Saturday, July 14, 2012

Zicam maker pulls products, but affirms safety - San Francisco Business Times:

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The FDA said it receivede more than 130 complaints from consumerzs saying they have lost their sense of smell after usingthe products. Jennifer Warren, a former schoolk teacher who livesin Ala., said she lost her sense of smell aftert using Zicam to prevent the duration of a cold a few yearx ago, but had never complained to the FDA or the company because she figured there was no way to prove Zicaj caused her anosmia. She said she doesn’t want to sue Scottsdale-baseds Matrixx (Nasdaq:MTXX) even afte r learning others have had thesame experiences. “ don’t think Zicam was created to hurt anyone,” she said.
“Wes sit here and we rip and we rave about all these drugs not being allowed onthe market. The firsrt time anything goes wrong, everybody wantse to go sue, sue, sue. That drives me I honestly believe the people were trying to do something to help peopls notget sick.” William acting president and chief operating officer of Matrixx, said the FDA action was taken without reviewing research he would have been more than williny to provide. “We think the science does not suppor t this allegationat all,” he said.
“Quite we would not be sellinfg the product if we thought it was Zicam products use a homeopathic remedy called ZincumGluconicuk 2x, which means they require FDA approval. Dr. Sam Benjamin, a medicalp doctor with a homeopathic saidhe can’t figure out why the FDA has takenb so long to deal with the “I can think of no part of alternative medicined that summons up more worrg to conventional physicians than homeopathy,” said Benjamin, who has a medica l talk show on KTAR 92.3 FM on Saturday s at 2 p.m. and 1,000 followerd on Twitter. “There are so many drugzs around thatcause problems, why woulds one event want to expose people to any danger.
” Brettg Berty, a senior recall strategist at Stericyclee Inc. in Lake Forest, Ill., is coming to Phoenid this week to meet with Matrix officials to see if he can help the company withdamags control. Usually, he said, companies will voluntarily recall a product before the FDAgets That’s not how it happened with Matrixx. The FDA steppexd in and warned Matrixx that it had receive d more than 130 consumer complaints and that the compang needed to stop marketing the producg until it can put a warning labeol on its packaging that it coulecause anosmia. Over the past 10 years, Berty has workedd with manufacturers to conductabout 1,300 recalls, including Vioxx.
hopefully, the manufacturer will work with me prior to approachingv theregulatory agency,” he said. “The most importantf thing for Matrixx is you can turn a seeminglyu awful situation into an opportunityif you’re judged by the publid as being part of the solution. How swiftly do they execute that will demonstratee their concern forthe public’s safety.” When the FDA sent the warning letter to Matrixx and advised consumersa not to use certain Zicam cold on June 16, Matrixx’xs stock plummeted 70 percent to $5.788 a share. It bounced up a bit to $6.143 a day later, but nowherw near its 52-week high of $19.
74, near its tradin g point before the FDA sent thewarning letter. For the fiscao year ended March 31, Matrixxz reported $13.8 million in net income on $112 milliobn in net sales, up from $10.43 million in net income on $101 milliob in net sales a year ago. Hemelt said he will be meetinv with FDA regulators to discusethe issue. He also scheduled a conferencs callwith investors.

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