ZICAM - FDA warning

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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 Zicam

products since 1999.

" Loss of the sense of smell is potentially life threatening and may be

permanent, " said Dr. Lee. " People without the sense of smell may not be

able to detect life dangerous situations, such as gas leaks or something burning

in the house. "

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 manufacturer Matrixx Initiatives 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 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.

Matrixx Initiatives is facing multiple lawsuits over the product, 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. "

Representatives from the sdale, Ariz.-based company, which saw its stock

price plunge to a 52-week low after the FDA announcement, did not immediately

return calls for comment Tuesday.

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.