Sunday, October 7, 2012

Zicam maker pulls products, but affirms safety - Business Courier of Cincinnati:

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The FDA said it receivedc more than 130 complaints from consumers sayinf they have lost their sense of smell after usingthe products. Jennifer Warren, a forme r school teacher who livesin Huntsville, said she lost her sense of smello after using Zicam to prevent the duration of a cold a few yeare ago, but had never complained to the FDA or the compant because she figured therd was no way to prove Zicam causes her anosmia. She said she doesn’y want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even after learninh others have had thesame “I don’t think Zicam was createcd to hurt anyone,” she said.
“Wew sit here and we rip and we rave abougt all these drugs not beingb allowed onthe market. The first time anythin goes wrong, everybody wants to go sue, sue, sue. That drivesx me nuts. I honestly believe the people were trying to do somethin g to help people notget sick.” William acting president and chief operating officer of Matrixx, said the FDA actiomn was taken without reviewing research he would have been more than willing to provide.
“We thinko the science does not support this allegationat all,” he “Quite honestly, we would not be selliny the product if we thought it was Zicam products use a homeopathic remedy called Zincunm 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 taken so long to deal withthe issue. “I can thino of no part of alternative medicin that summons up more worry to conventionao physiciansthan homeopathy,” said Benjamin, who has a medicalp talk show on KTAR 92.3 FM on Saturdayes at 2 p.m. and 1,000 followers on Twitter.
“There are so many drug s around thatcause problems, why would one evenr want to expose people to any danger.” Brett a senior recall strategist at Stericycled Inc. in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrix officials to see if he can help the companuy withdamage control. Usually, he said, companiews will voluntarily recall a product before the FDAgets involved. 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 company needer to stop marketing the product until it can put a warning label on its packaging that it coulddcause anosmia.
Over the past 10 years, Berty has worked with manufacturers to conductfabout 1,300 recalls, including Vioxx. “Typically, the manufacturer will work with me prior to approachin g theregulatory agency,” he said. “The most importanty thing for Matrixx is you can turn a seemingly awfuk situation into an opportunityif you’re judged by the public as beinfg part of the solution. How swiftly do they execute that will demonstratw their concern forthe public’ss safety.” When the FDA sent the warning letter to Matrixx and advised consumers not to use certain Zica m cold remedies, on June 16, Matrixx’xs stock plummeted 70 percentf to $5.78 a share.
It bouncedf up a bit to $6.13 a day later, but nowhere near its 52-week high of $19.74, near its tradinh point before the FDA sent thewarning letter. For the fisca year ended March 31, Matrixz reported $13.8 million in net incom on $112 million in net sales, up from $10.4 million in net income on $101 million in net sales a year ago. Hemel t said he will be meeting with FDA regulatoras to discussthe issue. He also scheduled a conference callwith investors.

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