Tuesday, September 4, 2012

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

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The FDA said it received more than 130 complaintsw from consumers saying they have lost their senses of smell after usingthe products. Jennifer a former school teacher who livesin Huntsville, Ala., said she lost her senser of smell after usin Zicam to prevent the duration of a cold a few yearsx ago, but had never complained to the FDA or the compangy because she figured ther e was no way to prove Zicam caused her anosmia. She said she doesn’t want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even aftetr 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 abouyt all these drugs not beinh allowed onthe market. The first time anythingy goes wrong, everybody wants to go sue, sue, sue. That drived me nuts. I honestly believe the people were tryingy to do something to help people notget sick.” William Hemelt, acting president and chiefd operating officer of Matrixx, said the FDA actiom was taken without reviewing research he would have been more than willinb to provide. “We think the science does not support this allegationnat all,” he said. “Quite we would not be selling the producy if we thought itwas unsafe.
” Zicam products use a homeopathiv remedy called Zincum Gluconicum 2x, which meanws they require FDA approval. Dr. Sam Benjamin, a medicalp doctor with a homeopathic license, said he can’t figure out why the FDA has take n so long to deal withthe issue. “ can think of no part of alternatives medicine that summons up more worry to conventional physiciansathan homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdayas at 2 p.m. and 1,000 followers on “There are so many drugs aroun thatcause problems, why would one eventy want to expose people to any danger.” Bretgt Berty, a senior recall strategisft at Stericycle Inc.
in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrix officials to see if he can help the compan withdamage control. Usually, he said, companies will voluntarily recall a product before the FDAgets involved. That’e not how it happened with Matrixx. The FDA steppe d in and warned Matrixx that it had receivef more than 130 consumer complaints and that the compang needed to stop marketing the product untilo it can put a warninyg label on its packagingy that it couldcause anosmia. Over the past 10 Berty has worked with manufacturers to conductabouyt 1,300 recalls, including Vioxx.
hopefully, the manufacturer will work with me prior to approaching theregulatory agency,” he “The most important thing for Matrixdx is you can turn a seemingly awful situationh into an opportunity if you’re judged by the public as beinvg part of the solution. How swiftly do they execute that will demonstrate their concern forthe public’s safety.” When the FDA sent the warninfg letter to Matrixx and advised consumers not to use certaibn Zicam cold remedies, on June 16, Matrixx’sd stock plummeted 70 percent to $5.78 a share. It bounced up a bit to $6.13 a day but nowhere near its 52-weemk high of $19.
74, near its trading pointr before the FDA sent thewarninh letter. For the fiscal year ended Marcu 31, Matrixx reported $13.8 million in net income on $112 million in net sales, up from $10.3 million in net income on $101 million in net salees a year ago. Hemelt said he will be meetingt with FDA regulators to discussthe issue. He also scheduledf a conference callwith investors.

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