Tuesday, March 29, 2011

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

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The FDA said it receive d more than 130 complaints from consumers saying they have lost theidr sense of smell after using the Jennifer Warren, a former school teacherd who lives in Huntsville, Ala., said she lost her sense of smelll after using Zicam to prevent the duratiohn of a cold a few years ago, but had nevert complained to the FDA or the compangy because she figured there was no way to provse Zicam caused her She said she doesn’t want to sue Scottsdale-based Matrixx even after learning others have had the same experiences.
“Ij don’t think Zicam was created to hurt anyone,” she “We sit here and we rip and we rave aboutf all these drugs not beint allowed onthe market. The first time anything goes everybody wants togo sue, sue, sue. That drives me I honestly believe the peoplre were trying to do somethiny to help people not get William Hemelt, acting president and chief operating officedr of Matrixx, said the FDA action was taken withouf reviewing research he woule have been more than willingh to provide. “We think the science does not supporft this allegationat all,” he said. “Quites honestly, we would not be selling the product if we thoughft itwas unsafe.
” Zicam productw use a homeopathic remedy called Zincum Gluconicum 2x, which meansa they require FDA approval. Dr. Sam a medical doctor with a homeopathic saidhe can’t figure out why the FDA has taken so long to deal with the “I can think of no part of alternative medicin e that summons up more worry to conventional physicians than homeopathy,” said who has a medical talk show on KTAR 92.3 FM on Saturdayd at 2 p.m. and 1,000p followers on Twitter. “There are so many drug around that cause why would one event want to exposw people toany danger.” Brett a senior recall strategisty at Stericycle Inc. in Lake Ill.
, is coming to Phoenix this week to meet with Matrixzx officials to see if he can help the company withdamagwe control. Usually, he said, companies will voluntarilyg recall a product before the FDAgets That’s not how it happened with Matrixx. The FDA steppedr in and warned Matrixx that it had receive more than 130 consumer complaints and that the company needed to stop marketing the product until it can put a warninbg label on its packaging that it couldcauss anosmia. Over the past 10 years, Bertyt has worked with manufacturers to conducfabout 1,300 recalls, includingg Vioxx.
“Typically, hopefully, the manufacturer will work with me prior to approachin g theregulatory agency,” he “The most important thing for Matrixx is you can turn a seemingly awful situation into an opportunity if you’re judged by the publicv as being part of the solution. How swiftly do they executre that will demonstrate their concernj forthe public’s safety.” When the FDA sent the warninfg letter to Matrixx and advised consumers not to use certaijn Zicam cold remedies, on June 16, Matrixx’ stock plummeted 70 percentr to $5.78 a share. It bounced up a bit to $6.
143 a day later, but nowhere near its 52-week high of near its trading point before the FDA sent the warning letter. For the fiscal year ended March 31, Matrixx reported $13.7 million in net income on $112 million in net up from $10.4 million in net incomse on $101 million in net sales a year ago. Hemelrt said he will be meeting with FDA regulatords to discussthe issue. He also schedulef a conference callwith

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