Zicam Didn't Share 800 Reports Of Smell Loss With The FDA
The Wall Street Journal says that Matrixx, the manufacturer of the allegedly smell-destroying cold remedy Zicam, is defending their product, but also admits that they didn't share 800 reports of smell loss with the FDA. Despite this, they described the FDA's warning about Zicam as a "complete surprise."
From the WSJ:
"We are hopeful that if we can tell our story to the FDA, that maybe we can get them to change their mind," Matrixx Acting President and Chief Operating Officer William Hemelt said. He claimed that the safety concerns are "erroneous" and said that the agency made no effort to communicate its concerns with the company prior to this week.
The product has apparently been the target of many consumer lawsuits.
"Plaintiffs will still have to prove that Zicam cold remedy caused their loss of smell," Hemelt told the WSJ. The company settled 300 smell-related lawsuits in 2006, but the company president maintained that studies show that Zicam doesn't reach the area of the nose responsible for smell. He then admitted that the company didn't share 800 reports of smell loss with the FDA.
Hemelt said the company didn't believe it was required to share the information and acted on the advice of company lawyers.
UPDATE: Matrixx Defends Zicam Pdts Included In FDA Warning [WSJ]
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Comments:
Not required to share? I can understand a few odd cases, where the loss being caused by the product is questionable....but 800? That's ridiculous.
I have known about this for years. I am surprised that the FDA is just now warning us?
Just because you can't SPRAY Zicam all the way to the back of your nose doesn't mean that the zinc doesn't LEACH (or otherwise get transported) to that area. It should go without saying, but nerve tissue is sensitive to small amounts of ANYTHING... and the human sense of smell is the strongest sense.
Legal Secretary: Oh! Here is the memo I was going to forward to the FDA!
"Awww. We really DO have to report all the adverse reactions? Well, phooey. But it's okay if our lawyers said we didn't have to. Right? Right?"
Regardless of what happens here, Matrixx is sunk. Even if the can get their products back on shelves, the bad PR coming with this whole scare is going to dissuade people form using Zicam for a long while.
A quick reading of this leads one to come to the conclusion that the FDA's actions was a surprise to Matrixx because they thought they'd been more successful at keeping information regarding this pesky loss of smell problem from the agency.
Tad misleading with the "surprise" remark. Let's look at the press release.
"Commenting on the FDA action, Hemelt continued, "We were surprised that the FDA decided to take this action without notifying us first, given our cooperative relationship with the FDA since we launched our first product in 1999."
[www.zicam.com]
Also, "As with any drug, unwanted side effects may occur in susceptible persons. Please let us know if you experience any unexpected reactions. If you have an allergy or sensitivity to any ingredient in Zicam Allergy Relief Swabs, please consult your doctor before use."
So, it's possible it wasn't a case of neglect.
*Waits for someone to call him a corporate apologist*
@MooseOfReason: except you've left the part out where matrixx has avoided FDA testing by claiming their products are Homeopathic. Thereby leaving all the responisblity of warning consumers of side effects on Matrixx which they failed at.
@Cogito Ergo Bibo: Well if we learned anything from the previous administration, it's that as long as a lawyer can invent some contorted legal agreement that completely goes against the spirit (and word) of the laws that says its OK, you can do anything you want.
@logicalnoise:
"given our cooperative relationship with the FDA since we launched our first product in 1999"
Except for the 800 cases of a fairly severe side effect that they didn't bother telling the FDA about?
Lying (lies of omissiont) != cooperating
@Featherstonehaugh: That's what really gets me. We've know for YEARS that Zicam causes loss of smell. I always assumed that it happened rarely enough that the FDA considered the risk acceptable, but now it's suddenly 'OH MY GOD WE HAD NO IDEA'?
Channel 7 CBS in Denver has been on the warpath about this issue for at least three years, if not longer. Apparently there a many Coloradoans that have lost their entire sense of smell after using Zicam products.
