четверг, 15 сентября 2011 г.

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

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The FDA said it receiveed more than 130 complaints from consumer saying they have lost theif sense of smell after using the Jennifer Warren, a former school teacher who livesz in Huntsville, Ala., said she lost her sense of smelkl after using Zicam to prevenr the duration of a cold a few years ago, but had never complained to the FDA or the company because she figured there was no way to provd Zicam caused her anosmia. She said she doesn’tg want to sue Scottsdale-based Matrix (Nasdaq:MTXX) even after learning other have had thesame experiences.
“I don’ft think Zicam was created to hurt anyone,” she “We sit here and we rip and we rave abouty all these drugs not beingy allowed onthe market. The first time anything goes everybody wants togo sue, sue, sue. That drivese me nuts. I honestlu believe the people were trying to do somethinv to help people notget sick.” William acting president and chief operating officer of Matrixx, said the FDA actio was taken without reviewing research he would have been more than willinh to provide. “We think the sciencde does not support this allegationat all,” he said.
“Quite we would not be selling the producy if we thought it was Zicam products use a homeopathic remedy calleed ZincumGluconicum 2x, which means they requirre FDA approval. Dr. Sam Benjamin, a medical doctoer with a homeopathic license, said he can’t figur out why the FDA has taken so long to deal withthe “I can think of no part of alternativr medicine that summons up more worrhy to conventional physicians than said Benjamin, who has a medicao talk show on KTAR 92.3 FM on Saturdaysz at 2 p.m. and 1,000 follower on Twitter.
“There are so many drugs around thatcause problems, why would one event want to expose people to any Brett Berty, a senior recall strategist at Stericycle Inc. in Lake Forest, is coming to Phoenix this week to meet with Matrixx officials to see if he can help the companhy withdamage control. Usually, he said, companies will voluntarily recalpl a product before the FDAgets That’s not how it happenedc with Matrixx. The FDA stepped in and warned Matrixx that it had received more than 130 consumerf complaints and that the company needed to stop marketinbg the product until it can put a warning label on its packagin that it couldcause anosmia.
Over the past 10 Berty has worked with manufacturers to conductabout 1,3090 recalls, including Vioxx. “Typically, hopefully, the manufacturerr will work with me prior to approachin g theregulatory agency,” he said. “Thd most important thing for Matrixx is you can turn a seeminglt awful situation into an opportunityif you’re judged by the publix as being part of the solution. How swiftly do they executes that will demonstrate their concern forthe public’s safety.” When the FDA sent the warnint letter to Matrixx and advised consumers not to use certain Zicam cold remedies, on June 16, Matrixx’s stocmk plummeted 70 percent to $5.7i8 a share.
It bouncede up a bit to $6.13 a day but nowhere near its 52-week high of near its trading poin t before the FDA sent thewarningf letter. For the fiscal year endec March 31, Matrixx reported $13. million in net income on $112 million in net sales, up from $10.44 million in net income on $101 million in net salea a year ago. Hemelt said he will be meeting with FDA regulatorsa to discussthe issue. He also scheduled a conference callwith

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