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The FDA (Food and Drug Administration) has issued a warning on three zinc-containing Zicam intranasal products. The Zicam recall goes into effect immediately, today, June 16, 2009, the products are being recalled due to more than 130 reports of anosmia, or loss of sense of smell after use. The three products in question are:
- Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
- Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
- Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
Zicam products have regularly been sold in pharmacies, in retail shops, as well as over the Internet. If you have these products in your home, it is imperative to stop using them immediately.
According to the reports received by the FDA, many users noticed anosmia, or loss of sense of smell after using the products one time; others stated that the condition occurred after several uses. The FDA is concerned that the condition may be permanent.
If you believe you have suffered any ill effects from using Zicam, you are encouraged to speak with your health care provider right away. The FDA also asks that consumers as well as health care professionals report all cases of anosmia, or the loss of sense of smell, to the FDA’s MedWatch program. You may contact MedWatch by phone at 1-800-FDA-1088.or online here: MedWatch
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Comments
My family has been using Zicam to ward off impending colds with good results for 6 or 7 years. None of us has ever had any negative side effects.
I have been using ZICAM for years and have educated everyone I know on the benefit's and not a one of my friends or myself have ever had any issues except for positives. I think it is their competitors complaining.
Zicam has worked wonders for my family's colds for years without a single problem. It's practically a crime to take this product off the market with virtually no real scientific evidence against it. This is a shocking abuse of power.
word, my nig.
zicam is awesome so S.T.F.U people against it
I can't believe this. Now I have years of colds to come. I love the stuff.
I too am amazed. /it has stopped almost every cold I felt coming on usually with just one dose. Same with family and friends. just used the last swab in my box and was thinking I needed to restock. Too late now.
It's been well known that the anosmia can be caused if you squirt it into your sinuses. The cases are likely the result of incorrect usage, possibly coupled with a genetic factor. The cotton swabs should be safe. Hopefully Zicam can show that the swabs are safe. I was always concerned that the introduction of the nasal spray would lead to this.
Wow, what an abuse of power - looking out for the millions when 6 or 7 people here swear by it! Do you people realize that "super germs" that antibiotics can no longer control have been caused by all your whiny baby antibacterial everything the last decade? Suffer a minor cold every year or two, build some antibodies, you whimps!
I agree with what's been said. Our family has used Zicam for quite a few years and it has always helped without any negative side effects. I hope the claims are found to be false. Perhaps those who have had problems used the product incorrectly.
I love the stuff--and it works- could it be the SHORT sellers in the stock market- they made a fortune today!
I used Zicam 2 years ago and haven't been able to smell or taste since. I have been to an ENT doctor for all kinds of tests and no cure. It stinks not to be able to smell or enjoy to taste of good food.
I too love the stuff. I swear by it and am glad that I still have some. I just used some swabs the other day when I was feeling a cold coming on. I say this is all going to go away after an investigation of the data for its use.
I used Zicam 2 years ago and have not been able to smell or taste since. I've been to an ENT doctor for several tests and nothing has changed. It stinks not to be able to smell or taste good food.
It's a shame when a product works so well that something like this can happen. I've used it for years. Let's see, two of the biggest conservative talk show host in America have Zicam as one of their sponsors. These host have said bad things about Obama's New Health Care Plan. Zicam keeps you from getting sick and having to use all those expensive flue and other drugs remedies that just cover the common cold, but don't cure it or prevent it like Zicam. Withour Zicam you might have to go to a Government doctor! Mmmmmmm just one person's opinion.
I wonder if it is just the spray or the swabs. I swear by the swabs, but the spray made me ill, I stopped immediately.
For all of you out there that think this is something new, IT IS NOT. I, too, have used Zicam on my 7 year old son but was warned at LEAST 3 years ago that it causes loss of smell and taste. He has been lucky, but you have to realize this has been coming for a LONG time. Not just since the nasal spray was released. I was warned when ALL they manufactured was the swabs. I tried a swab ONE TIME and had trouble smelling things so never used one again. And, Shula, super bugs only come from BACTERIAL infections. A common cold is a VIRAL infection. The Zicam just helps to build up, I believe, a zinc supply in your body to help you rid yourself of the VIRUS!!
