      • Homeophobic (Score:5, Funny)

        by Roger W Moore (538166) on Wednesday June 17, 2009 @10:50PM (#28369051) Journal

        Don't these guys know ANYTHING about homeopathic medicines?

        Clearly not - they must be homeophobes.

      • by MeatBag PussRocket (1475317) on Wednesday June 17, 2009 @11:27PM (#28369269)

        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.

    • by denzacar (181829) on Wednesday June 17, 2009 @10:26PM (#28368897) Journal

      According to the warning letter [fda.gov] 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. [wikipedia.org]

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

    • Re: (Score:3, Informative)

      by ResidntGeek (772730)
      In this case, yes, it is. It's a homeopathic solution of several ingredients, but contains a normal (non-homeopathic, i.e. effective) dose of an actual medication, zinc gluconate.
    • by BobGarcia (603334) on Thursday June 18, 2009 @01:24AM (#28369949) Homepage Journal
      Homeopathy is the molecular analog to astrology.
  • Works both ways (Score:3, Informative)

    by vigmeister (1112659) on Wednesday June 17, 2009 @10:02PM (#28368731)

    Homoeopathic medication consists of almost only inactive ingredients. The so-called active ingredients are typically diluted beyond the point of having any real effect. In this case, that could be an excellent defense for Matrixx.

    http://www.youtube.com/watch?v=Xd23gBkhf9A [youtube.com]

    Cheers!

    • Re:Works both ways (Score:4, Informative)

      by oneirophrenos (1500619) on Wednesday June 17, 2009 @10:14PM (#28368819)

      Homoeopathic medication consists of almost only inactive ingredients.

      Well the active ingredients can actually have pharmacological effects, whether beneficial or adverse, but like you said the point is that they are often diluted so much that there is not a single molecule of the active ingredient left in the solution. However, there are different dilution ratios used, and some products actually aren't diluted enough for the effects to disappear, which can be dangerous as apparently was the case with this particular "medicine".

    • Re: (Score:3, Insightful)

      by PieSquared (867490)
      The notation for homeopathic dilution is #X where 1/(10^#) is the percent concentration of the "active" ingredient. Typical strengths of 10X or even 100X are so small that they have no effect. In Ziacam, however, the active ingredient is Zinc, and the dilution is 2X. A 1% solution isn't dilute enough to completely discount effects when you're spraying it into your nose several times a day for several weeks.

      Basically, zicam only calls itself homeopathic (and it may have other "ingredients" diluted to ho
  • by xiao_haozi (668360) on Wednesday June 17, 2009 @10:03PM (#28368735) Homepage Journal
    If I hadn't used so much Zicam Cold Remedy I would say this smells fishy.
  • Repeat (Score:2, Interesting)

    by Foxxxy (217437)

    Since when did Slashdot become CNN's day after repeat? Must be a slow geek week as this isn't the first repeat

    Zicam [cnn.com]

  • by sqrt(2) (786011) on Wednesday June 17, 2009 @10:05PM (#28368751) Journal

    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.

  • No sense of sight: Blind
    No sense of hearing: Deaf
    No sense of touch: Numb
    No sense of direction: Lost :-)

    No sense of smell: ???
  • by PoiBoy (525770)
    This warning only applies to the version of Zicam that you stick in your nose. When I have a cold, I use the lozenges that dissolve in your mouth, and I swear they really do help control the symptoms of a cold.
  • Not Homeopathic (Score:5, Informative)

    by KeithIrwin (243301) on Wednesday June 17, 2009 @10:13PM (#28368811)

    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 [wikipedia.org], 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.

    • Re: (Score:3, Insightful)

      by robbak (775424)

      You ninja'd my comment!

      Yes, I hope that the FDA acts quickly on redefining 'Homeopathic' as dilutions over a certain level (1ppm perhpas, the chemical equivalents of 3C) before one of these companies actually kills someone directly.

    • Re:Not Homeopathic (Score:4, Insightful)

      by fusellovirus (1386571) on Wednesday June 17, 2009 @11:15PM (#28369195)
      This is loophole that needs to be filled. a detailed discussion why is here [sciencebasedmedicine.org]
  • Eh? Homeopathic? (Score:5, Informative)

    by Wolfbone (668810) on Wednesday June 17, 2009 @10:16PM (#28368835)

    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.

  • by Aphoxema (1088507) * on Wednesday June 17, 2009 @10:32PM (#28368933) Homepage Journal

    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.

    • by lawpoop (604919)

      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.

      You haven't completely lost your sense of smell. You've just lost your ability to detect faint scents on the air. Putting something in your mouth, in the sense of smell, is like the difference between a misting spray-bottle and a super-soaker.

