FDA says Zicam nasal spray can cause loss of smell
[Pages:2]FDA says Zicam nasal spray can cause loss
of smell
16 June 2009
(AP) -- Consumers should stop using Zicam Cold because of the product's safety issues, she added.
Remedy nasal gel and related products because
they can permanently damage the sense of smell, Matrixx Initiatives is facing multiple lawsuits over
federal health regulators said Tuesday.
the product, but says on its Web site: "No plaintiff
has ever won a court case, because there is no
The over-the-counter products contain zinc, an known causal link between the use of Zicam Cold
ingredient scientists say may damage nerves in the Remedy nasal gel and impairment of smell."
nose needed for smell. The other products affected
by the Food and Drug Administration's
Representatives from the Scottsdale, Ariz.-based
announcement are adult and kid-size Zicam Cold company, which saw its stock price plunge to a
Remedy Nasal Swabs.
52-week low after the FDA announcement, did not
immediately return calls for comment Tuesday.
The FDA says about 130 consumers have reported
a loss of smell after using Zicam products since Health officials said they have asked Matrixx
1999.
executives to turn over more than 800 consumer
complaints concerning lost smell that the company
"Loss of the sense of smell is potentially life
has on file. A 2007 law began requiring
threatening and may be permanent," said Dr.
manufacturers to report such problems, but FDA
Charles Lee. "People without the sense of smell regulators declined to say Tuesday whether the
may not be able to detect life dangerous situations, company broke the law.
such as gas leaks or something burning in the
house."
The 130 reports received by the FDA came entirely
from physicians and patients, not the
The FDA said Zicam Cold Remedy was never
manufacturer.
formally approved because it is part of a small
group of remedies that are not required to undergo Regulators said the relatively small number of
federal review before launching. Known as
complaints accounted for the agency's lengthy
homeopathic products, the formulations often
investigation.
contain herbs, minerals and flowers.
"FDA doesn't take action against drug products
A warning letter issued to manufacturer Matrixx without evaluating all of the circumstances
Initiatives on Tuesday asked the company to stop surrounding the issues with the product," Lee said.
marketing its zinc-based products, but the agency
did not issue a formal recall. Instead, regulators Shares of Matrixx Initiatives Inc. plummeted
said Matrixx would have to submit safety and
$10.71, or 55.7 percent, to $8.53 in afternoon
effectiveness data on the drug.
trading.
"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.
?2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
The agency is requiring formal approval now
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