I used to have really bad colds with secondary infections and then chronic bronchitis developed from all of that. I began to use Zicam zinc gluconate nasal spray every time I was exposed to people coughing or sneezing, and haven't had a cold for three years now. I do tend to lose my sense of smell for awhile after frequent use, but then it starts to return if I don't use it for awhile. I lose my sense of smell with colds, too, so what difference does it make?
I used to get so sick, it was becoming life threatening, so, really, even permanent loss of smell probably wouldn't deter me from using it. In any case, that is a decision I should be allowed to make myself.
If this is an example of the kind of medicine we will see with more government involvement, I may have to rethink my position on that....
:o(
I swear by this stuff! I used to get sick really easily but the Zicam swabs have kept me healthy for a long time now. I don't care if I loose my sense of smell as long as I'm not sick and miserable.
I have used Zicam for years. I started out using the spray and then the swabs. I believe all drugs and remedies have side effects. But some people abuse the use of these products because they do not follow the directions. For years I've seen people use more of a medication because they think it will give better results, however, it can do more harm than good. I say this for the all concern. Don't abuse because you might lose.
now I know , I have not been able to smell or tastes for the last month, I am hoping it goes away, I used Zicam at the start of my last cold just as the directions said
What about Zicam sinus relief spray? Is it part of the recall?
I have used Zicam for several months for sinus issues. In February I could not taste or smell. I have been to several allergy and ENT doctors and nothing has helped. I am having sinus surgery in 2 weeks. It has been horrible not being able to taste or smell. I have been told by several of the physicians that it may be permanent. I wish I had never used the product.
I Have used Zicam Nassal Gel several times in the past and never had a problem. With the last cold I felt coming on I used it twice and haven't been able to smell since then. I loved it too. Recommended it to friends and family. I'm glad they did not listen to me. Even if they don't take it off the market I'm happy to be warned of this side effect. I would rather endure a cold and take zinc orally than no sense of smell.
It isn't just anosmia (no smell) that can result from Zicam use but also parosmia (distorted smells) and phantosmia (a subset of parosmia, a lingering smell that won't go away no matter where you are or what you do). I used Zicam without problems for years but switched to the gel and wound up with parosmia, not anosmia. The world reeks of rotting meat, burning rubber, and foul smells that cannot be described. Every second of the day is so horrible you eventually just want to die to escape it. It's a hell you wouldn't wish on anyone. Zicam has been a culprit of this for years but, because it doesn't affect every single individual, it's been ignored. If it works for you as it once did for me, great. Just be aware it could go all wrong for you with the next cold. You do NOT have to misuse or incorrectly use Zicam for it to happen, and when it happens there is no going back and possibly no retrieval of normal smell again. Until you experience this, you have no idea at all how bad that is!
I've had sinus issues starting a few years ago. My sense of smell is greatly diminished. I have NOT used Zicam. How may people NOT using Zicam have diminished smell???? 130 people in the story (for now until the "now that I think about it crowd" joins in???? This is ridiculous. I'll bet many more than 130 have lost smell without using Zicam. Maybe NOT using Zicam causes loss of smell ability????????? THINK people. THINK. THINK.
Losing the sense of smell and/or taste is a very big deal. These senses are not there for our pleasure; they are there for our protection. Not being able to smell foul or rotten food, smoke from a threatening fire, and gas leaks(just to name a few) can be extremely dangerous, and cause serious illness, injury, or death. There is also the loss of enjoyment of eating good food.
I used zicam sinus relief nasal spray (not one of the recalled products) quite liberally for about one month. I lost my sense of smell and taste for 2 days(even when my nasal passages were clear),making me miserable, worried, & prompting me to visit my ENT. He assured me that nasal spray won't cause loss of sense of smell, but prolonged use makes sinus problems worse. Doctors don't know everything. I feel lucky that my senses came back. I don't KNOW that zicam was to blame, or inflammation the olfactory nerve. I do know that there are plenty of alternative zinc brands & products: losenges, chews, even gumballs.
