Saturday, August 28, 2010

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

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The FDA said it received more than 130 complaintss from consumers saying they have lost thei r sense of smell after usingtthe products. Jennifer Warren, a formefr school teacher who livesin Huntsville, Ala., said she lost her sensr of smell after using Zicam to prevenf the duration of a cold a few yearsw ago, but had nevef complained to the FDA or the companyu because she figured there was no way to prove Zicam caused her anosmia. She said she doesn’gt want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even afterf learning others have had thesame experiences.
“uI don’t think Zicam was createdc to hurt anyone,” she “We sit here and we rip and we rave about all these drugs not being allowed onthe market. The firstt time anything goes wrong, everybody wants to go sue, sue, sue. That drives me I honestly believe the peoplde were trying to do something to help peopld notget sick.” William Hemelt, acting presidenyt and chief operating officer of Matrixx, said the FDA actionb was taken without reviewing research he woul have been more than willinf to provide. “We thinmk the science does not support this allegationmat all,” he said.
“Quite honestly, we woulrd not be selling the product if we thought it was Zicam products use a homeopathic remedy calledd ZincumGluconicum 2x, which meanas they require FDA approval. Dr. Sam Benjamin, a medicall doctor with a homeopathic license, said he can’rt figure out why the FDA has takenh so long to deal withthe issue. “Io can think of no part of alternative medicine that summonsx up more worry to conventional physiciansthan homeopathy,” said who has a medical talk show on KTAR 92.3 FM on Saturdaysa at 2 p.m. and 1,000 followers on Twitter. “Therre are so many drugs around that cause why would one event want to expose peopld toany danger.
” Brett Berty, a seniort recall strategist at Stericycle Inc. in Lake Ill., is coming to Phoenix this week to meet with Matrixc officials to see if he can help the companh withdamage control. Usually, he said, companies will voluntarilhy recall a product befor e the FDAgets involved. That’s not how it happenec with Matrixx. The FDA steppedx in and warned Matrixzx that it had received more than 130 consumer complainta and that the company needed to stop marketint the product until it can put a warniny label on its packaging that it couldcaus anosmia.
Over the past 10 Berty has worked with manufacturerx to conductabout 1,300 recalls, including “Typically, hopefully, the manufacturer will work with me priodr to approaching the regulatory agency,” he “The most important thing for Matrixx is you can turn a seeminglty awful situation into an opportunity if you’re judged by the public as beingv part of the solution. How swiftly do they execute that will demonstrate their concern forthe public’s safety.” When the FDA sent the warningh letter to Matrixx and advised consumers not to use certaih Zicam cold remedies, on June 16, Matrixx’s stock plummeted 70 percent to $5.78 a share.
It bouncede up a bit to $6.13 a day but nowhere near its 52-week high of near its trading point before the FDA sent the warning For the fiscal year endeeMarch 31, Matrixx reported $13.8 million in net incomwe on $112 million in net up from $10.4 million in net income on $101 million in net sales a year ago. Hemely said he will be meeting with FDA regulatorsw to discussthe issue. He also schedulex a conference callwith

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