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Colds Win! Zicam Pulled from Shelves

Posted by madeline holler on June 17th, 2009 at 3:58 pm

zicam Colds Win! Zicam Pulled from ShelvesThe FDA issued a warning against Zicam, saying the over-the-counter treatment has caused 130 people to lose some of all of their sense of smell. The agency called for the product to be pulled from shelves until its maker, Matrixx, can show that the zinc-based gel cures colds without the damaging side effect.

Initially, Zicam didn’t have to be FDA approved for sale since if falls into the category of homeopathic treatments. But the reported smelling-loss cases allow for regulators to intervene and require a clinical investigation showing Zicam is safe.

Zicam is one of those products with a huge following — people swear by it. So I have to wonder … if 130 cases of smelling loss is all that remarkable. Also, of those 130 cases, how many overused the stuff, which requires you to smear zinc-laden gell with a swab inside your nose.

Let’s hear from you: about time they pulled this crap off the market? Or are you heading to Walgreens to pick up every last box of the stuff — just in case?

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 Colds Win! Zicam Pulled from Shelves

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14 Comments

[...] Colds Win! Zicam Pulled from Shelves [...]

The Story Behind Some Awkward Family Photos | Strollerderby commented on Jun 17 09 at 5:18 pm

[...] Colds Win! Zicam Pulled from Shelves [...]

They Say: Missing Girls? Blame Early Weaning | Strollerderby commented on Jun 23 09 at 1:13 pm

This case just highlights what a problem it is to have lower regulations for homeopathic remedies. (If this were a supplement, like a lot of “natural” remedies are, there would be no oversight at all.)

If Zicam were classified as a standard, OTC drug, it probably would never have been approved.

This is why I cringe when people say “natural” remedies are safer. They often have things in them that are not natural, and are much less safe than standard medication because of the lack of regulation.

You really think that 130 cases of smelling loss is not that remarkable? Standard drugs are recalled for much less than this.

Laure commented on Jun 17 09 at 4:13 pm

Oh, and there is another issue you do not mention. These 130 cases came directly from consumers to the FDA. None of them came from the company. However, the company has over 800 complaints that they never turned over to the FDA. To be fair, I don’t understand if this is a regulatory violation for homeopathic medicine. (It certainly is for standard medication!) However, ethically they should be responsible for these complaints.

Laure commented on Jun 17 09 at 4:16 pm

I used the liquid Zicam once–did you read that? I said ONCE–and it made my gums completely numb and my mouth felt weird for about 24 hours. I decided then to never touch the stuff again, and I cringe when I hear about friends using it. It’s just creepy to me.

Barb commented on Jun 17 09 at 4:42 pm

Really, homeopathic medicines are a modern version of snake oil. If people want to try these things out on themselves, I can’t stop them. However, people should never, ever give homeopathic (or even herbal) remedies to children. Think about it – would you give a drug that had no testing behind it to a child?

Lisa commented on Jun 17 09 at 5:02 pm

“But its all natural” is what I hear when I express a little concern over a “natural” remedy that I haven’t researched well.
Guess what – so are lead and arsenic.

PlumbLucky commented on Jun 18 09 at 7:58 am

Lisa – what non-homeopathic drugs are you giving your children that you honestly think HAVE been tested on children? Get real!

Jess commented on Jun 18 09 at 12:56 pm

Jess, at least they have been tested. Yes, it is true that it is unethical to conduct a clinical trial on children. But homeopathic and herbal remedies have no barrier to entry into the US market. At least some kind of trial and review has to be conducted with OTC drugs, and once they are on the market they are followed in a very stringent manner.

I used to work on clinical trials, and most people have no idea how much goes into one, and what needs to be proved before a drug or device is released to the market. Compare that to absolutely no regulation. (At least homeopathic remedies are supposed to be followed once on the market. Herbal supplements have to such requirement.)

Lisa commented on Jun 18 09 at 4:02 pm

Dietary supplements (including herbal products) ARE, IN FACT regulated by FDA, ladies. They are not regulated in the same way as drugs, but they *are* regulated. http://www.fda.gov/Food/DietarySupplements/default.htm

There are plenty of criticisms out there about there not being enough regulation, but to say they have “absolutely no regulation” is false. Furthermore, if supplements were to be regulated as drugs, your vitamin C pills and calcium and multivitamins and all that would cost a WHOLE lot more. That’s not a road I want to go down, especially given the track record of pharmaceuticals that are supposedly so tightly regulated.

GP commented on Jun 19 09 at 12:57 pm

GP – although dietary supplements (such as herbal remedies) are technically regulated by the FDA, the regulation consists of almost nothing. There is no requirement to prove safety or efficacy. There is a very high burden of proof on the FDA to show that a product is harmful before they can take action. There is no burden of proof on the supplement maker to prove safety or efficacy.

Homeopathic products are somewhat different. They also do not need to prove safety or efficacy – they only need to be added to a list in the Homeopathic Pharmacopeia, which is done by a non-government body. There is no testing necessary to be added to this list. However, as it is regulated as a homeopathic drug, after the product is on the market the FDA can decide if the product poses a safety risk and can demand evidence.

Traditionally, homeopathic remedies were diluted to such an extent that it was practically a placebo. With Zicam, there are biological levels of zinc, but it was still allowed to be included as a homeopathic remedy.

I don’t have a problem with vitamins as long as they just say “Vitamin C”, or whatever. The issue is when a supplement is allowed to say something like “colds will not last as long” without having to provide any evidence to prove the statement is correct.

Cali Mom commented on Jun 19 09 at 9:56 pm

Cali Mom, FDA does put restrictions on what supplement products can say on their label. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm

Zicam is not a supplement, of course, but a homeopathic remedy.

But, there are alot of misconceptions about supplement regulation resulting from a lack of understanding and tons of bad press. Supplements actually have to adhere to good manufacturing practices (GMPs) stipulated by FDA to ensure quality. Additionally, manufacturers are required to report serious adverse events (AEs) to FDA. These are both fairly new developments in supplement regulation (past 2-3 years). The industry waited quite a while for these regulations to be implemented by FDA, although they were mandated by Congress (at least the GMPs) back in 1994 with the Dietary Supplement Health and Education Act (DSHEA). Responsible industry supported and fought for both of these (GMPs and AE reporting) sets of regulations because they know the vast majority of their products are safe and wanted a level playing field.

GP commented on Jun 19 09 at 10:24 pm

@Barb: Just because you dont “like it” doesnt mean that its a bad product. @Lisa: Your just an idiot.

My opinion: Zinc has been proven to help with cold symptoms. As long as it works the same with the oral treatments I have no issues. I have used the Zicam product only a couple of times but the times that I did use it, I felt it did have an impact on common cold symptoms.

Seaborn commented on Jul 21 09 at 5:35 pm

That sucks. No wonder I couldn’t find it. This product always worked for me. There was only one time that I used it when I started feeling like I was getting a cold, and it stopped my cold symptoms but it made my nose bleed. I still had some left over and I have been using it for the past 48 hours like the box says so I can lessen the severity of this cold I have now, and it has worked wonderfully. I would be bed ridden right now if not for this stuff. I tried the rapid release capsules before the gel swabs and they were awful. The nose swabs were the best ones to stop a cold because that is the source from where they start. Not the throat which is why these throat lozenges are going to flop. If you don’t already have a throat infection, then your sore throat is because of the drainage down your throat from the nose. If you feel like you are catching a cold, you fight it off from the first place to show these symptoms. From the nose! Not the throat! And btw, my nose has not bled since and I still smell the roses just fine.

Casey Chase commented on Nov 22 09 at 12:57 pm

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