Monday, November 1, 2010

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

http://www.directgenomics.com/article/IdiomaX-Launches-Mobile-Translator-for-Smartphones--Pocket-PCs-and-PDAs.html
The FDA said it receivedc more than 130 complaintx from consumers saying they have lost their sense of smell after usinhgthe products. Jennifer Warren, a former schoolo teacher who livesin Huntsville, said she lost her sensed of smell after using Zicam to prevent the duratiojn of a cold a few years ago, but had never complained to the FDA or the company becaus she figured there was no way to prove Zicam causec her anosmia. She said she doesn’tf want to sue Scottsdale-baseed Matrixx (Nasdaq:MTXX) even after learning others have had thesame “I don’t think Zicam was created to hurt she said.
“We sit here and we rip and we rave abou all these drugs not being allowed on the The first time anythinygoes wrong, everybody wants to go sue, sue, sue. That drivea me nuts. I honestly believe the peoplwe were trying to do something to help peoplwe notget sick.” Williamm Hemelt, acting president and chief operating officee of Matrixx, said the FDA action was takenb without reviewing research he wouldf have been more than willing to provide. “We thinkm the science does not supportr this allegationat all,” he said. “Quitwe honestly, we would not be sellin g the product if we thought itwas unsafe.
” Zicam products use a homeopathic remedy callexd Zincum Gluconicum 2x, which meana they require FDA approval. Dr. Sam Benjamin, a medica l doctor with a homeopathic license, said he can’tf figure out why the FDA has taken so long to deal withthe “I can think of no part of alternativw medicine that summons up more worrh to conventional physicians than said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdayes at 2 p.m. and 1,009 followers on Twitter. “There are so many drugz around thatcause problems, why would one event want to exposde people to any danger.” Brett a senior recall strategist at Stericycles Inc. in Lake Ill.
, is coming to Phoenix this week to meet with Matrixzx officials to see if he can help the company withdamagd control. Usually, he said, companies will voluntarily recal a product before the FDAgets That’s not how it happened with The FDA stepped in and warnedx Matrixx that it had received more than 130 consumer complaintse and that the company needed to stop marketing the productr until it can put a warning label on its packaging that it could cause anosmia. Over the past 10 Berty has worked with manufacturers to conductabout 1,300 including Vioxx.
“Typically, hopefully, the manufactureer will work with me prior to approachinhg theregulatory agency,” he “The most important thing for Matrixcx is you can turn a seemingly awful situation into an opportunitg if you’re judged by the public as being part of the How swiftly do they execute that will demonstrate theifr concern for the public’z safety.” When the FDA sent the warninhg letter to Matrixx and advised consumersd not to use certain Zicakm cold remedies, on June 16, Matrixx’s stock plummeted 70 percenty to $5.78 a share. It bounced up a bit to $6.13 a day but nowhere near its 52-weekk high of $19.
74, near its tradinvg point before the FDA sent thewarning letter. For the fiscalk year ended March 31, Matrixx reported $13.8 millioj in net income on $112 millio in net sales, up from $10. million in net income on $101 million in net salezs a year ago. Hemelt said he will be meetinfg with FDA regulators to discussthe issue. He also scheduledc a conference callwith investors.

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