The FDA is warning consumers not to use several versions of Zicam Cold Remedy after receiving more than 130 reports of people losing their sense of smell. Though the action has not been termed a Zicam recall, since the homeopathic product was never formally approved by the FDA, the popular over-the-counter nasal gel and swabs will have to undergo federal review before they can be sold again in the United States.
The warning was issued today for Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. Matrixx Initiatives, the maker of Zicam products, was told that they must stop marketing the cold remedies and submit safety and effectiveness data for review.
The affected Zicam products are delivered through the nose and contain zinc, which may damage nerves in the nose and result in a loss of the sense of smell as a side effect. The condition, called anosmia, may occur as early as the first dose and can be long-lasting or permanent.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said the FDA’s Janet Woodcock, M.D. “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”
Zicam side effects have been associated with a risk of anosmia for some time, and the manufacturer, Matrixx Initiatives, has reportedly settled approximately 340 Zicam lawsuits filed by people who claim their sense of smell or taste was impacted by the cold remedy.
Zicam gel, containing zinc gluconate, is applied to the nasal cavity by spray or swab. The zinc can reduce the duration and strength of a cold, but it has also been commonly accepted that heavy use in one area of the nose can damage the sense of smell. The FDA warning on Tuesday notes that Zicam damage can occur with a single dose, however.
The 130 reports the FDA has collected since 1999, were all from physicians and consumers. The FDA received no reports from the manufacturer. A law passed in 2007 requires manufacturers to report consumer complaints and problems that indicate there may be a problem with their product. FDA officials have not said whether the company broke the law.
Zicam was not formally approved by the FDA because it was considered a homeopathic product; a marginally regulated class of over-the-counter medications which usually include natural herbs and minerals. However, because of the Zicam safety issues, the agency is now requiring formal approval before it can be sold.
“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marked for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER).
The FDA warning only indicated that three versions of Zicam were impacted, the Nasal Gel, Nasal Swabs and Kids Size Swabs. Other Zicam Cold Remedy products not currently impacted include RapidMelts, Oral Mist, Chewables, ChewCaps, Multi-Symptom Cold & Flu, Cough Spray, Cough Melts and Cold Sore Gel Swabs.