Do you people not read! Many of the people who have lost their sense of smell and/or taste only used the product once. I have a friend who lost both sense of smell and taste 6 years ago. She was a part of a class action suite because if Zicam and is a nurse who knows how to take her medication. My father also lost his sense of smell after using the product for a few days. This is what happens when products don't have to be approved by the FDA. And for those of you who think it is better not to smell than to be sick. Get a clue, were talking that you will never ever smell rain, roses, or cut grass. It doesn't go away. To be sick for a week is much better than loosing your sense of smell/taste for the rest of your life! There are always people who miss use medications but this is not the case with Zicam!
Yes, it has helped , but I have not been able to taste or smell in the last 4 years . like others went to the Dr. had ultra-sounds etc. I carried this everywhere i went. I had a bottle at work, home , car. I had no idea I all I can do now is shake my head.... are you serious.
Does anyone know if this is pertaining to the allergy relief nasal spray, as well?
Thanks
I still have to wonder. My family has used this for years. It has worked very well for us all. None of us have lost our sense of smell. I cannot help but wonder if the 130 people who experienced this condition were predisposed. Naturally, still enough reason to pull from the shelf until further investigation can prove otherwise. But... I still wonder. Maybe people with certain conditions should not use it. Shame! It worked so well. Sigh, always something, isn't it?
How do I turn in what I have and get my money back
suzieshelton@aceweb.com
Hi Suzie,
At this point it isn't a full recall, where you would get a refund. It is a warning to stop using the products (the three listed) and a warning for the company to cease production. The FDA wants to govern their products due to the reported cases of anosmia.
My family has used this for years to. I cannot help but wonderd if the people who toke ths product, did not properly use it. The propably in halled it not using Zicam correct.
I have used the seasonal allergy relief ZICAM for at least 3 years. I have never had a problem and will not stop using it unless they stop making it. I had bad sinus headaches all the time, during allergy season until I started using it. I can't take other allergy medicine, because it makes my heart skip. I only use it in the morning and before bed, not every 4 hours as directed. I don't need it in the winter. I hope it is just the cold medicine because I just looked at the ingredients and it doesn't list Zinc.
I have been using Zicam since the first year it came out (gel). Follow instructions and have excellent results. No more cold or runny nose within 8-24 hours. It needs to be used correctly. Not when an individual feels like taking it. So many drugs are taken abusivly. There will always be side effects to people whenever we take, eat or live in enviroment of dust, pollen etc. I use Zicam religiously and only when I need it and when first signs of my cold or runny nose.
I have not had any problems with loss of smell. I can smell everything just like always. There are side effects on every drug,even if taken as directed. If people don't realize this by now, they don't use their brains and think what they are doing. Use medication only as needed and when you need it. As a pharmacy technician, you would not believe how many people abuse medications.
So put a warning on the package and let us move on. Have you heard the list of "potentially rare" side-effects they give on commercials for most medications? These often include serious issues such as heart problems. How many people have used Zicam with perfectly helpful results as opposed to the few (the article says 130?) who had this side-effect? (And you can actually lose your sense of smell from a really bad cold or sinus infection, by the way.) You can still buy cigarettes, which can kill you if used properly, but not a relatively inexpensive cold medication that many of us have found to be really helpful. (Before using Zicam, my colds often settled in my chest and became secondary infections, in spite of general treatments, so let us not be too quick to think, aaawwww just suffer for a few days.) My mother has had no sense of smell for over 50 years. (And she lost it due to allegeries.) I will be very unhappy if Zicam is pulled from the market.
Why no ban on Viagra? Supposedly there were 140 reported instances of partial or total blindness blamed on Viagra during a span of 4 years, prompting a warning not a recall. And yet with 130 reported cases of loss of smell blamed on Zicam in a 10 year period, why all of a sudden are bans and recalls being demanded? For people who have suffered a loss of their sense of smell for any reason, consider giving horse radish a few whiffs. Try it for a few days before giving up on it. Has anyone had their sense of smell restored by eating wasabi? Zicam has worked like magic for my family without any problems for years. I hope it stays on the market but with plenty of appropriate warnings.
How about the people that avoided serious complication from the colds that were lessened. People sometimes end up with pneumonia from colds. What "drug" can't have side effects? I've used it for years and I wish that had been able to grab some before it was pulled. I did follow the directions.
Has anyone noticed the attorney ads up already, asking if you've lost your sense of smell from Zycam? Jump on. I'm surprised pencils don't have a warning "USE ONLY AS DIRECTED, MAY CAUSE INJURY IF POKED IN EYE"
I have used Zicam gel for years with no problems. Every single thing known to man has negative side affects for someone somewhere. Even aspirin can cause a hemopheliac to bleed. Oh!! Recall all spirin!! Need I go on? Oh, water can be bad. Why do they keep insisting we drink a gallon a day?? More people have died from the common cold that people affected by Zicam. Its a risk you take by being alive. Why are farmers allowed to still grow peanuts??
Overnight, I lost my sense of smell. I had always enjoyed perfume for myself. It smelled stale and old, even though it was not old. I quit wearing it because I could not smell myself all day. A simple soda tastes like dust. That could be a good thing, I did not ask for it. I made a huge batch of spaghetti for friends, and almost threw all of it away becasue it tasted old and stale. My husband saved that batch. I could smell a diaper from miles away and knew to change my baby's diaper. I could smell a match to light a candle. I could smell microwave popcorn, and bacon mmmmmm yummy. I could smell my engine getting hot. I could smell rain. I cannot smell a dead skunk on the side of the road. Not anymore! I smell something but I cannot recognize it. I have three young boys and if they were into anything that they were not supposed to be in, I could smell it. I cook every meal from home. I no longer can taste my own cooking. Last year, I was able to smell/taste everything.
I have Zicam with a ext date of 10/07. It never occured to me to toss it as the date usually is a reference date for the store to sell it. Would I still be entitled to a refund?
I starting using Zicam about a year ago. With every application, I can feel a burning sensation radiating down to my throat. Although, a couple of months ago, I discontinued use because I was having trouble smelling my surroundings and usual smells. My daughter would even tell me, "mom you smell that odor", and I was like what....I also lost my taste. The food does not taste the same. Still, I didn't realize what was causing this reaction. Until, my daughter suggested, I stop using Zicam and realized it was a terrible side effect to the medication. Believe me, it does a lot of damage. I still cannot smell or taste my foods like usual. Sometimes, it takes a while to notice that you are losing your sense of smell because people might think they have a cold or it's just allergies.
SO, PEOPLE THIS IS A FACT: ZICAM DOES MAKE YOU LOSE YOUR SENSE OF SMELL AND TASTE. I AM JUST HOPING IT'S NOT PERMANENT, BUT SO FAR I'VE BEEN LIKE THIS FOR A COUPLE MONTHS ALREADY. IT'S VERY FRUSTRATING.
For those who did not get injuried, please don't look down on us, we went through an real stressfull ordeal, telling us that we complain is just plain rude and heartless
I used the Zicam spray several years ago and have not been able to smell or taste since. I went to two ENT doctors, had MRI and found no cause. Anyone that has not experienced this has no idea how it effects your life.
When ever a product works to good they pull it!
In ten years of use, 130 cases of loss of smell from Zicam.
From June 06-April 08, 7,802 adverse events from Gardasil: 15 DEATHS, 31 cases of GUILLIAN-BARRE SYNDROME. You don't see the FDA removing Gardasil do you? sOMETHING REALLY SMELLS HERE...
I feel for those who have been affected. I have felt the burning sensation years ago when I first starting using it. I have since found, as instructed, that it is not to be shot up into the nasal cavity, just applied to the insides of the nostrils. That's why the swabs work just as well. Anyway, I have 2 sons with asthma that is triggered by a cold virus. One son has spent several week long stints in the hospital as a result of a cold. Once was life threatening. The other would miss 2 weeks of school several times every fall. Zicam completely eliminated all that. 3 days of sniffles and they're done. No coughing, not even a trip to the doctor. Now it will be back to the hospital and all the attendance problems. I just wish there was a way they could put a warning on it or make it prescription so people could still take it if the benefits outweigh the risks. If you want to get rid of your old zicam, please sent it to me.
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