Zicam may damage sense of smell - FDA

Shares of manufacturer Matrixx Initiatives plummet more than 55% after government warns consumers to discontinue use. Stock is halted.

EMAIL  |   PRINT  |   SHARE  |   RSS
 
google my aol my msn my yahoo! netvibes
Paste this link into your favorite RSS desktop reader
See all CNNMoney.com RSS FEEDS (close)
By Julianne Pepitone, CNNMoney.com contributing writer

matrixx_weekly.mkw.gif
When will the government come up with a plan to reform health care?
  • By the end of the year
  • By the end of Obama's term
  • It won't happen

NEW YORK (CNNMoney.com) -- Consumers should discontinue use of Zicam Cold Remedy nasal gel and related products because they can can permanently damage users' sense of smell, the government said Tuesday.

In a press release, the U.S. Food and Drug Administration advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued "kids size" swabs.

The FDA warned the three products could cause anosmia, the loss of sense of smell, which "may be long-lasting or permanent."

After that news was released, shares of Scottsdale, Ariz.-based Zicam manufacturer Matrixx Initiatives Inc. (MTXX) plummeted 55.5% to $8.56 before trading was halted.

About 130 consumers since 1999 have reported a loss of smell after using Zicam products. Many said the condition occurred after their first dose, the FDA said. The agency advised anyone who has experienced problems after using Zicam products to contact a doctor.

Matrixx responds

The products named comprised about 40% of the company's net sales in 2009, according to a press release from Matrixx, which added that the company believes the Zicam products are safe and do not cause loss of smell.

Matrixx said the FDA's actions are "unwarranted" -- but the company is reviewing its options, which may include removing these products from the market.

A separate note on Matrixx's Web site zicamlawsuits.com, titled "Response to Those Who Are Concerned About Zicam's Purported Connection to Anosmia," says the products are safe and that "allegations to the contrary are scientifically unfounded and misleading."

However, the Matrixx note does acknowledge lawsuits that have been brought against the company, saying, "Although plaintiffs and their attorneys hoping for financial gain have sued Matrixx, no plaintiff has ever won a court case, because there is no known causal link."

Homeopathic drug regulations

Zicam is considered a "homeopathic remedy" rather than a drug. These types of products can be marketed without the government oversight required of "conventional" foods and drugs.

Manufacturers are not required to register their products with FDA, nor must they receive the FDA's approval before producing or selling these products.

The manufacturer is responsible for ensuring that the products are safe, and the FDA is responsible for taking action against any "unsafe" product after it reaches the market -- as it did with Zicam.

In its warning letter, the FDA said Matrixx was in violation of its regulations by failing to file a new drug application for the nasal gel and gel swabs, and that the products did not adequately warn of risks.

The agency sent Matrixx a warning letter saying these products can no longer be marketed without FDA approval, according to its press release. Matrixx has 15 business days to notify the FDA of specific steps taken to correct violations. To top of page

Features
They're hiring!These Fortune 100 employers have at least 350 openings each. What are they looking for in a new hire? More
If the Fortune 500 were a country...It would be the world's second-biggest economy. See how big companies' sales stack up against GDP over the past decade. More
Sponsored By:
More Galleries
8 must-have travel apps Whether you've got wanderlust or an airline grievance, here are some apps to pack onto your phone. More
Hot stocks: 10 record breaking companies The S&P 500 is trading at all-time highs, and many well-known businesses are leading the charge. Time to buy or sell? More
My biggest retirement mistake Five CNNMoney readers share stories about saving that you can learn from. What they would do differently if they had another chance. More
Worry about the hackers you don't know 
Crime syndicates and government organizations pose a much greater cyber threat than renegade hacker groups like Anonymous. Play
GE CEO: Bringing jobs back to the U.S. 
Jeff Immelt says the U.S. is a cost competitive market for advanced manufacturing and that GE is bringing jobs back from Mexico. Play
Hamster wheel and wedgie-powered transit 
Red Bull Creation challenges hackers and engineers to invent new modes of transportation. Play

Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.