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Zicam Side Effects Linked to Loss of Sense of Smell: FDA Warns Against Use

The FDA is warning consumers not to use several versions of Zicam Cold Remedy after receiving more than 130 reports of people losing their sense of smell. Though the action has not been termed a Zicam recall, since the homeopathic product was never formally approved by the FDA, the popular over-the-counter nasal gel and swabs will have to undergo federal review before they can be sold again in the United States.

The warning was issued today for Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. Matrixx Initiatives, the maker of Zicam products, was told that they must stop marketing the cold remedies and submit safety and effectiveness data for review.

The affected Zicam products are delivered through the nose and contain zinc, which may damage nerves in the nose and result in a loss of the sense of smell as a side effect. The condition, called anosmia, may occur as early as the first dose and can be long-lasting or permanent.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said the FDA’s Janet Woodcock, M.D. “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

Zicam side effects have been associated with a risk of anosmia for some time, and the manufacturer, Matrixx Initiatives, has reportedly settled approximately 340 Zicam lawsuits filed by people who claim their sense of smell or taste was impacted by the cold remedy.

Zicam gel, containing zinc gluconate, is applied to the nasal cavity by spray or swab. The zinc can reduce the duration and strength of a cold, but it has also been commonly accepted that heavy use in one area of the nose can damage the sense of smell. The FDA warning on Tuesday notes that Zicam damage can occur with a single dose, however.

The 130 reports the FDA has collected since 1999, were all from physicians and consumers. The FDA received no reports from the manufacturer. A law passed in 2007 requires manufacturers to report consumer complaints and problems that indicate there may be a problem with their product. FDA officials have not said whether the company broke the law.

Zicam was not formally approved by the FDA because it was considered a homeopathic product; a marginally regulated class of over-the-counter medications which usually include natural herbs and minerals. However, because of the Zicam safety issues, the agency is now requiring formal approval before it can be sold.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marked for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER).

The FDA warning only indicated that three versions of Zicam were impacted, the Nasal Gel, Nasal Swabs and Kids Size Swabs. Other Zicam Cold Remedy products not currently impacted include RapidMelts, Oral Mist, Chewables, ChewCaps, Multi-Symptom Cold & Flu, Cough Spray, Cough Melts and Cold Sore Gel Swabs.

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12 comments

  1. patricia Reply

    I use zicam throat spray and have found it to be effective if I use it as soon as I have a sore throat. What i the “heavy metal” that is mentioned///I was unaware that Zinc is a heavy metal. Lets not demonize something that may be a good thing. People have been using zinc as a cold remedy for many years. I would like to see it tested by the FDA. THe herbal – homeopathic remedies should be allowed but after a 5- 10 year period then they should be tested by an independent source.

  2. Amy Reply

    We’ve used Zicam mouth spray before, and felt it helped shorten a cold somewhat. However, my sister is currently experiencing a numb throat and lack of taste from taking a chewable Zicam tab last night. After reading all the info, the potential for harm clearly outweighs the minimal potential good it does and this product should be pulled from the market. We will no longer use it and only hope my sister is not permanently damaged!

  3. Elsa Reply

    I have recently been taking Zicam in both mouth spray and tablet form in hopes to recover faster from the flu. Just tonight, day 5 of the regimen, I was noticing awkward tastes from familiar foods and wondering what was going on. I remembered the FDA warning about nasal spray Zicam, and quickly began researching Zicam side effects. I am really worried now about what I’ve done perhaps permanently!? Normal everyday foods and drinks are tasting bitter and weird.

  4. Julie Reply

    I have been taking zicam for a couple of years. i loved the nose swabs, now I am using the orange melt tablets and/or the mouth spray. I think it works awesome!! I’d like to here from Elsa again now that a couple of weeks have passed since you wrote on here….do you still have awkward tastes, or was it from the cold you had?

  5. Sandra Reply

    I used Zicam Oral Spray for one round of what I think was a common cold, in Fall of 2008 and began experiencing a change in my sense of smell soon after. Some normal smells were completely changed. As of this writing, Jan 10, 2010….I still have the same problem with certain smells. Some of this problem has improved, but most of it is still frustrating and on-going. I would not recommend the use of this product. I really liked perfumes and now can’t enjoy this anymore. I cannot smell common natural smells like leaves, grasses, lakes, rain, etc. Most of these smells we take for granted are still not available to me. I have seen an ear, nose and throat doc and my allergist and they told me that if it didn’t right itself within a year of onset….it likely wouldn’t. I am sorry I had this experience.

  6. David Reply

    I have used Zicam Oral Mist several times and it works well for me. Like everything else, it may not work for others. The FDA should focus on corrupt practices within their agency that allow drugs like Avandia to stay on the market in spite of proven life threatening risks. Zicam has not killed anyone. FDA approved drugs kill people on a daily basis. The FDA allows pharmaceutical companies to test their own products (even though they have been caught lying about the results). A watchdog agency is needed, but the FDA is a joke.

  7. Terri Reply

    I used Zicam Oral Mist several times and it had always worked well but recently after using it I experienced a burning sensation in my nose and now several days later the lining deep within my nose feels raw and dry. I feel the need to see a doctor since I am now having trouble sleeping due to not being able to breathe through my nose at night.

  8. Dave Reply

    Took only 3 of the tablets and now my mouth and tongue are still numb after 3 days. I am unable to close my mouth properly now. DON’T TAKE THIS STUFF!!

  9. Sheila Reply

    I’ve been taking the Zicam chewables for about a day now and I’m starting to not be able to taste things. My mouth feels weird. Like a burning sensation without the burning part.

  10. Conswella Reply

    Ok I am really scared I have been taking Zicam oral mist new cold remedy for one day now and I cant smell anything!!! At first I thought it was just due to my cold but after ready these stories Im guess its the zicam!!! I will not be taking this anymore and I pray to God that my sense of smell and test comeback!!!!!

  11. Donna Reply

    Just used the melt-away pills for a cold I was coming down with and It worked great….for the cold. A wee ago I noticed the top of the inside of my mouth is burning….BAD and it feels like it has been ripped up inside. It is very painful to both eat and drink. 7 DAYS NOW!! I was going to go to the doctors, but not sure if they can do anything. STAY AWAY FROM THIS STUFF!!

  12. ashley Reply

    Ok so I’ve been sneezing I decided to take meds to help me get better soon so I just took the oral spray about 30min-1 hour ago and as I’m floating my dishwasher I noticed how bad the after taste is. Then a few min later I feel like I’m about to like I put mop down run to like bc one way or another it’s coming out. I couldn’t stop it. I noticed that it was all fluid but the taste and after smell was horrible. Has anyone else experienced this?

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