Article: Zicam Recall

Discussion in 'General Health & Wellness' started by TwoCatDoctors, Jun 18, 2009.

  1. TwoCatDoctors

    TwoCatDoctors New Member

    FDA: Some Zicam Cold Remedies Are Risky
    Agency Warns That Zicam Intranasal Products Containing Zinc May Lead to Loss of Sense of Smell; Company Calls FDA's Action 'Unwarranted'
    By Miranda Hitti
    WebMD Health News
    Reviewed by Louise Chang, MD

    June 16, 2009 -- The FDA today advised people not to use Zicam intranasal products that contain zinc, because of the risk of anosmia (loss of the sense of smell), which may be long-lasting or permanent.

    The FDA's warning only applies to the following Zicam products:

    * Zicam Cold Remedy Nasal Gel
    * Zicam Cold Remedy Gel Swabs
    * Zicam Cold Remedy Swabs, Kids Size

    "Consumers should stop using these products immediately and should discard or return them," Deborah Autor, director of the FDA's Office of Compliance, said at a news conference. Autor notes that Zicam Cold Remedy Swabs, Kids Size is no longer on the market, but consumers shouldn't use the product if they still have it at home.

    Zicam's maker -- Matrixx Initiatives, Inc. -- has voluntarily withdrawn Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market, telling consumers to discard any of the affected products or request a refund by calling 877-942-2626 or visiting Zicam's web site.

    All of the products covered in the FDA warning are sold over the counter, contain zinc, and are administered into the nose as a homeopathic treatment for colds. The FDA considers the products "misbranded," in part because the product labels don't warn about anosmia risk.

    Autor noted that without the sense of smell, people "may not be able to detect dangers, such as gas leaks or something burning in the house, and may not be able to tell whether food is spoiled before eating," as well as having their quality of life diminished.

    Zinc can damage receptors in the nose that are needed for smelling, notes Charles Lee, MD, a medical officer in the FDA's Office of Compliance.

    The FDA has gotten more than 130 reports of anosmia in people using those products. Some of those people also reported a loss of their sense of taste, according to a warning letter the FDA today sent Matrixx Initiatives, Inc., the company that markets Zicam.

    In that letter, which is posted on the FDA's web site, the FDA states that it "is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products." The FDA has asked Matrixx Initiatives to share those reports with the FDA.

    The FDA has ordered Matrixx Initiatives to stop marketing the products without FDA approval, and to plan how to remove the products from the market, Autor said.
    Matrixx Backs Zicam's Safety

    In its news release, Matrixx states that "consumer safety is and has always been the company's top priority," and called the FDA's action "unwarranted."

    Matrixx 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."

    In the news release, William Hemelt, the acting president of Matrixx, says that the company "stands behind the science of its products" and that "there is no reliable scientific evidence that Zicam causes anosmia."

    Hemelt said the FDA's action came as a surprise. "Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products."

    FROM: http://www.webmd.com/allergies/news/20090616/fda-some-zicam-cold-remedies-are-risky?ecd=wnl_nal_061709
  2. JimB51

    JimB51 Member

    I lost ALL sense of smell after using it about 4 yrs ago. I sprayed it and sniffed it into my sinuses. BIG TIME.
    That was the problem. They gave No Clear Warning! It's probably OK if you spray a little in the TIP of your nose -ONLY. After all the lawsuits they stopped the spray and started using swabs.(but still wouldn't ADMIT that the spray was a danger. ARRG!! Those JERKS!!!

    Anyway, after TWO YEARS my sense of smell started coming back. and NOW I think it's almost all restored!!
    I'm so Thankful to have back what we all take for granted and what I missed so much.

    >>Also, thankfully someone came to the door when I was in bed. When I opened the door they yelled "WHAT'S BURNING"?? and ran in. The spaceheater was smoldering and plastic cover was melting. I went right up to it. Couldn't smell a thing! (They were all gagging).
    I had used ZICAM THAT NIGHT and a week earlier.
    The NEXT NIGHT I FOUND OUT WHY my sense of smell was gone.

    I Read a warning about ZICAM cold remedy - ON THIS BOARD !!!!
    Jim
  3. JimB51

    JimB51 Member

    I just searched for ZICAM on this board and FOUND several in posts about it in 2004 and 2005 - including my own posts after what happened to me. The FDA was WARNING about it way back then - but it was just NOW removed ??? UNBELIEVABLE !
    Jim!
  4. TwoCatDoctors

    TwoCatDoctors New Member

    Jim, I'm so sorry you went through what you did with Zicam. It does makes me furious too. I had wanted to try it and for some reason I never did--I'm glad I didn't. And you could have died from the fire or even suffered serious permanent respiratory damage from the heater burning down. Even the gas company puts a smell into the natural gas to help us know there is a gas leak. But if there had been a leak, you wouldn't even have known that.

    I am glad to know that you are getting some sense of smell restored and I agree this should have been recalled years back when the symptoms first started. Take care and keep letting us know how you are doing and if you get your smell back 100 percent.
  5. gapsych

    gapsych New Member


    He also has ties to the supplementary industry. I will also post an article about this.




    Published on Scientific Blogging (http://www.scientificblogging.com)

    Home > Culture > Humor > Rugbyologist > Festival of Idiots #1 - Orrin Hatch For Exempting Dietary Supplements From FDA Approval

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    Festival of Idiots #1 - Orrin Hatch For Exempting Dietary Supplements From FDA Approval
    By jtwitten
    Created Jan 28 2009 - 11:30pm

    SENATOR ORRIN HATCH (R-UTAH)

    Known for his various musical talents and having all his shirts custom made to fit an impossibly narrow neck, Hatch does not join the Festival of Idiots because he lost the Republican Presidential nomination to W.

    Senator Orrin Hatch wrote and strongly supported the Dietary Supplement Health and Education Act of 1994 (DSHEA). DSHEA stopped the previous FDA method of dietary supplement regulation (banning "unapproved food additives").

    Now, dietary supplements are not required to prove that they either are safe or effective before going to market. DSHEA does not allow dietary supplements to make "disease" claims, but does allow vague and unsubtantiated "structure and function claims" like "immune-boosting" or "maintains a healthy circulatory system".

    The FDA cannot even monitor that dietary supplements contain the ingredients they claim until a safety problem is reported.

    For endangering the health of his fellow Americans through his legislative efforts, we thank you, Senator Orrin Hatch.

    --------------------------------------------------------------------------------

    Source URL: http://www.scientificblogging.com/rugbyologist/festival_idiots_1_orrin_hatch_exempting_dietary_supplements_fda_approval
    [This Message was Edited on 07/06/2009]
  6. gapsych

    gapsych New Member


    For those who make the argument that conventional medicine can have harmful side effects, this is true. The medical profession is also fallible. Nothing is perfect.

    However, to choose between something that is based on science and how the body works verses something that has not been proven, don't know the side effects, if the dosages are reliable, if the fillers are safe, where the supplement comes from and may be based on faulty non scientific ideas of how the body works.

    For me that is not a hard choice.

    I am truly sorry that people have had side effects with conventional medications. Science is ever evolving. I had harmful side effects from a medication and it was reported to the FDA, but it has not made me turn around 180 degrees and make a leap in logic that all conventional doctors, treatments and medications are negative.

    I guess I do not understand the logic when people who bash conventional medicine discover a side effect from some alternative treatment or medication, yet don't turn against the alternative business industry to the same degree.

    This is not about the right to choose but safety.

    gap

    [This Message was Edited on 07/06/2009]