FDA Warning: Some Zicam Products may Impair Smell

The U.S. Food and Drug Administration (FDA) has warned Matrixx Initiatives to stop selling three over-the-counter Zicam® products, marketed as cold remedies, after more than 130 people reported developing long-lasting or permanent loss of smell (called anosmia). The warning applies to: Zicam Cold Remedy Nasal Gel®, Zicam Cold Remedy Nasal Swabs® and Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement released to the public. “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.”

Matrixx Initiatives will need to receive FDA approval in order to continue selling Zicam® products that are administered through the nose.

“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 marketed for minor, self-limiting conditions like the common cold,” Deborah M. Autor, director of CDER’s Office of Compliance, said in a public statement.

Healthcare professionals and consumers are encouraged to report adverse events that may be related to the use of these products to the FDA's MedWatch Adverse Event Reporting program.

For more information about zinc, please visit Natural Standard’s Foods, Herbs & Supplements database.

Comments

[Kara]

The sad part of this whole episode is that many people will make Zicam a scapegoat for all alternative or complementary medicines. If you look up the symptom of anosmia, it can occur for several reasons (including nasal infections and use of intranasal preparations). Making a blanket condemnation of all homeopathic drugs is counterproductive.

[Carrie]

Is there a high-risk population for these adverse effects? I have been using zicam sparingly for years and have not developed any loss of smell associated with the drug. Maybe overuse of the drug is what is causing the anosmia.

[Bebe]

Zinc is the contributing factor that is causing anosmia in such drugs. Zinc is toxic to nerve receptors in the nose; however, ingestible forms of zinc that are found in dietary supplements do not seem to have the same effect since the dose reaching the nasal nerve receptors is relatively low.

[Vera]

It usually takes a lot for the FDA to take a stand against a product, so I feel this does say something about the use of Zicam products and the related adverse events. Nearly all drugs/alternative medicines/supplements have side effects, so I would also keep that in mind. Zinc does may be effective for a variety of conditions based on the NS monograph, but in terms of its use for the common cold, the evidence is conflicting, which is something else to consider when evaluating this product.

[Becky]

While I see Kara's point that the Zicam warning might seem like it condemns a class of drugs, you could look at this from the flip side: If the makers and marketers of alternative/natural/homeopathic medication want the public to have faith in their effectiveness and safety, they should be willing to undergo the same processes that other drug companies are required to go through. In the long run, I think this would instill more consumer confidence and boost the popularity of these alternative approaches.

[Maddie S]

I agree. Ultimately, the FDA has the healthy interests of us in mind when they make decisions and administer warnings. To include CAM in common medical therapies, the products need to undergo the same scrutiny as other compounds regulated by the FDA. It is also important for them to properly educate the public so that we can make educated decisions regarding what we put into our bodies, or in this case, up our noses.

[Jen]

130 reports really doesn't seem like that many to me when I think of all the people who use Zicam products. I'd guess about 60-70 percent of the people I know use it if they feel a cold coming on, and none of them have experienced any negative effects. Maybe it has to do with how often you use it or how far you stick it in your nose?

Just to be on the safe side, I probably will stay away from these nasal products. The sense of smell doesn't always seem like it's that important, but it really affects your sense of taste. Think about how unappealing food can be if your nose is all stuffed up. I would hate to have that happen long term.

[angel]

On the zicam Web site, it's mentioned that patients can return their zicam products for a complete refund or exchange them. The Web site also mentioned that the FDA warning and withdrawal only concerns 2 of their cold remedy nasal products. Meanwhile, the "other 17 other zicam-branded products (including oral Cold Remedy, cough, sinus, extreme congestion and allergy products) are all safe and effective and will remain on retailer shelves" http://www.zicam.com/.

To be on the safe side, I won't try the other zicam products that are still on the shelves.

[rachel]

I would also be curious to know if there was a certain threshold of use for the anosmia to occur in the patients using Zicam. I wonder if they were chronic users of the product or if any of the episodes occurred after only a short duration of treatment. I know some people who swear by this product, but I probably will avoid it just to be safe. Sense of smell, while sometimes regarded as not as important as some of the other senses, actually is extremely important. As Jen pointed out, it can greatly affect taste, and it can also hinder your ability to assess for potentially spoiled foods and toxic fumes. I remember reading about a man who had lost his sense of smell and who consequently had many negative impacts in all areas of his life. It was something I hadn't really thought about before, but it really opened my eyes to just how important sense of smell is.

[Buy Accutane]

On the zicam Web site, it's mentioned that patients can return their zicam products for a complete refund or exchange them.

[Summer]

I was actually wondering the same thing about whether the 130 people were chronic users of these Zicam products. I would think anosmia would occur with more chronic use, but it may also happen with just a couple uses. The company should look into that, and if needed, should place a warning of some sort on the products indicating the appropriate treatment period.

[Claudie]

I agree with Summer that some people can get anosmia with just a couple uses. Some people may be more sensitive to the zicam product than others. I wonder how long zicam products have been in the U.S. market? Does anyone know?

[t]

Many people would agree that most medications cause some degree of adverse events, but anosmia is one of the more serious side effects. I personally don’t like to take brand new medications or alternative medications because of the long-term side effects. Despite the FDA approval, the long-term effects of medications are unknown until thousands of people take it for many years. This issue with Zicam is a good example of such a case.

[Amy]

I am curious as to what percent of Zicam users developed this impaired smell in order to determine the magnitude of damage that has been done. Also, it would be interesting to conduct a retrospective study on those people who developed anosmia from using Zicam products compared to people who did not develop this adverse effect. It may be possible that these people may have used the product in a certain way, at a specific frequency or in conjunction with other factors that may have promoted the development of anosmia. I am sure the company would benefit from such an effort to make any clarifications to consumers about the use of the product and correlations with impaired smell.

[Bill]

This is a crazy side effect, and the worse part about it is that it may be permanent! I’ve personally used Zicam in the past to fight off colds, and this just scares me. I’ve always wondered how something that’s just formulated with zinc can help fight off a cold, especially if you have to squirt it in your nose. Why can’t you just take oral tablets?