Zicam

Zicam Cold Remedy Gets FDA Warning; Matrixx Dives
June 16 (Bloomberg) -- Zicam nasal sprays and swabs may cause permanent loss of smell and taste and consumers should stop using them, U.S. regulators warned today, sending shares of manufacturer Matrixx Initiatives Inc. down the most ever.

Matrixx, based in Scottsdale, Arizona, fell $10.68, or 56 percent, to $8.56 before Nasdaq Stock Market trading was halted. That’s the biggest intraday decline since its 1996 initial public offering.

The Food and Drug Administration has received more than 130 reports of people losing their sense of smell after using zinc- based Zicam nasal spray and swabs, and Matrixx has an additional 800 reports it hasn’t made available to the agency, Deborah M. Autor, director of the FDA’s Office of Compliance, said today in a conference call with reporters. The agency sent a warning letter to Matrixx telling the company to stop selling three Zicam products.

“If they wish to continue marketing the products, the next step is for them to come in and seek FDA approval,” Autor said....



Cold remedy linked to loss of sense of smell
Zicam Cold Remedy, a homeopathic product sold in drugstores, may cause users to permanently lose their sense of smell, the U.S. Food and Drug Administration warned manufacturer Matrixx Initiatives Inc.
The FDA said there’s no proof the product is safe or effective and gave the closely held maker, based in Scottsdale, Ariz., 15 days to reply to the warning....


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