The U.S. Food & Drug Administration (FDA) issued a Public Health Advisory today to alert consumers to a possible link between Zicam nasally administered cold remedies and permanent loss of the sense of smell. According to the release, the affected products contain Zinc.
Affected products are:
- Zicam Cold Remedy Nasal Gel (15ml, NDC 62750-003-10)
- Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
- Zicam Cold Remedy Swabs, Kid Size (20 swabs, NDC 67250-003-21)
The last product has already been discontinued by the manufacturer, but consumers may still have it in their home. According to the advisory, all of these products have been associated with a long-lasting or permanent loss of the sense of smell, known as anosmia.
The products, sold over the counter in pharmacies, other retail stores and on the Internet are zinc-containing nasal cold remedies marketed as beneficial for reducing the duration and severity of cold symptoms. However, the FDA said these products have not been shown to be effective in these areas.
Additionally, since the introduction of Zicam Cold Remedy Nasal Gel to the market in 1999, the FDA has received more than 130 reports of anosmia associated with the use of Zicam zinc-containing intranasal products. Consumers report the loss of smell may occur with the first dose of the product. The FDA is especially concerned about children treated with these products, as they may be less likely to communicate the condition.
The FDA recommends that consumers stop using and discard or return the affected products. The agency also sent a warning letter to Matrixx Initiatives, which markets the products, advising the firm that these products cannot be marketed without FDA approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.
Consumers are urged to alert their physician if they experience any loss of sense of smell or other problems after using any zinc containing products administered into the nose. This advisory does not concern oral zinc tables and lozenges taken by mouth.
The FDA also is asking consumers to report any possible cases of loss of sense of smell or other problems after the use of these products through its MedWatch program, either online or by phone at 1-800-FDA-1088.
For more information, visit the FDA Consumer Updates page.