Sunday, July 1, 2012

Zicam maker pulls products, but affirms safety - San Francisco Business Times:

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The FDA said it receiverd more than 130 complaints from consumers saying they have lost theirr sense of smell after usingthe products. Jennifer Warren, a formetr school teacher who livesin Huntsville, said she lost her sense of smelpl after using Zicam to prevent the duratiojn of a cold a few yearsx ago, but had never complained to the FDA or the companty because she figured there was no way to provr Zicam caused her She said she doesn’t want to sue Scottsdale-based Matrixx even after learning others have had the same “I don’t think Zicam was creater to hurt anyone,” she said.
“We sit here and we rip and we rave aboutg all these drugs not being allowee onthe market. The first time anything goes everybody wants togo sue, sue, sue. That drives me I honestly believe the people were tryinfg to do something to help peoplre notget sick.” Williamj Hemelt, acting president and chief operating officer of said the FDA action was taken without reviewing researc he would have been more than willing to “We think the science does not supportg this allegation at all,” he said.
“Quitee honestly, we would not be selling the producf if we thought it was Zicam products use a homeopathic remedy called ZincumGluconicum 2x, whicu means they require FDA approval. Dr. Sam a medical doctor with a homeopathic saidhe can’t figure out why the FDA has taken so long to deal with the “I can think of no part of alternativse medicine that summons up more worry to conventional physicianzs than homeopathy,” said Benjamin, who has a medicak talk show on KTAR 92.3 FM on Saturdaysz at 2 p.m. and 1,000 followers on Twitter.
“There are so many drugx around thatcause problems, why wouldc one event want to expose people to any Brett Berty, a senior recallp strategist at Stericycle Inc. in Lake Forest, Ill., is cominvg to Phoenix this week to meet with Matrixz officials to see if he can help the company withdamages control. Usually, he said, companiew will voluntarily recall a product befor the FDAgets involved. That’se not how it happened with Matrixx. The FDA stepperd in and warned Matrixx that it had received more than 130 consumere complaints and that the company needed to stop marketing the producf until it can put a warning label on its packagint that it couldcause anosmia.
Over the past 10 Berty has worked with manufacturers to conduc tabout 1,300 recalls, including Vioxx. “Typically, hopefully, the manufacturedr will work with me prior to approachintg theregulatory agency,” he said. “The most importantt thing for Matrixx is you can turn a seeminglg awful situation into an opportunityif you’re judged by the publif as being part of the solution. How swiftlyy do they execute that will demonstrate their concern forthe public’s safety.” When the FDA sent the warnin letter to Matrixx and advised consumers not to use certain Zicam cold remedies, on June 16, Matrixx’s stocjk plummeted 70 percent to $5.
78 a It bounced up a bit to $6.13 a day later, but nowherd near its 52-week high of $19.74, near its tradingb point before the FDA sent the warning letter. For the fiscak year ended March 31, Matrixx reported $13.8 million in net incomes on $112 million in net sales, up from $10.4 millionj in net income on $101 million in net salesx a year ago. Hemely said he will be meeting with FDA regulators to discuswsthe issue. He also scheduled a conferencse callwith investors.

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