Top

FDA Links Zicam to Anosmia

June 16, 2009

Two and a half years after a lawsuit against the manufacturers of Zicam and Cold-EEZE nasal gels was settled in January 2006 in which the companies made no admission that their products had caused anosmia (loss of the sense of smell) in 340 plaintiffs, the FDA has determined that intranasal application of zinc gluconate, the products’ active ingredient, is in fact the likely culprit.

The FDA announced today (June 16, 2009), following over 130 additional complaints from consumers who claim to have lost their sense of smell, that it is recommending that people stop using all intranasal products made by Zicam that include zinc gluconate. Intranasal zinc has been known to devastate olfactory nerves in humans and other animals for years but, because zinc products fall under the homeopathic provision of FDA laws, these products were not required to get FDA approval before going on the market.

The FDA recommends that anyone who has any of these products stop using them immediately, and have sent a letter to Matrixx Initiatives stating that the company cannot market these products without approval and that they do not contain adequate warnings about the risk of the loss of one’s sense of smell.

Cold-EEZE discontinued its cold remedy nasal spray product in 2004 and is now only available as a lozenge and as an orally-dissolvable tablet, and is thus not affected by the FDA decision regarding intranasal sprays. The products which are included in this warning are:

Zicam Cold Remedy Nasal Gel (15ml)
Zicam Cold Remedy Nasal Swabs (20 count)
Zicam Cold Remedy Swabs, Kids Size (20 count)

The FDA believes these products are harmful and could potentially cause permanent loss of the sense of smell. They are especially concerned about this problem in children because it may be more difficult for them to effectively tell someone that the problem has occurred. While less debilitating than lost eyesight or hearing, loss of the sense of smell carries potentially serious health and safety implications–olfactory clues warn us to avoid spoiled foods, to shut off the gas, to get out of that burning building–and are essential to our enjoyment of food.

If you believe your sense of smell was affected by using Zicam, you should contact your healthcare professional. You or your healthcare professional should then contact the FDA either online or by calling 1-800-FDA-1088.

Comments

2 Responses to “FDA Links Zicam to Anosmia”

  1. John clisby on June 16th, 2009 9:15 pm

    Hello guys

    I had a bad bout of allergies this past spring and went to the doctor. He prescribed eye drops and a nose spray called Avamys. I was taking them for my allergies then, I got Bronchitis. I went to the doctor and he prescribed an antibiotic called some like clarthrimisen, (not sure of the spelling). after I recovered from the bronchitis, I lost my sense of smell and taste. Its been over 8 weeks now. I heard on the radio today about Zicam but thats not what I was taking.
    I love food and am very frustrated that I can’t smell or taste anything. boo hoo!!

    What to do?
    I live in Victoria, British Columbia, Canada
    I am 52, and healthy as a horse!
    Any help would be great! My life is toast now that I can’t taste. Instead of craving something, I tell my wife I’m craving to smell something!!

    Thanks.
    John

  2. liz on June 18th, 2009 12:43 pm

    I am so sorry about your sense of smell, John! :(

    I don’t have any information on the nasal spray that your doc prescribed for you, and the FDA has only specified Zycam nasal products, but if what you used contained zinc, then I think it would be a good thing to see your doctor and ask him what you should do. Actually, that would be a good idea anyway, as you aren’t able to smell or taste anything, and that must be very frustrating indeed!

    Also, here is the link to the FDA site with their contact information: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm
    I realize that you are in Canada, but they may be familiar with the particular nasal spray that you used and should be able to point you in the right direction to find some help.

    I wish you the best of luck in recovering your sense of smell!

Got something to say?





Bottom