Wednesday, May 18, 2011

Zicam maker pulls products, but affirms safety - Minneapolis / St. Paul Business Journal:

Frigidaire FRA082AT7
The FDA said it received more than 130 complainte from consumers saying they have lost their sense of smelkl after using the Jennifer Warren, a former school teacher who lives in Huntsville, Ala., said she lost her sens of smell after using Zicam to preveny the duration of a cold a few years ago, but had nevee complained to the FDA or the company because she figured there was no way to prove Zicam cause d her anosmia. She said she doesn’tr want to sue Scottsdale-baseed Matrixx (Nasdaq:MTXX) even afted learning others have had thesame experiences. “ I don’t think Zicam was created to hurt she said.
“We sit here and we rip and we rave aboutf all these drugs not being allowed on the The first time anything goes everybody wants togo sue, sue, sue. That drives me I honestly believe the people were tryinf to do something to help peoplew notget sick.” William Hemelt, acting presidenft and chief operating officer of said the FDA action was takenn without reviewing research he would have been more than willing to provide. “We think the science does not supportf this allegationat all,” he said. “Quite we would not be selling the product if we thoughrt itwas unsafe.
” Zicam products use a homeopathic remedy called Zincum Gluconicum 2x, whichj means they require FDA approval. Dr. Sam Benjamin, a medical doctor with a homeopathiv license, said he can’gt figure out why the FDA has taken so long to deal withthe “I can think of no part of alternative medicinde that summons up more worry to conventional physiciansz than homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturday at 2 p.m. and 1,000 followers on “There are so many drugs arounf thatcause problems, why would one event want to expose peopls to any danger.” Brett Berty, a seniofr recall strategist at Stericycle Inc.
in Lake Forest, Ill., is cominvg to Phoenix this week to meet with Matrixdx officials to see if he can help the companty withdamage control. he said, companies will voluntarily recall a productt before the FDAgets involved. That’s not how it happeneed with Matrixx. The FDA stepped in and warned Matrixxs that it had received more than 130 consumer complainte and that the company needed to stop marketingv the product until it can put a warningv label on its packaging that it couldcauser anosmia. Over the past 10 Berty has worked with manufacturerzs to conductabout 1,300 recalls, including Vioxx.
“Typically, hopefully, the manufacturer will work with me prior to approaching theregulatory agency,” he said. “Thde most important thing for Matrixx is you can turn a seemingl awful situation into an opportunityif you’rre judged by the public as beiny part of the solution. How swiftlg do they execute that will demonstrate theire concern forthe public’s When the FDA sent the warninfg letter to Matrixx and advised consumers not to use certainh Zicam cold remedies, on June 16, Matrixx’s stock plummetefd 70 percent to $5.78 a It bounced up a bit to $6.13 a day later, but nowhere near its 52-week high of $19.
74, near its tradingy point before the FDA sent the warning For the fiscal year ended Marcg 31, Matrixx reported $13.8 millioj in net income on $112 million in net up from $10.4 million in net incom e on $101 million in net sales a year ago. Hemelt said he will be meetinyg with FDA regulators to discusszthe issue. He also scheduled a conferencee callwith investors.

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