FDA recalls popular cold remedy-Zicam


sneeze1If you are one of the consumers of commonly available and over the counter cold remedy, Zicam, be cautious – Zicam has been warned by FDA for posing health risk to the patients. Federal drug regulators urged to consumers to stop using Zicam Cold Remedy Nasal Gel and related products because they can permanently damage the sense of smell. 


What is Zicam?

Zicam is zinc based popular homeopathic cold remedy manufactured by Matrixx Initiatives Inc.  It is used to shorten the duration and severity of the common cold symptoms.  


Why FDA has sent warning letter to company that manufactures Zicam? smell 

Scientists say that Zicam contains zinc gluconate, an ingredient that can damage nerves in the nose needed for smell.  Therefore, it can cause a temporary or permanent loss of smell, known as anosmia. People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, thereby adversely impacting the quality of life.


The FDA considers the products “misbranded,” in part because the product labels don’t warn about anosmia risk to patients. About 130 consumers and doctors have reported a loss of smell after using Zicam products since 1999. Matrixx has received more than 800 complaint reports of Zicam users losing their sense of smell but the reports were not provided to the F.D.A., said Deborah M. Autor, director of compliance in the agency’s drug center.   Zicam’s web site.


zicam-nasal-gel-kids-sizeHow many Zicam products have received warning from FDA?

The FDA’s warning applies to the following Zicam products:

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

Huh! Kids size! Can you imagine your kid loosing a sense of smell at a young age by use of Zicam product?


What steps have been taken by Zicam manufacturer?

Matrixx Initiatives, Inc. has voluntarily withdrawn Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market after the FDA warning as they say that consumer safety is and has always been the company’s top priority. Matrixx announced that c

'Times New Roman';">onsumer safety is and has always been the company’s top priority. Matrixx announced that should discard any of the affected Zicam products or request a refund by calling at 877-942-2626 or visiting 


Matrixx Initiatives believes that the FDA action today was unwarranted, and there is no reliable scientific evidence that Zicam causes anosmia. zicam-homeopathic-medication


Why FDA has approved drug to launch into the market even after so many complaints?  

The FDA said Zicam Cold Remedy has never been officially approved because it is sold as a homeopathic product that generally contains herbs, minerals and flowers and company does not require FDA approval before selling it.


What is the opinion of Matrixx Initiatives on causing of anosmia by Zicam?

William J. Hemelt, Matrixx Initiatives’ president says that there is no casual link between its Zicam Cold Remedy products and loss of smell. The products are safe and don’t cause anosmia. The most common cause of anosmia is the common cold not a Zicam, and Zicam Cold Remedy intranasal gel products are taken to treat common cold.


He also mentioned that they have more than 10 years of experience with the products, demonstrating their safety.  Zicam Cold Remedy intranasal products were introduced in the market in 1999, since then over 1 billion doses have been sold by more than 35 million retail units to treat cold symptoms.


What drew my attention about Zicam and its manufacturer Matrixx is that the company did not inform 800 complaint reports to FDA.  To me that does not reflect Matrixx’s top priority being consumer safety.  One thing is certain that there are complaints being filed and 130 cases reported for anosmia.  It may be a conjecture at this point that Zicam can cause anosmia, but it is not reflected by statements from Matrixx that they have conducted any research to prove or disprove this theory.


The news about Zicam, FDA warnings and reviews given by various Zicam consumers on the web portals, I can say that take the information that Zicam is safe with a grain of salt and take precaution in using zicam products if you have in your home.  Matrixx Initiatives has already paid $12 million in 2006 to settle lawsuits with about 340 Zicam patients, which gives another reason to question safety of Zicam.  Be safe and healthy smelling!


Source: fda.gov/Zicam


2 Responses

  1. Crime Master Gogo says:

    Good post. The site link to the FDA warning web page is missing – We don’t want to be sued by Zicam, do we?
    Gogo – Mugambo’s Nephew

  2. Katherine says:

    Zicam has 19 total products and only 2 were targeted by the FDA for shelf removal. Zicam has many wonderful products that will continue to be on shelf, some are homeopathic and some are allopathic. They are all regulated by the FDA.

    Also, people need to be aware that whether it’s 130 or 900 consumer complaints, we’re still talking about less than 1% of total Zicam users over the past 10 years. That means upwards of 99% of users never had a problem using the product.

    None of the complaints to the FDA have been proven anosmia cases and there’s still no scientific link between Zicam and anosmia. In fact, the common cold IS the leading cause of anosmia which people take Zicam to treat. So how would a consumer know if they lost their sense of smell from Zicam Cold Remedy Intranasal products or from their cold?

    It’s also important to note that throughout the US, Lawyers have been recruiting clients, or as they call them, assets, to sue Matrixx Initiatives. Why? Matrixx is a small company and anosmia is a difficult complaint to prove.

    I use Zicam. Their cold remedy products have shortened the duration and severity of my colds. I use their Allergy products (that don’t contain zinc) in the summer months. I also use their Zicam Congestion Relief products with oxymetazoline when I have congestion. I for one hope they stay around for a long, long time.

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