WASHINGTON, D.C. (KCBS) -- The Food and Drug Administration Tuesday warned consumers to stop using a popular cold remedy after it was found to cause some users to lose their sense of smell.
The FDA said Zicam Cold Remedy nasal gel and adult and children's Zicam Cold Remedy nasal swabs caused the troubling side effect in approximately 130 patients since 1999.
KCBS’ Melissa Culross Reports
"We have some that range out to four years after the date of onset where patients have not had return of their sense of smell," said Dr. Charles Lee with the FDA's Compliance Division.
The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell.
While the agency has not issued a formal recall, it's warned Zicam's manufacturer, Arizona-based Matrixx Initiatives, to stop marketing the products and submit safety and effectiveness data on them.
Matrixx said it will consider withdrawing the products, which accounted for about 40% pf its $111.6 million in sales last year.
Health officials say they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say whether the company broke the law.
The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.