WARNING about Zicam nasal spray and swabs

[pacificvibes]

There is a new warning about the popular drug Zicam

http://news.yahoo.com/s/ap/20090616/...ne_fda_warning



FDA says Zicam nasal spray can cause loss of smell

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.

[DetroitSportsFan]

This is why I don't take any kind of drugs whatsoever unless absolutely necessary.

[silversnake]

thanks for the heads up. I have used this in the past.

[SleeperAgent]

Loss of smell is called "Anosmia" (sp?)

Odd that said information wasn't in there at all. Learned it from Scrubs.

[Porkchop Express]

This side effect was known about years ago, I'm shocked it took the FDA this long.

[Fors*]

I think this shows just how "strong" and "shady" the pharmaceutical companies can be in getting their product out there for the almighty $$$$, in spite of their customer's health. I only take aspirin for a headache, and only when it is unbearable (which is very rare.) Geez.

[MaCruz]

My coworker uses a nasual spray but not this brand. I just forward the link to him to make sure.

[bongzilla]

That would be a drag not to be able to smell, no roses, no frying bacon.

[Marquoz]

Originally Posted by bongzilla

That would be a drag not to be able to smell, no roses, no frying bacon.

No B.O., no decaying food in "friends" houses ... it's got some advantages.

[tlmaclennan]

Bummer, this stuff really helps me avoid severe colds!

[DrinkMore]

I read about this a few weeks ago when it was still "unknown" and refuted by the company selling the stuff. Now it looks like it's official.

I have used this stuff before. I used the spray a few times some years ago. I switched to the tablets and have used those instead because I swore this stuff was messing with my sense of smell. I guess that has been confirmed now. My sense of smell has been off for a while. Not what it used to be but it is coming back slowly. It was pretty weird because my family would say, you can't smell that - and I would be like - no. They were shocked because I could smell pretty much anything.

To think I have avoided recreational drugs to keep me safe, yet the stuff that is suppose to be safe is screwing me up worse? Go figure.

The stuff works by the way. Not sure if the tablets are included in the FDA notice or not.

[mikejet]

Since it is detrimental to your sense of smell would it also be bad for your sense of taste as the two go somewhat hand in hand?

[DrinkMore]

Originally Posted by mikejet

Since it is detrimental to your sense of smell would it also be bad for your sense of taste as the two go somewhat hand in hand?

I think you might be right.

Looks like I will not be using this stuff anymore.

[Porkchop Express]

Originally Posted by DrinkMore

I think you might be right.

Looks like I will not be using this stuff anymore.

Zinc will not take away your sense of taste. If you really thought zicam helped you, just use a zinc lozenge.

[brettallica]

Originally Posted by DetroitSportsFan

This is why I don't take any kind of drugs whatsoever unless absolutely necessary.

That's my philosophy. I don't even take Tylenol or anything like that. My drug of choice is the caffeine in my coffee.

It really sucks that this product is harmful to one's health when it's supposed to alleviate issues, though. I've personally never even heard of Zicam before, but that's possibly due to the fact that I never seek these medications to begin with. Hopefully those who rely on it can find an adequate substitute.

[aramis109]

Originally Posted by Porkchop Express

Zinc will not take away your sense of taste. If you really thought zicam helped you, just use a zinc lozenge.

It may, or it may not, but losing your sense of smell DOES take away some of your sense of taste. Smell and taste are very closely linked together. Food can seem very bland without a sense of smell.