FDA says Zicam nasal spray can cause loss of smell

[Dr T]

FDA says Zicam nasal spray can cause loss of smell

By MATTHEW PERRONE

WASHINGTON

Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives' Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

"Loss of the sense of smell is potentially life threatening and may be permanent," said Dr. Charles Lee, of FDA's compliance division. "People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house."

Matrixx defended the safety of its products, but said it may remove them from the market.

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.

A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

"The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval," said Deborah Autor, director of FDA's drug compliance division.

The agency is requiring formal approval now because of the product's safety issues, she added.

"It won't bring my smell back, but at least I feel like there's some justice that's starting to take place," said David Richardson, of Greensboro, N.C., who lost his sense of smell after taking Zicam for a cold in 2005. He said he hopes the product will be formally banned.

Medical records appear to support Richardson's claim that his lost sense of smell was linked to using Zicam.

The global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. The group's members include companies like Nutraceutical International Corp. and Natural Health Supply.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: "No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell."

The company said in a statement Tuesday that the safety of Zicam Cold Remedy is "supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists."

But government scientists say they are unaware of any data supporting Zicam's labeling, which claims the drug reduces cold symptoms, including "sore throat, stuffy nose, sneezing, coughing and congestion."

Matrixx said it will consider withdrawing the products, which accounted for about 40 percent of its $111.6 million in sales last year.

Health officials said they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.

Regulators said the relatively small number of complaints accounted for the agency's lengthy investigation.

"FDA doesn't take action against drug products without evaluating all of the circumstances surrounding the issues with the product," Lee said.

Shares of Matrixx Initiatives Inc. plummeted $13.46, or 70 percent, to $5.78 Tuesday.

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AP National Writer Jeff Donn in Boston contributed to this report.

[Moksha]

This many be of great help to sanitation workers.

[marshac]

This many be of great help to sanitation workers.

I rub a little vics under my nose when messing with the cadavers. The first time I rubbed it IN my nose... wow, what a mistake that was.

Unfortunately I think that this Zicam incident will lead towards the FDA regulating all supplements. Since many of them have legit therapeutic effects, this could potentially be a big loss to many

[Dr T]

My wife puts Vicks on her lips every night. No thank you. I wonder how much this

Litigious country will get out of them. "I can't taste anything now!" they might all say. Hmmm...we'll see.

[Winnie G]

The loss of smell you also lose the gift of tasting,

my grandfather was gassed Mustered gas during WW1 and lost it all. Eating was just something he had to do after that,

PS I worked in a funeral home years a go and Vicks was our friend.

Comes in handing washing out stinky trash cans or Baby's dippers LOL

[Dr T]

Thanks for that image Winn :)

[DigitalShadow]

Unfortunately I think that this Zicam incident will lead towards the FDA regulating all supplements. Since many of them have legit therapeutic effects, this could potentially be a big loss to many

If they have legit therapeutic effects, why not go through the same system that drugs go through to ensure the claim is legit and that the product is not harmful?

[Misshalfway]

i rub a little vics under my nose when messing with the cadavers. The first time i rubbed it in my nose... Wow, what a mistake that was.

Unfortunately i think that this zicam incident will lead towards the fda regulating all supplements. Since many of them have legit therapeutic effects, this could potentially be a big loss to many

This is an outrage!!! I will write a strongly worded letter. (clearing my throat....) "To Whom it May Concern......."

[Hemidakota]

FDA says Zicam nasal spray can cause loss of smell

"The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval," said Deborah Autor, director of FDA's drug compliance division.

The agency is requiring formal approval now because of the product's safety issues, she added.

Perhaps the FDA needs to add Alcoholic beverage to the recall since it does damage neuronal pathways. Hypocrisy rules...

[Dr T]

Hasn't that been tried Hemi?

[prospectmom]

Don't you think consumers need to use common sense and not over use supplements. Most of these cases like this are consumers using more than the advised dose or not following directions like in Hydroxy cut case not drinking at least 8 glasses of water daily..... Common sense people.

[FlaviusHambonius]

I can't imagine not being able to smell all of the wonderful things in life--Flowers, the aroma of food cooking, perfume as a woman passes by.....and then of course my Hai Karate after shave.

To miss the taste of wonderful food would be missing out on a great blessing in life.

[pam]

YOu mean someone actually still wears Hai Karate?

[Kawazu]

If they have legit therapeutic effects, why not go through the same system that drugs go through to ensure the claim is legit and that the product is not harmful?

Hi,

The FDA approval process would cost individual supplement suppliers millions and millions of dollars. Therefore, it is unfeasible.

I do support any third-party organization that would verify the ingredients claimed in non-pharmaceutical supplements. As for their effectiveness, I can research that, independently.

Cheers,

Kawazu

[FlaviusHambonius]

YOu mean someone actually still wears Hai Karate?

Pam,

You wouldn't believe the women that flock around me after I throw some of that stuff on--that old comercial wasn't lying.

You do believe me don't you?

[pam]

*sniffs* Nope

[DigitalShadow]

The FDA approval process would cost individual supplement suppliers millions and millions of dollars. Therefore, it is unfeasible.

I do support any third-party organization that would verify the ingredients claimed in non-pharmaceutical supplements. As for their effectiveness, I can research that, independently.

Maybe there should be an easier process for supplements that make no guarantees that they do anything useful, but the FDA has examined them to make sure that they are not harmful when used as directed. The supplement industry is HUGE, but I think most of it just preys on gullible consumers who get a mild placebo effect while they throw their money down the toilet.

I don't necessarily have a problem with that (business is all about separating gullible people from their money), but I also have a hard time feeling sorry for most supplement suppliers when they get called out for being dangerous and/or making fraudulent claims.

Edited June 19, 2009 by DigitalShadow

[Dr T]

Good thought DS