ZICAM

Reuters and Associate Press report that U.S. regulators warned Matrixx Initiatives to stop selling intranasal versions of its zinc-containing Zicam® cold remedy after more than 130 reports of people losing their sense of smell after using the products. The U.S. Food and Drug Administration also urged consumers to stop taking the over-the-counter products. The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs. "Loss of the sense of smell is potentially life threatening and may be permanent," said Dr. Charles Lee. "People without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house."

Health officials said 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 Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer. The "FDA doesn't take action against drug products without evaluating all of the circumstances surrounding the issues with the product," Lee said.

The company must seek FDA approval if it wants to continue selling the Zicam zinc products that are administered through the nose, agency officials said.

The FDA warning applies to Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. A public health advisory posted on the FDA website said the products "have all been associated with long lasting or permanent loss of smell" and "have not been shown to be effective in the reduction of the duration and severity of cold symptoms." The action does not affect Zicam oral zinc tablets or lozenges, the FDA said.

Ury & Moskow is currently reviewing potential cases where patients experienced significant loss of smell after using Zicam. If you think you or a loved one may have suffered a serious loss of smell following Zicam use, you should speak with an attorney to see if you have a case and to discuss the possibility of bringing a lawsuit for money damages. Your attorneys can determine if you have a claim for which a lawsuit can be pursued. Please contact the law firm of Ury & Moskow to discuss your potential claim with an experienced pharmaceutical lawyer.