Losing one's sense of smell is a terrible affliction, since the sense of taste is mostly smell. Those afflicted have said that everything they eat is like eating tasteless muss, cardboard, etc. Some have been suicidal.
That this FDA judgment comes after Obama's election is no surprise to me. Bush eviscerated the FDA, making entirely useless as the guardian of foods and drugs. Obama wants new consumer protection bureaucracies: all he needs to do is restore the FDA, the FTC, and the SEC to the bulldogs with teeth that we all expect from our consumer protection agencies.
@Secret Agent Man: Not only that. I used to work for a biotech company. It takes years and years of research and development to come up with a final product. If that product doesn't turn out the company is at a LARGE risk for bankruptcy (I'm looking at you MedImmune and that flooey of a nasal spray you had a few years back). Even if they are able to get the funding to go back and tweak it so that these side effects are gone, like you said, there is no way anyone is buying a nasal spray from them. Countless dollars and hours now gone. All because of carelessness.
This actually bums me out a bit. Zicam's Extreme Congestion Relief Nasal Gel works better than anything else when you've got a cold to clear out your nasal passages so you can breathe and sleep. It's great for allergies too. I always keep some in my bag in the spring.
Not anymore. Time to hunt for a new product.
@pezstar: I recommend you try to find something that is not a scam or a placebo this time around. Since Zicam caused trouble, it therefore was not just WATER and was not homeopathy per say, but it tried to pass off as "homeopathy". Homeopathy is just overpriced water, and therefore it is a fraud.
Try some nasonex or flonase or such. You know... proven nasal sprays...
What is it going to take to have "nutritional supplements" and "alternative" medicine regulated by the FDA? Whether it's chiropractors claiming to cure ear infections, or homeopaths hawking magic water, or colon cleansers that fill people full of clay so they can shit voluminously, snake oil is snake oil. It's not harmless and it needs to pass the same rigorous, scientific tests that so-called conventional medicine does. You know what you call alternative medicine that been tested and found to be effective? They call it medicine.
this story makes me like the biotech company i work for even more. and i know i can sleep at night knowing that my job is to take down reported side effects, report them accurately and quickly, and get them to the drug safety team to send to the FDA on a regular and frequent basis.
and then when i talk to our patients i tell them all about the side effects. i volunteer info about the side effects. it's part of the job.
which is probably part of why i still have a job and my company hasn't yet [is this desk real wood? knock!] been shut down or severely fined by the FDA.
Just curious, how are other ways you can lose your sense of smell? Other than a firecracker up the nose and a love of MacGyver, that is.
@Gawd Dammit: Proven nasal sprays that have links to losing sight.
Yowza, can't a brotha get any kind of break without trading in one of the five outward wits?
@pezstar:
Try Simply Saline Allergy forumla. It's just a saline solution, but it work wonders with my allergies and other sinus issues.
While I can certainly appreciate your efforts to wave your e-peen around today, perhaps it would behoove you to actually be familiar with a product before you decide to act self righteously indignant toward those who purchase it.
Zicam's cold prevention medications are marketed as homeopathic.
Zicam's symptom relief nasal gels are entirely different products. The Extreme Congestion Relief product I mentioned above is neither homeopathic or placebo. It's an actual nasal spray containing actual medication that was made to *gasp* clear nasal congestion.
You lose.
@Quaoar: Are you saying that the FDA hasn't published any public health advisories during all of Bush's term? That's a bit of a reach, don't you think?
And the poor zicam user can't even "smell a rat". why not just ban the use of zinc in all these products, as well as lead? Like the denture glue.
So the story crosses from "Ha-Ha. Stoopid customers too lame to read directions" to "Nefarious Big Pharm company lies during approval process to hide life-crippling side-effects". Quelle surprise.
Cynics are justified, lawyers rejoice and poor, poor consumers get the shaft.
