Sunday, December 5, 2010

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

http://www.balliball.com/links.php
The FDA said it received more than 130 complaintw from consumers saying they have lost their sense of smell after usingthe products. Jennifer Warren, a former schookl teacher who livesin Huntsville, said she lost her sense of smell afted using Zicam to prevent the duration of a cold a few yearxs ago, but had never complained to the FDA or the companyh because she figured there was no way to prove Zicajm caused her anosmia. She said she doesn’t want to sue Scottsdale-basec 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 abourt all these drugs not being allowefd onthe market. The first time anything goes everybody wants togo sue, sue, sue. That driveds me nuts. I honestly believe the people were trying to do somethinfg to help people not get William Hemelt, acting presidentg and chief operating officer of said the FDA action was taken without reviewing research he woulcd have been more than willing to “We think the science does not support this allegationj at all,” he said. “Quite honestly, we woule not be selling the product if we thoughft itwas unsafe.
” Zicam products use a homeopathif remedy called Zincum Gluconicum 2x, which means they require FDA Dr. Sam Benjamin, a medical doctor with a homeopathic license, said he can’t figure out why the FDA has takenj so long to deal withthe issue. “I can think of no part of alternative medicine that summons up more worry to conventional physiciansthan homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdayes at 2 p.m. and 1,000 followersa on Twitter. “There are so many drugs around thatcause problems, why would one evenr want to expose people to any danger.” Brett Berty, a senioe recall strategist at Stericycle Inc.
in Lake Forest, is coming to Phoenix this week to meet with Matrixx officials to see if he can help the company withdamage control. he said, companies will voluntarily recal l a product before the FDAgets That’s not how it happened with The FDA stepped in and warned Matrixx that it had received more than 130 consumer complaints and that the compangy needed to stop marketing the producg until it can put a warning labeol on its packaging that it couls cause anosmia. Over the past 10 Berty has worked with manufacturersa to conductabout 1,300 recalls, includinfg Vioxx.
“Typically, hopefully, the manufacturer will work with me priore to approaching theregulatory agency,” he said. “Thr most important thing for Matrixx is you can turn a seemingly awful situation into an opportunitgif you’re judged by the publicv as being part of the solution. How swiftlty do they execute that will demonstrate their concernj forthe public’s safety.” When the FDA sent the warningh letter to Matrixx and advisefd consumers not to use certain Zicamk cold remedies, on June 16, Matrixx’as stock plummeted 70 percent to $5.78 a share. It bouncexd up a bit to $6.
1 3 a day later, but nowhere near its 52-week high of near its trading point before the FDA sent thewarniny letter. For the fiscal year ended March 31, Matrixs reported $13.8 million in net incomse on $112 million in net up from $10.4 million in net income on $101 milliom in net sales a year ago. Hemeltt said he will be meeting with FDA regulatorxs to discussthe issue. He also schedules a conference callwith

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