Upset with the U.S. Food and Drug Administration, Zicam maker Matrixx Initiatives Inc. has withdrawn two of its cold remedy nasal products even though company officials maintain the products are safe.
The FDA said it received more than 130 complaints from consumers saying they have lost their sense of smell after using the products.
Jennifer Warren, a former school teacher who lives in Huntsville, Ala., said she lost her sense of smell after using Zicam to prevent 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 prove Zicam caused her anosmia.
She said she doesn’t want to sue Scottsdale-based Matrixx (Nasdaq:MTXX) even after learning others have had the same experiences.
“I don’t think Zicam was created to hurt anyone,” she said. “We sit here and we rip and we rave about all these drugs not being allowed on the market. The first time anything goes wrong, everybody wants to go sue, sue, sue. That drives me nuts. I honestly believe the people were trying to do something to help people not get sick.”
William Hemelt, acting president and chief operating officer of Matrixx, said the FDA action was taken without reviewing research he would have been more than willing to provide.
“We think the science does not support this allegation at all,” he said. “Quite honestly, we would not be selling the product if we thought it was unsafe.”
Zicam products use a homeopathic remedy called Zincum Gluconicum 2x, which means they require FDA approval.
Dr. Sam Benjamin, a medical doctor with a homeopathic license, said he can’t figure out why the FDA has taken so long to deal with the issue.
“I can think of no part of alternative medicine that summons up more worry to conventional physicians than homeopathy,” said Benjamin, who has a medical talk show on KTAR 92.3 FM on Saturdays at 2 p.m. and 1,000 followers on Twitter. “There are so many drugs around that cause problems, why would one event want to expose people to any danger.”
Brett Berty, a senior recall strategist at Stericycle Inc. in Lake Forest, Ill., is coming to Phoenix this week to meet with Matrixx officials to see if he can help the company with damage control.
Usually, he said, companies will voluntarily recall a product before the FDA gets involved. That’s not how it happened with Matrixx. The FDA stepped in and warned Matrixx that it had received more than 130 consumer complaints and that the company needed to stop marketing the product until it can put a warning label on its packaging that it could cause anosmia.
Over the past 10 years, Berty has worked with manufacturers to conduct about 1,300 recalls, including Vioxx.
“Typically, hopefully, the manufacturer will work with me prior to approaching the regulatory agency,” he said. “The most important thing for Matrixx is you can turn a seemingly awful situation into an opportunity if you’re judged by the public as being part of the solution. How swiftly do they execute that will demonstrate their concern for the public’s safety.”
When the FDA sent the warning letter to Matrixx and advised consumers not to use certain Zicam cold remedies, on June 16, Matrixx’s stock plummeted 70 percent to $5.78 a share. It bounced up a bit to $6.13 a day later, but nowhere near its 52-week high of $19.74, near its trading point before the FDA sent the warning letter.
For the fiscal year ended March 31, Matrixx reported $13.8 million in net income on $112 million in net sales, up from $10.4 million in net income on $101 million in net sales a year ago.
Hemelt said he will be meeting with FDA regulators to discuss the issue. He also scheduled a conference call with investors.
The FDA advises against using:
