FDA Issues Warning for Over-the-Counter Cold Remedy ZiCam

[cassanova]

http://health.msn.com/health-topics/...0240535&page=1

TUESDAY, June 16 (HealthDay News) -- U.S. health officials on Tuesday warned consumers to stop using Zicam nasal cold remedy products because they can cause the loss of a sense of smell.

The specific products contained in the warning include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids' Size.

"These products claim to reduce the duration of the common cold and severity of cold symptoms," Deborah M. Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration, said during a morning teleconference Tuesday. "Consumers should stop using these products immediately."

The kids' products have been discontinued, but consumers may still have them in their households and are advised to discard or return them, officials said.

The products' manufacturer, Matrixx Initiatives, also received a warning letter and "must provide FDA with a plan on how it will remove existing inventory from the marketplace," Autor said.

"We have asked Matrixx in a warning letter to stop marketing the products, and we intend to work with them to address the products on the market and, at the same time, warn consumers to stop using and discard or return them," Autor continued. "We expect to hear a plan from the company."

According to Autor, the products have been marketed as homeopathic remedies and, therefore, have not needed FDA approval as long as the company complied with certain labeling and manufacturing requirements.

Now, the FDA is essentially asking Matrixx to take the unusual step of recalling the product, and then filing for new drug approval.

"The next step is for the company to come in and seek FDA approval if they want to continue marketing the products," Autor said.

"While the company has done trials involving small numbers of patients, we believe there have not been enough patients exposed in those trials to detect infrequent adverse events," she said.

According to Dr. Charles E. Lee, medical officer in the division of New Drugs and Labeling Compliance in CDER's Office of Compliance, the agency has received more than 130 reports from people using one of these zinc-containing products about the loss of a sense of smell, also known as anosmia.

"The loss of the sense of smell is potentially life-threatening and may be permanent," Lee said. "People without the sense may not be able to detect dangerous situations such as gas leaks, something burning in the house, or if food is spoiled before eating it. It also has a life-limiting effect, and can affect the livelihood of people in occupations where the sense of smell or taste is a crucial component."

Lee pointed out that, while the rate of adverse events seen here may not seem high, adverse events reports for over-the-counter drugs are historically low because consumers typically file their complaints with companies, not the FDA.

Until 2007, there was no requirement for makers of over-the-counter products to provide adverse event reports to the agency.

All reports of the latest problem have come from consumers and health-care providers, and Autor said the company has more than 800 adverse event reports related to the loss of sense of smell it has been asked to turn over to the FDA.

She declined to elaborate further on these reports, simply saying, "They have not been provided to the agency at this time."

Lee said the first reports of something amiss came in 1999, but seemed to speed up after 2004.

In 2006, Matrixx agreed to pay $12 million to settle several hundred lawsuits from consumers who claimed the zinc products had stripped them of their sense of smell. At the time, Matrixx said the settlements were not an admission of liability, the Washington Post reported.

According to Lee, both animal studies and historical medical literature indicate that zinc is actually toxic to the nerve receptors in the nose. Zinc was apparently used in the 1930s to try to prevent polio infection, he said.

[lousybassplayer]

BREAKING STORY: Scientists vanely attempt to repeal the universal laws of thermal dynamics! Entropy, the progression of all things from order to chaos can possibly be averted by not using zinc, eating meat or smoking. In fact, if the FDA keeps at it for another few months we will likely figure out how to acheive immortality.

IN the meantime, life is a terminal condition, and all the functions of it will break down, in no particular order. Until the FDA reaches it's goal of a couple trillion dollars of research grants, it will likely remain so.

[bongomania]

^^^ Did you have anything worthwhile to contribute, or just random meaningless spite?

[Ericman197]

Originally Posted by lousybassplayer

BREAKING STORY: Scientists vanely attempt to repeal the universal laws of thermal dynamics! Entropy, the progression of all things from order to chaos can possibly be averted by not using zinc, eating meat or smoking. In fact, if the FDA keeps at it for another few months we will likely figure out how to acheive immortality.

IN the meantime, life is a terminal condition, and all the functions of it will break down, in no particular order. Until the FDA reaches it's goal of a couple trillion dollars of research grants, it will likely remain so.

This article isn't about the FDA impinging on our freedom to choose what goes into our bodies.

This article is about homeo/naturopathic/whatever products that:

- Do NOT work (other than placebo affect)
- BYPASS the normal testing criteria that all other products go through
and
- are occasionally UNSAFE

The fact of the matter is that none of these high vitamin C, high Zinc, or other supplements do anything to help a cold. There's no science behind it, nor is there any real evidence other than small, uncontrolled studies produced BY the manufacturer (or indirectly, through a company owned by the manufacturer).

It's a problem not only because they make false medical claims, but because these products are sometimes harmful - which is only found out later, because they aren't thoroughly tested. I don't have a problem with you or anyone else taking vitamin/mineral/herbal supplements if you believe it will help your cold, arthritis, depression, or whatever. You have to do what you believe is right, based on the facts given to you, your belief system, etc. But I have a real problem with manufacturers that might put something in those supplements without appropriate testing/warning. It's one thing to buy zinc, it's another to buy zinc + ??? + !!!.

If ZiCam contains some sort of chemical that is causing anosmia, and doesn't even contain a warning on the package, it needs to be removed from stores until it can be proven safe. Anosmia, whether temporary or permanent, is not something that is likely to completely ruin lives. But I think those people who lost their sense of smell are unhappy about it, and it probably will affect their quality of life if they do not regain it. It's not just an issue of tough luck, these people weren't warned that it could happen. If I had a nasal spray that had a X% chance of damaging my sense of smell, I wouldn't use it just for a cold.

To give another example of OTC homeopathic medications with serious consequences:

http://www.medpagetoday.com/ProductA...criptions/8816

19 people died due to allergic reactions, because the product contained untested, unsafe ingredients that they were NOT warned were contained in the product.

Unfortunately, these same sorts of adverse reactions are found in all manner of products: name brand prescription drugs, generic drugs, illegal drugs, food products, toys, makeup etc. It is only reasonable to require that there be measures in place to ensure these products are safe*. It's not an issue of an authoritarian government trying to tell everyone what to put in their bodies. There really are corporations out there that would put untested, potentially dangerous chemicals in every day products. While I am not exactly thrilled that the FDA has so much control over what I do, it is important because if not for that control, there is a real risk that products you or I buy could be tainted with lead, for example.

*Of course this is more difficult with illegal drugs, but occasionally the DEA will find certain drugs to be 'laced,' and will report this information to hospitals. For example, MPTP, an ingredient sometimes found in heroin and other street opiates, was found to cause Parkinson's. In another example, in the past few years the DEA has been intercepting very large amounts of cocaine laced with levamisole, a deworming agent for farm animals that can cause life threatening damage to the immune system (why anyone would put an expensive, veterinary medication in cocaine I have absolutely no idea, but the reaction has been reported at several hospitals).

[superjesus]

I quite enjoyed the spite.

[dj150888]

Originally Posted by Ericman197

(why anyone would put an expensive, veterinary medication in cocaine I have absolutely no idea, but the reaction has been reported at several hospitals).

I'm not a tinfoil hat wearing conspiracy theorist, but I reckon a HELL of a lot of that is fallacies pushed into the mass media to scare people away from using illegal drugs. QUite simply put, drug dealers want to make money. Its not good business sense to cut your drugs with something more expensive or to kill your customers. It just doesn't add up.

[lousybassplayer]

Thank you superjesus, I enjoyed rattling on. My meaningful contribution is this. I doubted the usefulness of that particular product anyway. It hardly surprises me that aome believe it may be harmful, look at the number of these silly herbal meds and such that are later found to be at the very least useless and at the worst dangerous to use. It is good to see that the FDA has at least begun looking into a number of such products, but by simply stating that the product is not intended to diagnose or treat disease puts these snake oil salesmen in the clear. The point of my spite is also that people need to think that stuff through on their own. No one forces any product, safe or otherwise, on anyone.

And if my spiteful rant bothers you, I apologize. My sleep will be even more bothered between the guilt and the zicam induced insomnia. I didn't realize I had broken any rules.

[daystcity]

I just realized with the last post that your name was superjesus. Wow, that is quite awesome indeed. A family friend was taking zicam recently, kind of scary!

[Ericman197]

Originally Posted by dj150888

I'm not a tinfoil hat wearing conspiracy theorist, but I reckon a HELL of a lot of that is fallacies pushed into the mass media to scare people away from using illegal drugs. QUite simply put, drug dealers want to make money. Its not good business sense to cut your drugs with something more expensive or to kill your customers. It just doesn't add up.

In the case of cocaine, I don't know anyone who has suffered from levamisole, and I agree that it doesn't make sense. I can't really come up with any reason for using it, I've only just heard that it happens. As far as the reaction I've heard about (agranulocytosis), it is possible that it is unrelated to levamisole.

The MPTP thing was real though, and it's largely because of MPTP-laced opiates that we have a much better understanding of Parkinson's. It's a sort of by product or side product of synthetic opiate production that kills the same cells as are involved in Parkinson's. As far as I know, it's very unlikely to find it these days in street heroin/opiates, but at a few points in time it was going around.

It is unfortunate that as you alluded to, regulatory agencies, FOX news, etc. all have their interests. It wouldn't be a bad idea to have some agencies testing drugs to make sure they're not laced with rat poison or whatever, and to some extent the DEA and hospitals do this. But people don't always believe them when every month or so there's a sensationalist special: "Are your kids smoking marijuana laced with arsenic? Find out at 11!" Fortunately, I believe most people in health care and law enforcement have at least some idea of what's really going on, and are thus able to deal with these problems when they come up.

[coreyfyfe]

Originally Posted by lousybassplayer

IN the meantime, life is a terminal condition, and all the functions of it will break down, in no particular order. Until the FDA reaches it's goal of a couple trillion dollars of research grants, it will likely remain so.

The FDA is a regulatory organization which reviews current research to determine whether or not food, drugs, biologics, and medical devices are safe for the community and provide a big enough advantage over current therapies to warrant introducing them to the market. The only actual research the FDA funds is limited toxicology/MOA studies that are independent of drug development.

Originally Posted by lousybassplayer

My meaningful contribution is this. I doubted the usefulness of that particular product anyway.... It is good to see that the FDA has at least begun looking into a number of such products, but by simply stating that the product is not intended to diagnose or treat disease puts these snake oil salesmen in the clear.

My point is that this is a huge waste of money. The FDA does not regulate herbal supplements and homepathic remedies such as this until there are complains because it would be a complete waste of time to put these products through the INDA/clinical trial ringer. The easiest way to regulate these types of products is to ensure that they're using a combination of relatively harmless ingredients and monitor marketing claims while requiring the label to state that the product is not intended to treat disease.

Although, I'll give it to you that if the FDA did start requiring efficacy studies for these types of products it would be a big deterrent to the introduction of new products to the market.

[edmidlifecrisis]

Hi guys

I was a scientific reviewer at FDA for five years in the veterinary division. The DSHEA act REMOVED from FDA jurisdiction many supplements. The supplements industry bought and paid for Congress to pass this law in the mid 1990's that exempted supplements from having to meet the standard for approval that conventional drug products have to go through (including purity/potency testing). The disclaimer is their ticket out of jail. So many products have blatant therapeutic claims (I see them on TV all the time) for treatment/prevention of disease and then they flash that disclaimer at the bottom, it's galling to see because they ARE intending to treat or prevent disease and saying that they aren't at the bottom is nonsense. The Food Drug and Cosmetic Act defines drugs as substances intended to treat/prevent/mitigate disease of animals or man, but the act was carved up to give a free pass to supplements makers. The FDA was forced into this by legislation. I always knew there would be problems and there are regularly, but don't blame FDA for this one (they can be blamed for other stuff, but not this) as their hands are tied by the laws.

The FDA can only act retroactively and not proactively to supplements, by showing that there are problems with a particular product and THEN acting against the maker. So, the way the laws read now, there have to be people die or have big health problems shown to relate to a particular product in order for the FDA to take action. Not a very good situation, in my opinion.

FDA has a lot of problems and gets a lot of bad press, but they do a lot of good too. That stuff rarely makes the media, however, it's not sensational enough. (I don't work there anymore, in case anyone is asking).

[hbarcat]

I can think of a lot of advantages to permanently losing the sense of smell. I say they should be allowed to sell the product for that specific purpose.

[hbarcat]

Originally Posted by dj150888

I'm not a tinfoil hat wearing conspiracy theorist, but . . .

You know that when a sentence starts out with these words, what follows is sure to be interesting.

[coreyfyfe]

Originally Posted by hbarcat

I can think of a lot of advantages to permanently losing the sense of smell. I say they should be allowed to sell the product for that specific purpose.

That's our drummer haha, he's never had a sense of smell. He let's loose all the time in our practice space and kills the rest of us but he just sits there and enjoys it.

[dj150888]

Originally Posted by hbarcat

You know that when a sentence starts out with these words, what follows is sure to be interesting.

And was it?

[Brick Top]

This scares the crap outta me. I just used the nose swabs for the first time a couple of weeks ago on a endorsement from one of my customers. I wasn't religious about using the swabs as much as the directions told me too. But I did have a loss of smell and taste for almost two weeks. Of course...having a cold can be contributed to this condition. I stopped using the swabs over a week ago....and my smell and taste are not back 100%...but at least I have some of these senses.

The rest is going in the trash.

Cheers,
BT

[hbarcat]

Originally Posted by dj150888

And was it?

Oh, yes.


That post delivered!

[hbarcat]

Let me try one:


I'm not a tinfoil hat wearing conspiracy theorist, but . . .

. . . ZiCam is a major sponsor of Rush Limbaugh and Rush has been very critical of "Big Government" in the last few months. Now the FDA is closing down ZiCam . . . you connect the dots!










P.S. The above is meant to be taken as a light-hearted joke and is not an attempt to be serious or in any way invite this thread to become political.

[dj150888]

Originally Posted by hbarcat

Let me try one:


I'm not a tinfoil hat wearing conspiracy theorist, but . . .

. . . ZiCam is a major sponsor of Rush Limbaugh and Rush has been very critical of "Big Government" in the last few months. Now the FDA is closing down ZiCam . . . you connect the dots!










P.S. The above is meant to be taken as a light-hearted joke and is not an attempt to be serious or in any way invite this thread to become political.

By GOD, its all starting to make sense now!

[hbarcat]

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