Monday, November 22, 2010

Zicam maker pulls products, but affirms safety - Kansas City Business Journal:

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The FDA said it received more than 130 complaint from consumers saying they have lost their sense of smel l after usingthe products. Jennifer Warren, a formeer school teacher who livesin Ala., said she lost her sensew of smell after using Zicam to preventy the duration of a cold a few yearzs ago, but had never complained to the FDA or the compant because she figured there was no way to prove Zicam caused her anosmia. She said she doesn’gt want to sue Scottsdale-base d Matrixx (Nasdaq:MTXX) even after learning othersz have had thesame “I don’t think Zicam was created to hurt anyone,” she said.
“Wew sit here and we rip and we rave about all thesde drugs not being allowed onthe market. The firsr time anything goes wrong, everybody wantx to go sue, sue, sue. That drivess me nuts. I honestly believde the people were tryinbg to do something to help people not get William Hemelt, acting president and chier operating officer of Matrixx, said the FDA action was takem without reviewing research he would have been more than willint to provide. “We think the science does not supporty this allegationat all,” he said. “Quite honestly, we woulc not be selling the product if we thought itwas unsafe.
” Zicam products use a homeopathifc remedy called Zincum Gluconicum 2x, which mean they require FDA approval. Dr. Sam Benjamin, a medical doctor with a homeopathic license, said he can’ft figure out why the FDA has takenn so long to deal withthe issue. “I can think of no part of alternative medicine that summons up more worry to conventionao physiciansthan homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdayds at 2 p.m. and 1,000 followersw on Twitter. “There are so many drugxs around that cause why would one event want to expose people to any Brett Berty, a senior recall strategist at Stericyclde Inc. in Lake Forest, Ill.
, is cominyg to Phoenix this week to meet with Matrixx officialzs to see if he can help the companyu withdamage control. Usually, he said, companies will voluntarilt recall a product before the FDAgets That’s not how it happenedc with Matrixx. The FDA steppec in and warned Matrixs that it had received more than 130 consumef complaints and that the company needed to stop marketinv the product until it can put a warningf label on its packaging that it couldccause anosmia.
Over the past 10 years, Berty has workede with manufacturers to conductabout 1,300 recalls, including “Typically, hopefully, the manufacturer will work with me priorf to approaching the regulatory agency,” he said. “The most important thing for Matrixx is you can turn a seeminglyu awful situation into an opportunittyif you’re judged by the publicv as being part of the solution. How swiftly do they executer that will demonstrate their concern forthe public’a safety.” When the FDA sent the warning letter to Matrixxs and advised consumers not to use certain Zicam cold on June 16, Matrixx’s stoc k plummeted 70 percent to $5.78 a share.
It bouncec up a bit to $6.13 a day but nowhere near its 52-week high of $19.74, near its trading point before the FDA sent the warning For the fiscal year endedMarch 31, Matrixx reported $13.8 million in net incom on $112 million in net up from $10.4 million in net income on $101 millionm in net sales a year ago. Hemelf said he will be meeting with FDA regulators to discusasthe issue. He also scheduled a conference callwith

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