Whatever monetary damages result (and, oh WILL there be blood. Yes there will be blood!), I'd like to see all executives to be forced to inhale their product until their sense of taste is also permanently ruined.
@MooseOfReason: What kind of monster would suggest that companies that sell products that could permanently destroy their sense of taste (short of losing my weenie, I couldn't imagine a worse fate) don't have to be forthwith about this?
Seriously. What kind of monster would be an apologist for this behavior?
Jeezus. Tell you what: sample the stuff and get back to us on how "minor" this is. OK?
@Featherstonehaugh: I lost my sense of taste for about a week when taking Zicam's oral mist in February 2008 and didn't realize I had the recourse to complain to the FDA. Instead, I used Google and it showed me that there was a pending class-action lawsuit against the company. I ended up blogging about it instead.
I'm in agreement with you. Their claim that it's a "complete surprise" spells BS from miles away.
@Applekid: A severe blow to the head is one of the most common causes of anosmia. The neurons responsible for conducting the sense of smell pass through bone at the top of your nasal passage into the brain. Blunt force to the head can jostle your brain enough to shear those neurons apart quite easily. I am pretty sure it is a fairly common side effect of car wrecks.
@Secret Agent Man: small price to pay for getting rid of the sniffles for a couple of days. who wants to smell the coffee brewing anyway?
@Winteridge2: Poligrip. Pollident, all those false teeth products. The zinc in them allegedly causes numbness in the feet. Go figure.
@Quaoar: Useless factoid of the day: Stevie Wonder can neither smell or see.
IIRC, he was a passenger in a car that rear-ended a truck in front of them. A 2x4 came through the windshield and hit Stevie in the head, causing permanent loss of smell.
Is it too late to start using Zicam and be a part of the inevitable lawsuits?
Oh it is? I'll see myself out...
@pezstar:
When I have a cold, I guzzle Nyquil before I go to bed. It knocks me out so I don't notice I can't breathe.
@pezstar: Then shouldn't it be classified as a drug and therefore subject to FDA regulation?
The way they got around that with their other products *was* claiming they were homeopathic...
As long as the FDA lets companies do the research and tell the FDA what is good or bad, well, the agency will be a dark hole for taxpayer money. Besides, the FDA over the last decade has become the protector of powerful interests and companies while belittling and ignoring the weak or those hurt by the products/services made by these industries.
Health Canada recently warned its residents about the dangers of these Zicam products. Hearing that Matrixx held back the 800 reports is not surprising: [www.newsinferno.com]
@Applekid: My father-in-law lost his sense of smell after many years of working at a chemical factory. I would be pretty mad about that, but he doesn't seem too concerned.
... and to think no one thought it was a bad thing when the president and Congress took away the FDA's oversight of dietary supplements and homeopathic "remedies." Probably the reason Matrixx's lawyers told them not to tell the FDA, was because they knew the FDA was not legally entitled to that information.
Note that other products such as "Airborne" had to be targeted by other federal agencies (in that case, the FTC). The FDA had zero jurisdiction and could do absolutely nothing to stop them from selling something that doesn't come anywhere near to doing what it claims to do.
Does anyone now doubt that the FDA needs to be given regulatory control over the supplement & homeopathy businesses? (Hmm, I'd have thought people dying after taking ephedra would have taught the country that lesson ... but I was wrong. I'm probably wrong now. Oh well.)
Ummmm...okay, time for criminal indictments here...
Regulation is BACK! Snort it ZICAM.
MISSION
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Looks better
@WhoAsked You:
I think FDA is the one who should be indicted.
We have known for YEARS that Zicam can cause loss of smell. Why did the FDA wait so long to warn the general public? Sounds like they dropped the ball and now they're trying to cover their ass.
Off with their noses!
I can tell you that when I have taken their disolvign tablets in the past they kill and/or severely limit my taste buds for hours.
Yeah, because corperate lawyers are the most trustworthy of people when it comes to people who arent their employers.