FDA: Nasal Spray Can Cause Loss Of Smell
Consumers Advised To Stop Using Zicam Cold Remedy Nasal Gel And Related Products
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Play CBS Video Video Concerns Over Zicam Dr. Jennifer Ashton spoke with Harry Smith about reports of loss of taste and smell attributed to over-the-counter Zicam cold medication.
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(AP / CBS)
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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."
CBS News medical correspondent Dr. Jennifer Ashton said Wednesday on The Early Show people can lose their sense of smell temporarily if they have a cold, but added it's "concerning" that people are attributing losing their sense of smell to using Zicam.
She told Early Show co-anchor Harry Smith she would tell her patients not to put anything up their nose.
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. The FDA never fully regulated these products, because they were considered homeopathic treatments, reports CBS Radio News correspondent Barry Bagnato.
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.
© MMIX, CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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See all 25 CommentsI wonder what the markup is on zinc gluconate as it goes into Zicam?
There are a lot of fools out there that think just because something is labelled "alternative" it is safe.
Wrong.
nose. No one seems to do anything in moderation any more. "If one squirt
works, then why not a gallon? I work in a hospital and see people do the
same thing with other "mist/inhalant" products. Do we need more laws to
protect idiot jerks?!
Our whole family uses Zicam for years. We have had no problems with it. We like it because it is natural and nonaddictive. Please do not take this off the market because of 130 reports that say different!
The federal government should consider taking a more pro-active approach to the over the counter products as it is doing with tobacco.
Many OTC products, having no basis for the intended uses are really just gouging the public with snake oil cures.
In today's world, with physician costs at a premium, recognition of the medical value of a product would certainly benefit society.
The government under the Bush administration had basically a 'hands off approach' to businesses and their advertising. With the internet as a backdrop, perhaps the Obama administration could start to rectify the sins of free enterprise system gone amuck.
(Just one more to-do item that the Obama administration can put on its plate).
Another Bush capitulation to industry. Really, who cares about the American public when there is money to be made, right Republicans?
Zicam is a great help to me. It stops cold germs from multiplying after exposure to a virus. I have been using it for years with no problems. I would hate to see this product removed from the market because a few people have had problems.
Why does the MINORITY (people who have had problems with Zicam) always seem to get their way?
If they had told the truth at the beginning, the industry could have learned how to screen for this gene in people and told us if we could safely use Zicam or not. They didn't, so let the lawsuits fly...
Utter BS. Been using it for years with no problem. They want to pull this because of 130 REPORTS? Why, so they can replace it with ObamaCare?
Count yourself lucky, My sense of smell is gone, Zicam and Afrin are to blame. some it gets and some it don't. Obama has nothing to do with this, I lost it before he got in office. Find some other lie to spread about him..
Why does the MINORITY (people who have had problems with Zicam) always seem to get their way?
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