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US tells Zicam maker to stop selling some products
16 Jun 2009 18:14:55 GMT
Source: Reuters
* FDA urges consumers to stop taking intranasal products

* Shares of Zicam maker Matrixx fall 55.8 percent (Adds details from FDA notice to consumers, updates shares)

By Lisa Richwine

WASHINGTON, June 16 (Reuters) - U.S. regulators warned Matrixx Initiatives <MTXX.O> to stop selling intranasal versions of its zinc-containing Zicam cold remedy after more than 130 reports of people losing their sense of smell after using the products.

The U.S. Food and Drug Administration also urged consumers to stop taking the over-the-counter products, agency officials said on a conference call with reporters on Tuesday.

Matrixx shares fell 55.8 percent to $8.50 on Nasdaq.

The company must seek FDA approval if it wants to continue selling the Zicam zinc products that are administered through the nose, agency officials said.

The company and its representatives did not return calls seeking a comment. Matrixx has repeatedly defended the products in the past, saying there was no direct link between Zicam and loss of smell.

The FDA warning applies to Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. A public health advisory posted on the FDA website said the products "have all been associated with long lasting or permanent loss of smell" and "have not been shown to be effective in the reduction of the duration and severity of cold symptoms."

The action does not affect Zicam oral zinc tablets or lozenges, the FDA said.

The FDA in its notice to consumers said many people who experienced a loss of smell said the condition occurred with the first Zicam dose, while others reported loss of sense of smell after multiple uses of the products.

The agency noted that loss of sense of smell can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment, and said affected patients should contact their doctors. (Reporting by Lisa Richwine and Bill Berkrot in New York; editing by Maureen Bavdek, John Wallace, Dave Zimmerman)


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Last updated:Tue Jun 16 18:16:16 2009