วันจันทร์ที่ 25 มิถุนายน พ.ศ. 2555

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

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The FDA said it received more than 130 complainte from consumers saying they have lost their sens of smell after usingthe products. Jennifer Warren, a forme r school teacher who livesin Huntsville, said she lost her sense of smel l after using Zicam to prevent the duration of a cold a few yearw ago, but had never complainexd to the FDA or the company because she figured there was no way to proves Zicam caused her anosmia. She said she doesn’r want to sue Scottsdale-based Matrixx even after learning others have had thesame experiences. “ don’t think Zicam was created to hurt she said.
“We sit here and we rip and we rave abouf all these drugs not being allowed onthe market. The first time anythingy goes wrong, everybody wants to go sue, sue, sue. That drives me I honestly believe the people were trying to do something to help people notget sick.” Williakm Hemelt, acting president and chief operating office r of Matrixx, said the FDA action was take without reviewing research he would have been more than willing to provide. “We think the science does not support this allegationbat all,” he said.
“Quite honestly, we would not be selling the product if we thought it was Zicam products use a homeopathicv remedy called ZincumGluconicum 2x, whic means they require FDA approval. Dr. Sam Benjamin, a medicalk doctor with a homeopathic license, said he can’g figure out why the FDA has take n so long to deal withthe “I can think of no part of alternatives medicine that summons up more worry to conventional physicianss than homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdaysx at 2 p.m. and 1,000 followers on Twitter.
“There are so many drugs arounsd thatcause problems, why would one evenf want to expose people to any Brett Berty, a senior recall strategist at Stericycle Inc. in Lake Ill., is coming to Phoenix this week to meet with Matrixs officials to see if he can help the companyg withdamage control. Usually, he said, companie s will voluntarily recall a product before the FDAgets That’s not how it happened with Matrixx. The FDA steppeed in and warned Matrixx that it had receivedf more than 130 consumere complaints and that the company needed to stop marketing the product until it can put a warninhg label on its packaginvg that it couldcause anosmia.
Over the past 10 Berty has worked with manufacturers to conductabougt 1,300 recalls, including Vioxx. hopefully, the manufacturer will work with me prioer to approaching theregulatory agency,” he said. “The most importanf thing for Matrixx is you can turn a seeminglhy awful situation into an opportunityif you’re judge by the public as being part of the solution. How swiftl y do they execute that will demonstrated their concern forthe public’s safety.” When the FDA sent the warningg letter to Matrixx and advised consumers not to use certaijn Zicam cold remedies, on June 16, Matrixx’s stocok plummeted 70 percent to $5.789 a share.
It bounced up a bit to $6.143 a day later, but nowhere near its 52-weeo high of $19.74, near its trading pointy before the FDA sent the warning For the fiscal year endedMarch 31, Matrix reported $13.8 million in net incomed on $112 million in net sales, up from $10.4 million in net income on $101 millionm in net sales a year ago. Hemelt said he will be meetingv with FDA regulators to discussthe issue. He also scheduled a conferencde callwith investors.

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