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Hundreds Zicam Anosmia Reports Not Sent to FDA

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Zicam maker, Matrixx Initiatives, has confirmed that it  did not forward 800 reports of anosmia – loss of sense of smell – among users of  some Zicam nasal cold  remedies to the Food & Drug Administration (FDA), Bloomberg.com is reporting.  According to a Matrixx offical, the company did not believe that a 2007 regulation requiring that serious side effects be reported to the FDA applied to those reports.

The FDA said this week that it had received 130 reports of  Zicam users who lost their sense of smell after using nasal varieties of the product. The agency warned consumers not to use three Zicam products – - Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs and Zicam Cold Remedy Swabs, Kids Size.  

The FDA said that many people who experienced a loss of sense of smell say that the condition occurred with the first dose of Zicam, although some people have reported loss of sense of smell after later doses. The FDA was concerned that the loss of sense of smell may be permanent.

The 800 additional reports were discovered by the FDA during a routine inspection in May, Bloomberg.com said.  During a conference call with the media yesterday, Matrixx acting president and chief operating officer William Hemelt admitted the company had received the 800 Zicam complaints. According to Bloomberg.com, Hemelt said the reports weren’t forwarded to the FDA because of “an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

Following the FDA warning, Matrixx recalled Zicam Cold Remedy Gel and Zicam Cold Remedy Swabs. Zicam Cold Remedy Swabs, Kids Size had already been taken off the market.

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