Zicam Zinc Nasal Sprays May Damage Sense of Smell, FDA Says
Federal health officials warned manufacturers to cease marketing the products.
WASHINGTON, D.C., June 16, 2009— -- When 45-year-old Mary Ann Brandon of Tyler, Texas, felt a cold coming on two years ago, she reached for a treatment she had never tried before -- Zicam nasal spray.
"I used one squirt in each side of my nose," said Brandon, noting that she used the product on the recommendation of a friend.
But rather than relief from her symptoms, Brandon said, she experienced excruciating pain.
"Within 30 minutes my husband and I were headed to the hospital," she recalled. "It burned my whole face, neck. I felt like I was on fire."
While she was able to reach the hospital for treatment for her reaction to the product,she says she was met with another bizarre side effect that has continued to this day.
"I got up the next day, ate, and could not taste a thing," she said. "It took about two weeks for the burning to go away. I had no taste or smell."
The U.S. Food and Drug Administration today warned consumers to stop using three Zicam intranasal cold remedy products containing zinc after continuing reports that some users have lost their sense of smell -- a condition known as anosmia.
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The over-the-counter products are:
The FDA has received more than 130 reports of anosmia from patients who used zinc-containing nasal products, said Dr. Charles Lee, medical officer at the FDA's Center for Drug Evaluation and Research.
The agency also issued a warning letter to Scottsdale, Ariz.-based drug maker Matrixx Initiatives Inc. to stop marketing the products and seek FDA approval if it wants to keep them on the market.
Matrixx issued a statement on the FDA's action on Tuesday afternoon. "[T]he company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products," the statement reads. "Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data."
Regardless of the cause, anosmia can be more serious a problem that it sounds.
"The loss of sense of smell is serious," Lee said at a press briefing.
He said the loss of sense of smell "is potentially life-threatening and it may be permanent."
"People without the sense of smell may not be able to detect dangers, such as gas leaks or something burning in the house and may not be able to tell if food is spoiled before eating," said Deborah Autor, director of the office of compliance at the Center for Drug Evaluation and Research. "People who cannot smell are also not able to appreciate flavors and could lose much of the pleasure of eating, adversely impacting their quality of life."
Katie Rhodes, 39, said she is one of those people. Rhodes said she used Zicam just once and lost her sense of smell. She said getting used to the change was a major adjustment.
"Socially, it was harder to interact," she said. "I couldn't enjoy food. I couldn't enjoy wine. Also, one of the things I most miss was I couldn't smell my children. I had to have my five-year old open the milk for me, or smell the milk for me to see if it was off."