FDA Confirms CALL7 Investigation Of Zicam
FDA: Nasal Spray May Damage Nerves In Nose
Tom Burke and John Ferrugia , 7NEWS Investigators
thedenverchannel.com
POSTED: 11:48 am MDT June 16, 2009
UPDATED: 2:03 pm MDT June 16, 2009
DENVER -- In February, 2004 CALL7 Investigator John Ferrugia began investigating Zicam after a KMGH employee said she had lost her sense of smell after using it. The Food and Drug Administration began its own investigation of complaints from around the country and is now warning consumers that Zicam nasal spray can permanently damage users’ sense of smell.
The FDA said consumers should stop using Zicam Cold Remedy nasal gel and related products immediately.
The FDA said about 130 consumers reported a loss of smell after using Zicam, since 1999.
KMGH employee Linda Bayley was one of them.
In 2004, doctors at the University of Colorado Center for Taste and Smell Disorders told Bayley it was not likely she will get her sense of smell back.
"You just do not have enough receptor cells to know what you are smelling," Dr. Miriam Linschoten told Bayley.
"You know, looking at your whole life and not being able to smell and not being able to have flavors, all because you used a product. I mean, it's just not fair, it's just not fair," Bayley said, sobbing.
Bayley and other consumers around the country claim that product is Zicam gel, which contains zinc gluconate and is applied in the nose.
At the time, Bayley was one of more than a dozen patients Dr. Bruce Jafek has either examined personally or referred to others when they reported the loss of smell after using Zicam Intranasal Zinc.
"At least in the majority of the patients we have seen, there hasn't been a return of function," Jafek said in 2004.
Jafek says Bayley's experience with Zicam mirrored the stories of others who have used the Zicam compound and lost their sense of smell.
"I put it up my nose, like you are supposed to ... you don't inhale it, and you are supposed to hold your nostril closed ... and the burning," Bayley said. "I had the most intense burning sensation that was just ... I mean, it threw me for a loop, it was so bad." The next day, as she picked up her cat, she realized she had a serious problem. "I was cleaning her cat box and I realized I couldn't smell. I couldn't smell the cat box," Bayley said.
And then she couldn't smell her favorite food -- pumpkin pie.
"When I ate a piece I couldn't taste it. It was just bland mush," Bayley said.
Jafek says the problems of zinc compounds used in the nose are well-known -- they began in the 1930s when people were trying to prevent polio.
"It did not work for polio but was found that about 10 percent of the people lost their sense of smell as a result of the zinc application ... permanently," Jafek said in 2004.
"Closer to the present day, then it has been used in animal experiments, particularly in fish and rodents, mice and rats, in which the purpose was to put zinc into the nose and destroy the sense of smell."
But in those cases, a compound of zinc sulfate is used. Zicam contains zinc gluconate. The manufacturer, Matrixx Initiatives, says there is a significant difference in the compounds.
"Not in my mind. The idea in terms of the zinc treatment of a cold is that you want to get the zinc ion into the nose where it will have anti-viral activity," Jafek said.
In 2004, Matrixx declined an on-camera interview but told Ferrugia in an e-mail: "Statements alleging that intranasal Zicam products cause anosmia (loss of smell) are completely unfounded and misleading."
The company says, "The safety and efficacy of zinc gluconate for the treatment of symptoms related to the common cold have been well established in two double-blind, placebo-controlled, randomized clinical trials."
It also noted, "A multitude of environmental and biologic influences are known to affect the sense of smell."
In June, 2009, as a response to the completed FDA investigation, Matrixx Initiatives pointed out on its website that “No plaintiff has ever won a court case, because there is no known casual link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”
In 2004, both Jafek and Linschoten examined the company's studies and say they simply do not address the safety question.
"Since they didn't test for smell loss before and after, no (these studies) are not relevant," Linschoten said.
"There's no doubt in my mind there's a cause and effect just because I took it, it burned like crazy, the next day I didn't have any sense of smell," Bayley said.
For Bayley, the thought has brought anger, frustration, and an emotional sense of loss. "You know, the people who are closest to you, your family, it's not something you think about, but being able to smell them -- my little infant, my baby cousin. I can't smell babies anymore," Bayley said. "That human closeness. It's a connection. It's a connection lost."
Zicam makes several products and those in question by FDA are the Nasal Gel and/or Remedy Nasal Swabs including the Kids Size which has been discontinued. This does not apply to lozenges or other Zicam products.
In addition to the FDA investigation of complaints, there have now been a number of lawsuits filed against the maker of Zicam. The company has denied liability, but CALL7 Investigators found the company did settle with more than 300 consumers in 2006, for a total of about $12 million. |
