FDA: Nasal Spray Can Cause Loss Of Smell

Consumers Advised To Stop Using Zicam Cold Remedy Nasal Gel And Related Products

(CBS/AP)  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."

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.

[Lynn816]

In Feb. 2009 I used Afrin nasal spray twice and lost my sense of taste and smell. It's now October 2009 and I still haven't regained either sense. It's terribly frustrating and inconvenient. The plus side is I have lost weight since I only eat because I get hungry. I'm considering joing a class-action lawsuit. Any information on this?

[oOSunshine81]

I also have been using Zicam for years, following the instructions to a tee and I personally believe I have a great sense of smell. I have a feeling people who have lost there sense of smell were inhaling the gel. So sad this product is being taken off the shelf, it works!!!

[blueskies11-2009]

I am so bummed. My husband and I have been successfully using it 7 or 8 years. This stuff really works! We haven't had one single cold/flu virus since. We always used the swabs. The directions say don't snort it and also don't use it for a prolonged period of time. We followed the directions. No problem with our sense of smell. Now the FDA will make you go to a doctor, get a prescription and pay a fortune for the stuff. Today I am going around to see if I can find some places that haven't taken it off the shelves yet and buy it up. Hope I am not too late.

[lj012]

Obama the omnipotent reaches out and eliminates one of Rush's supporters.

[nolongersick]

I know of a prevention method that's drug-free. It is a great program called Germy Wormy Germ Smart that teaches kids to understand how germs spread and how to NOT spread germs. My daughter learned it at school. It was so much fun for her, and it was amazing how quickly the kids learned healthier hygiene habits!

[johnbrown8888]

Homeopathic medicines, herbal medicines and nutraceuticals undergo no testing whatsoever--zero--so many snake oil salesmen out there are happy to sell you some cheap meds for big prices.

I 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.

[gdod25]

When will you learn? Do you really thing there is a differance between parties? BlackBush is following the plan same as George.

Maybe it wouldn't be a problem if you didn't squirt a large amount up your
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?!

[cyhawk]

cyhawk
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!

[cattlekate1]

So who is protecting us from this OTC scam, as well as the late-night infomercials we see? Shouldn't there be safeguards before the advertisements hit the airwaves?