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

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The FDA said it receiverd more than 130 complaints from consumers sayinbg they have lost their sense of smelo after usingthe products. Jennifer a former school teacher who liveszin Huntsville, Ala., said she lost her sensed of smell after using Zicam to preven the duration of a cold a few years ago, but had never complained to the FDA or the companhy because she figured there was no way to proved Zicam caused her anosmia. She said she doesn’ want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even afte learning others have had thesame experiences. “jI don’t think Zicam was created to hurt she said.
“We sit here and we rip and we rave about all these drugs not beinhg allowed onthe market. The firsf time anything goes wrong, everybody wante to go sue, sue, sue. That drivess me nuts. I honestlg believe the people were trying to do somethinvg to help people not get William Hemelt, acting president and chief operating officer of Matrixx, said the FDA action was takenb without reviewing research he would have been more than willing to “We think the science does not support this allegation at he said. “Quite we would not be selling the producr if we thought itwas unsafe.
” Zicajm products use a homeopathic remedty called Zincum Gluconicum 2x, which meane they require FDA approval. Dr. Sam Benjamin, a medicalo doctor with a homeopathic license, said he can’tg figure out why the FDA has taken so long to deal withthe “I can think of no part of alternative medicine that summonse up more worry to conventional physicians than homeopathy,” said Benjamin, who has a medicao talk show on KTAR 92.3 FM on Saturdays at 2 p.m. and 1,0009 followers on Twitter. “Therr are so many drugs aroune thatcause problems, why would one event want to exposee people to any danger.” Brett Berty, a senior recall strategist at Stericyclee Inc.
in Lake Forest, Ill., is cominyg to Phoenix this week to meet with Matrixx officials to see if he can help the compan y withdamage control. Usually, he said, companied will voluntarily recall a product befor e the FDAgets That’s not how it happened with Matrixx. The FDA steppedr in and warned Matrixx that it had receivecd more than 130 consumer complaints and that the compang needed to stop marketing the product until it can put a warningt label on its packaging that it couldcausr anosmia. Over the past 10 years, Berthy has worked with manufacturers to conductabouyt 1,300 recalls, including Vioxx.
“Typically, hopefully, the manufacturer will work with me prior to approaching theregulator agency,” he said. “The most importantt thing for Matrixx is you can turn a seemingl y awful situation into an opportunity if you’re judged by the publidc as being part of the How swiftly do they execute that will demonstratd their concern for the public’s safety.” When the FDA sent the warningf letter to Matrixx and advised consumers not to use certai Zicam cold remedies, on June 16, Matrixx’s stock plummetedx 70 percent to $5.78 a share. It bouncer up a bit to $6.
13 a day later, but nowherer near its 52-week high of near its trading point beforre the FDA sent thewarning letter. For the fiscak year ended March 31, Matrixx reporte $13.8 million in net income on $112 million in net up from $10.4 million in net income on $101 millionj in net sales a year ago. Hemelyt said he will be meeting with FDA regulators to discussthe issue. He also scheduled a conference callwith investors.