The Food and Drug Administration (FDA) has advised consumers to stop using certain Zicam nasal cold remedy products, saying they can cause users to lose their sense of smell permanently.
The over-the-counter products, made and marketed by Scottsdale-based Matrixx Initiatives Inc., contain zinc, an ingredient that can damage nerves in the nose needed for smell, agency officials said.
AdvertisementThe other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.
The warning comes after the FDA received more than 130 consumer complaints about some of Matrixx's most popular products, including Zicam Cold Remedy Nasal Swabs and a no-drip nasal spray called Zicam Cold Remedy Nasal Gel.
"Loss of the sense of smell is potentially life threatening and may be permanent. People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house," CBS News quoted Dr. Charles Lee, of FDA's compliance division, as saying.
Matrixx defended the safety of its products, but said it may remove them from the market.
The FDA said that Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching.
The agency never fully regulated these products, because they were considered homeopathic treatments.
Now, a warning letter issued to Matrixx on Tuesday has asked the company to stop marketing its zinc-based products and submit safety data on the drug.
Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: "No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell."
The company said in a statement that the safety of Zicam Cold Remedy is "supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists."
However, government scientists say they are not aware of any data supporting Zicam's labelling, which claims the drug reduces cold symptoms, including "sore throat, stuffy nose, sneezing, coughing and congestion."