      What happens when we 'taste' is that 1. the tongue senses sweet, salty, sour, bitter, and perhaps savory [wikipedia.org]; and 2. chemicals waft up that hole in the back of the mouth to the olfactory tissue. Those two chemoreception processes taken together are what we think of as ta

    • by bitrex (859228)
      One of my friends in college with congenital anosmia was a lifesaver when, as often happened, someone would leave leftover takeout in the lounge refrigerator over a school vacation. He was well rewarded for performing cleanup tasks that anyone with a functioning olfactory system would have found unbearable!
  • by FudRucker (866063) on Wednesday June 17, 2009 @10:33PM (#28368945)
    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
  • For what it's worth...

    While I haven't used Zycam, I have, a number of times over the last few years, used zinc gluconate tablets (dissolved in the mouth and gargled up toward the nose) to try to mitigate an oncoming cold.

    And I have also noticed, over that period, a significant reduction in my sense of smell (which I hadn't connected with anything and assumed might just be due to age).

    Needless to say I'll be skipping the zinc treatments in the future, at least until this is resolved.

  • by robbak (775424) on Wednesday June 17, 2009 @10:35PM (#28368955) Homepage

    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.

  • by nbauman (624611) on Wednesday June 17, 2009 @10:38PM (#28368963) Homepage Journal
    http://www.ncbi.nlm.nih.gov/pubmed/10796643 [nih.gov]

    Cochrane Database Syst Rev. 2000;(2):CD001364.

    Update in: Cochrane Database Syst Rev. 2006;(3):CD001364.

    Zinc for the common cold. Marshall I.

    National Center of Epidemiology and Population Health, Australian National University, Canberra, Australia, 0200. marshali@health.qld.gov.au

    OBJECTIVES: Interest in zinc as a treatment for the common cold has grown following the recent publication of several controlled trials. The objective of this review was to assess the effects of zinc lozenges for cold symptoms.

    SEARCH STRATEGY: A search was made of the Cochrane Controlled Trials Register, MEDLINE, EMBASE and reference lists of articles. Searches were run to the end of 1997.

    SELECTION CRITERIA: Randomised double blind placebo-controlled trials of zinc for acute upper respiratory tract infection or cold.

    DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality.

    MAIN RESULTS: Seven trials involving 754 cases were included. With the exception of one study, the methodological quality was rated as medium to high. For most outcome measures different summary estimates were used across the studies to describe the duration, incidence and severity of respiratory symptoms. This limited the ability to pool results. Results from two trials (04 - Mossad; 08 - Smith) suggested zinc lozenges reduced the severity and duration of cold symptoms. However, there was significant potential for bias, and further research is required to substantiate these findings. Overall, the results suggest that treatment with zinc lozenges did not reduce the duration of cold symptoms.

    REVIEWER'S CONCLUSIONS: Evidence of the effects of zinc lozenges for treating the common cold is inconclusive. Given the potential for treatment to produce side effects, the use of zinc lozenges to treat cold symptoms deserves further study.

    (This meta-analysis was actually withdrawn, and I don't know why, maybe to evaluate more recent data.)

  • by sootman (158191) on Wednesday June 17, 2009 @10:39PM (#28368967) Homepage Journal

    It's much safer to stick with homeoerotic cures instead.

  • by jcr (53032)

    But this product has nothing to do with homeopathy. Homeopaths sell water. They don't do active ingredients.

    -jcr

  • by Wansu (846)

    Maybe they can sell Zicam to people who work around hog waste lagoons or people who pump out septic tanks.

  • I've met some people are fans of homeopathic remedies. Losing ones sense of smell could be a good thing.

  • I had an "FDA approved" drug once that right on the label said (paraphrasing) "WARNING: Can eat a hole through your stomach and kill you". That's not an exaggeration. And this was a pain medication. I never took one because despite it being "approved", I'd rather just deal with the pain then potentially kill myself.

    The FDA blocks shipments of e-cig nicotine inhalers that are basically 100% effective to stop people from smoking since people are still inhaling nicotine vapor as a replacement (note: it's no
  • by MartinSchou (1360093) on Wednesday June 17, 2009 @11:42PM (#28369353)

    It's not medicine. If it was medicine it would be labeled as such AND it would have a provable effect.

    It's water! How often does that need to be said? The only effect it has is as a placebo. And for those who believe that you can't overdose on homeopathy I have two terms for you: Water poisoning [wikipedia.org] and drowning.

  • Not homeopathic! (Score:3, Informative)

    by argent (18001) <peter@AAAslashdo ... minus threevowe> on Thursday June 18, 2009 @01:16PM (#28376295) Homepage Journal

    If it contains enough Zinc atoms to be detected (let alone have an effect) it's not diluted nearly enough to really be homeopathic.

    Not saying homeopathy isn't a scam, mind, just this once they're being abused by worse scammers.

"The vast majority of successful major crimes against property are perpetrated by individuals abusing positions of trust." -- Lawrence Dalzell

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