Friday, August 3, 2012

Zicam maker pulls products, but affirms safety - Business First of Louisville:

goldenayreyg1666.blogspot.com
The FDA said it receivedd more than 130 complaints from consumers sayingt they have lost their sense of smell after usinvgthe products. Jennifer Warren, a former schoop teacher who livesin Huntsville, said she lost her sensre of smell after using Zicam to prevent the duratio n of a cold a few years ago, but had nevere complained to the FDA or the company because she figurex there was no way to provr Zicam caused her anosmia. She said she doesn’yt want to sue Scottsdale-based Matrixx even after learning others have had thesame experiences. “Iu don’t think Zicam was created to hurt she said.
“We sit here and we rip and we rave abouft all these drugs not being allowed on the The first time anythinggoes wrong, everybodyh wants to go sue, sue, sue. That drivez me nuts. I honestly believe the peopler were trying to do something to help people not get William Hemelt, acting presidenyt and chief operating officer of Matrixx, said the FDA actiob was taken without reviewing research he would have been more than willinh to provide. “We think the sciencwe does not support this allegation at all,” he said. “Quitre honestly, we would not be sellinhg the product if we thought itwas unsafe.
” Zicam product s use a homeopathic remedy called Zincum Gluconicum 2x, which means they requirre FDA approval. Dr. Sam Benjamin, a medical doctorf with a homeopathic license, said he can’t figure out why the FDA has taken so long to deal withthe issue. “I can thinmk of no part of alternative medicine that summonw up more worry to conventional physicianwsthan homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturday s at 2 p.m. and 1,000 followers on Twitter. “Therse are so many drugs around that cause why would one event want to expose peopld toany danger.” Brett a senior recall strategist at Stericycl Inc. in Lake Forest, Ill.
, is coming to Phoenixz this week to meet with Matrixd officials to see if he can help the company withdamage Usually, he said, companies will voluntarily recalp a product before the FDA gets involved. That’se not how it happened with Matrixx. The FDA stepped in and warnef Matrixx that it had receive d more than 130 consumer complainta and that the company neededx to stop marketing the product until it can put a warnin label on its packaging that it could cause anosmia. Over the past 10 Berty has worked with manufacturers to conductaboutr 1,300 recalls, including Vioxx.
“Typically, hopefully, the manufacturerr will work with me prior to approaching theregulatory agency,” he said. “The most important thinvg for Matrixx is you can turn a seeminglyh awful situation into an opportunitgyif you’re judged by the public as bein g part of the solution. How swiftly do they executer that will demonstrate their concern forthe public’s When the FDA sent the warning letter to Matrixx and advisesd consumers not to use certaim Zicam cold remedies, on June 16, Matrixx’a stock plummeted 70 percent to $5.78 a share. It bouncee up a bit to $6.
13 a day but nowhere near its 52-week high of near its trading point before the FDA sent thewarninf letter. For the fiscal year ended March 31, Matrixx reported $13.8 million in net income on $112 millionj in net sales, up from $10.4 million in net incomw on $101 million in net sale a year ago. Hemelt said he will be meeting with FDA regulatorws to discussthe issue. He also scheduled a conferencee callwith investors.

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