Users of Zicam Nasal Cold Remedies Could Lose Sense of Smell, FDA WarnsJun 16, 2009 | Parker Waichman LLP
Consumers should not use three Zicam intranasal products because they may cause a loss of sense of smell, the Food & Drug Administration (FDA) warned today. The products affected by the FDA public health advisory 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, Kids Size (20 swabs, NDC 67250-003-21)
Zicam, which also comes in melting tablet and liquid form, is Matrixx Initiatives' top-selling product line. The melting tablet and liquid varieties of Zicam are not included in this FDA alert.
Zicam products are popular over-the-counter nasal cold remedies. Zinc gluconate, the active ingredient is in Zicam products, has long been believed to produce a caustic action on the nasal passages that, over time, can lead to a loss of smell.
According to Bloomberg.com, the FDA first received reports of a loss of smell linked to Zicam in 1999. In 2006, Matrixx agreed to pay $12 million to settle claims by 340 plaintiffs who said they lost their sense of smell after using the product.
According to the FDA, it has received130 reports of anosmia—the loss of sense of smell—associated with use of the three Zicam products covered by its alert. During a conference call to announce the Zicam alert, the FDA also said Matrixx had received an additional 800 reports it hasn’t made available to the agency. The FDA said that many people who experienced a loss of sense of smell say that the condition occurred with the first dose of Zicam, although some people have reported loss of sense of smell after later doses.
The FDA is concerned that the loss of sense of smell may be permanent. Consumers should contact their health care professional if they experience loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.
The Zicam intranasal zinc products are widely sold in pharmacies, other retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size, has already been discontinued, but the FDA is concerned that consumers may have the product in their home. The agency said it has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.
The agency is warning consumers to stop using and discard or return the Zicam zinc-containing intranasal products. The FDA sent a warning letter to Matrixx Initiatives advising the firm that these products cannot be marketed without agency approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.