FDA Says Homeopathic Cure Can Cause Loss of Smell 452
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.'"
It's not really homeopathic (Score:5, Informative)
if it actually does anything at all.
Works both ways (Score:3, Informative)
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:Fucking idiots (Score:5, Informative)
http://www.google.com/products?q=zicam [google.com]
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.
Re:Question (Score:3, Informative)
Anosmic
Doesn't have the simplicity of blind or deaf, I know.
Re:Zicam is not homeopathic... (Score:5, Informative)
That's odd... Their website appears to be at odds with your reality. [google.com]
Not Homeopathic (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 [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:Works both ways (Score:4, Informative)
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".
Eh? Homeopathic? (Score:5, 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.
Re:Zicam is not homeopathic... (Score:4, Informative)
Zicam Allergy Relief Nasal Gel is an over-the-counter homeopathic nasal gel that provides safe and effective relief from the symptoms of hay fever and other upper respiratory allergies, such as runny nose, sneezing, itchy and watery eyes, nasal congestion, and sinus pressure.
(Emphasis mine). So they themselves definitely describe it as homeopathic.
What made me laugh was this later entry in the Q&A:
Q: Why could it take 1-2 weeks before I notice the effect of Zicam Allergy Relief Nasal Gel?
Zicam Allergy Relief Nasal Gel begins working from the first time you use it. While it is not understood why consistent use over 1-2 weeks is necessary to see results, clinical research on this product indicate that it may take one to two weeks to see a decrease in symptoms. For best results, use Zicam Allergy Relief Nasal Gel up to one week before contact to known causes of your allergies.
Not necessarily... (Score:5, Informative)
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]
Here's the meta-analysis (Score:3, Informative)
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.)
Food flavor etc. (Score:5, 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.
Re:Food flavor etc. (Score:4, Informative)
Re:It's not really homeopathic (Score:3, Informative)
Re:The skunk test (Score:2, Informative)
Re:70% of taste = 100% Myth. (Score:4, Informative)
Perhaps that is your situation and I believe you, but I doubt my grandfather fills in the gap 50 years later.
I can taste all those things fine, but it is not a memory, since I can easily discern quality in all these things, not just "this tastes like coffee, mmmm memory of coffee smell." I have a full range of likes and dislikes in coffee, bitters, sweets, carmely notes, stale coffee, strong coffee, my work serves starbucks and a better local brew, if someone fills up my cup with the starbucks blend not thinking there is a difference I can immediately tell, I cant smell coffee at all, my grandfather really is a wine connoisseur, he runs large taste testing events, you can't fill in the gap to taste the subtleties of wine, the casks they were aged in, etc.
Re:Why not give the FDA full control? (Score:3, Informative)
Check out Bayer's ad for Heroin, or the Cocaine Toothdrops.
Re:It's not really homeopathic (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.
Re:Fucking idiots (Score:3, Informative)
Since your claim is that the nerves are damaged, a quick fMRI [wikipedia.org] would prove that your brain is receiving signals from you undamaged nerves.
Re:It's not really homeopathic (Score:3, Informative)
You can get "Cebocap" in 3 different "strengths" (Red, Green, and Blue) at most pharmacies. They keep it on hand in case a doctor writes an Rx for a placebo.
http://www.walgreens.com/library/finddrug/druginfo.jsp?particularDrug=Cebocap&searchChar= [walgreens.com]
Re:Not Homeopathic (Score:3, Informative)
So cocaine is a homeopathic medicine?
Yes. But only if you dilute it until there's not a single molecule left in the sample you're selling as medication.
It'd probably be used against restlessness and insomnia.
Not homeopathic! (Score:3, Informative)
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.