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

goldenayreyg1666.blogspot.com
The FDA said it received more than 130 complaintss from consumers saying they have lost theire sense of smell after usinythe products. Jennifer Warren, a formerd school teacher who livesin Huntsville, Ala., said she lost her sense of smell after using Zicam to prevent the duration of a cold a few yearsw ago, but had never complainedf to the FDA or the company because she figure d there was no way to provew Zicam caused her anosmia. She said she doesn’gt want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even aftedr 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 aboutr all these drugs not beinbg allowed onthe market. The firstf time anything goes wrong, everybody wants to go sue, sue, sue. That drivese me nuts. I honestly believe the people were tryinb to do something to help people not get William Hemelt, acting president and chiefv operating officer of Matrixx, said the FDA actio n was taken without reviewing researchn he would have been more than willing to provide. “We thinkl the science does not support this allegationhat all,” he said. “Quiter honestly, we would not be selling the producft if we thought itwas unsafe.
” Zican products use a homeopathic remedy calledc Zincum Gluconicum 2x, which means they requirr FDA approval. Dr. Sam a medical doctor with a homeopathic license, said he can’g figure out why the FDA has taken so long to deal withthe issue. “oI can think of no part of alternative medicinde that summons up more worry to conventional physiciansthan homeopathy,” said who has a medical talk show on KTAR 92.3 FM on Saturdaysz at 2 p.m. and 1,0009 followers on Twitter. “There are so many drugs around thatcause problems, why would one event want to exposr people to any danger.” Brett Berty, a senior recall strategisyt at Stericycle Inc. in Lake Forest, Ill.
, is cominfg to Phoenix this week to meet with Matrixx official to see if he can help the company withdamagw control. Usually, he said, companiex will voluntarily recall a producrt before the FDAgets involved. That’s not how it happenedd with Matrixx. The FDA stepped in and warned Matrixsx that it had received more than 130 consumer complaintx and that the company needed to stop marketing the product unti l it can put a warning label on its packaging that it couldecause anosmia. Over the past 10 Berty has worked with manufacturers to conductabouyt 1,300 recalls, including Vioxx.
“Typically, the manufacturer will work with me prior to approaching theregulatory agency,” he “The most important thing for Matrixz is you can turn a seemingly awfu l situation into an opportunity if you’r judged by the public as being part of the solution. How swiftlyt do they execute that will demonstrated their concern forthe public’z safety.” When the FDA sent the warning letter to Matrixzx and advised consumers not to use certain Zicajm cold remedies, on June 16, Matrixx’ s stock plummeted 70 percent to $5.78 a share. It bounced up a bit to $6.1w a day later, but nowhere near its 52-weekk high of $19.
74, near its tradintg point before the FDA sent the warning For the fiscal year endedMarcy 31, Matrixx reported $13.8 million in net incomd on $112 million in net sales, up from $10.4 million in net income on $101 millioj in net sales a year ago. Hemelr said he will be meeting with FDA regulators to discusxsthe issue. He also scheduled a conferencd callwith investors.