FDA Warns Against Zicam Use
The Food and Drug Administration (FDA) has warned consumers to stop using the over-the-counter cold treatment Zicam after associating use of the product with potential permanent loss of the sense of smell (anosmia). The makers of Zicam say that stinks, arguing that the FDA lacked “reliable scientific evidence” to back up the warning.
Specifically, the FDA warned against the use of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size, after receiving more than 130 reports of loss of sense of smell by consumers using the products.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) in a press release. “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.”
The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.
Matrixx agreed to voluntarily recall the products, but has requested a meeting with the FDA to present and “defend scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.”
“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia (loss of sense of smell)," said William J. Hemelt, Matrixx Initiatives' acting president in a press release. “It is well understood in the medical and scientific communities that the most common cause of anosmia is the common cold, which Zicam Cold Remedy intranasal gel products are taken to treat. Given the enormous number of doses sold and colds treated, there is no reason to believe the number of complaints of anosmia received is more than the number that would be expected in the general population. There is no reliable scientific evidence that Zicam causes anosmia.”
- Kristina Duda, R.N., About Guide to Cold and Flu, presents the results of Zicam research in Can Zicam cause you to lose your sense of smell?
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Comments
My husband and I have been using Zicam nasal gel for several years and have never had any issues with our sense of smell.
It specifically says not to inhale it and just to let it sit in your nostrils for a few minutes.
If people have snorted it and experienced a problem, then that is not the fault of Zicam.
Apparently not one of the lawsuits have been won against Zicam.
My husband works in schools, touching nasty-dirty computers and he’s exposed to colds all the time.
If he uses Zicam gel in his nostrils at the very first hint of a cold symptom, it stops the cold in its tracks and he doesn’t get sick.
When I’ve been exposed to someone with a cold, I use it too. I have to avoid colds because I’m asthmatic and colds tend to go to my chest and put me in the hospital with pneumonia.
Neither of us has had a cold in several years and we owe it to Zicam…along with a good diet and regular sleep to keep our immune systems strong and functional.
We really hope Zicam is not taken off the market.
People really SHOULD follow directions for use!
I AM TOTALLY BUMMED! I swear by this product. I am a professional voice over talent and I am convinced that Zicam has helped me stave off colds and sore throats. I use it prophylactically before getting on airplanes and attending “networking” events or whenever I’m exposed to someone with a cold.
I had a dramatic reduction of the number of colds over the years I’ve used Zicam, especially when traveling, and it undoubtedly shortens the duration when I do get a cold. I have used it to swab the back of my throat when I feel a sore throat coming on and within hours symptoms are gone.
130 people lost their sense of smell out of how many millions of users of this product? And were they using it properly? Could there be other interactions that caused loss of smell? As a consumer, I’d like more information and the opportunity to make a my own decision just like I do before I take any drug or supplement.
How many people have contracted diseases from smoking cigarettes and the tobacco industry gets by with a black box warning on the label?
We could go on for weeks looking at the risks involved when taking all sorts of pharmaceuticals. I’d like to know the politics of why Zicam has been removed from the shelves. This is a product I feel so confident about its efficacy that I’m willing to take my chances with it, and I’d like to have that choice.
I think it’s funny how people always over react to things. I have a co-worker who will “never take it again” but smokes a pack and a half of cigarettes a day. Cigarettes=proven death Zicam=nothing. LOL This is why I hate you humans. :0
Yeah, this is just stupid. I am a teacher who has relied on Zicam swabs to help me breathe and therefore serve my students better when I have a cold. I have also used it to prevent a cold when exposed to a student who is sick. I have 100s of students, as I teach college biology! Taking away Zicam and allowing cigarettes to be sold is violating our freedom of choice! Call Washington and voice your complaints at the lack of logic in this!
Pulling zicam off the shelves is an outrage!!! All because a 132 idiots couldn’t read the box and follow directions. So dumb. I have relied on zycam for the past six years and my nose is fine. Better than ever since I quit smoking those deadly cigarettes that not only killed by sense of smell but taste as well. If you are going to take away a health remedy why don’t you flush all of the cigarettes too. So so stupid!
this is bs – zicam advertized on Rush and so they (socialist idiots ) went after this great product – how is hope and change working for you?
THIS IS DISGUSTING. The pharmaceutical companies know, as was reported some time back, that Zicam is more effective than Prescription anti-virals. I have been using Zicam for years, as I my immune system is compromised. I have not been laid up by a virus since starting Zicam use. (My entire family swears by it.) And, FYI, I am KNOWN for my sense of smell. I even had a perfume consultant at Nordstroms tell me that I should be a “smell”, someone who works with their sense of smell. We know without a dout that the prescription anti virals have far more side effects, so are they going to pull them off the market now too? It sure is strange that the FDA is doing this in the middle of a Pandemic……very strange. Insanely strange. Whose idea was this, anyway? Did the weigh the benefits the way they always do on Prescrition Medications? Are they being pressured by the drug manufacturers? Many questions here.
THIS IS REDICULOUS!!! DON’T MESS WITH OUR COLD REMEDY, FDA!!!! I AM SO UPSET ABOUT THIS BECAUSE ZICAM GEL HAS PREVENTED MANY COLDS THAT TURN INTO 2 WEEK SINUS INFECTIONS. I HAVE NOT HAD A SINUS INFECTION SINCE I STARTED USING ZICAM WHEN I FIRST FOUND IT ON THE MARKET. IF I GET SICK IT WILL BE THE FAULT OF THE FDA. IT HAS NEVER, I REPEAT, NEVER AFFECTED MY ABILITY TO SMELL. PLEASE BRING MY SAFEGUARD BACK!!!!
My family and I have been using Zicam nazal spray and gels for years, and it’s been the miracle cure against fighting colds and other viruses! Imagine how upset we were when they were pulled it off the shelves! My kids ages 8 & 11, have managed to stay healthy through every flu season, and my son have not had an asthma attack since he’s been cold/cough free. With the H1 and Influenza spreading rapidly in our community, it is an awful time to be without our Zicam Cold Remedy Gel! Please bring it back!!
Why was Zicam banned? If all these other pharmaceutical companies products are approved and carry such harsh side effects including death in some cases, why ban Zicam?
I think it works. I had a drastic reduction in the number and severity of colds. Everytime I get a bad cold this year, Ill thank the FDA. Yet another example of govt screw ups.
tc
I concur with the other commentors who back the use of Zicam. Considering the ridiculously long lists of possible complications or side effects for just about any pharmecutical product on the market, why can’t it just be listed on the product that it is to be used in accordance with the instructions? I can’t remember the last time I had a full fledged cold since this product has been available. And, I still have my sense of smell!