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Zicam Safe, Matrixx Says, But Recall Possible

Jun 17, 2009 | Parker Waichman Alonso LLP

Matrixx Initiatives, the maker Zicam intranasal cold remedies, said in a press release yesterday that it may issue are recall of some of the products, even though it still asserts that they are safe.  The press release was issued in response to yesterday's Food & Drug Administration (FDA) warning that use of three Zicam products - Zicam Cold Remedy Nasal Gel,  Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size - could lead to  a loss of sense of smell.

According to a posting on its website, the FDA has received 130 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 agency  said it was concerned that anosmia caused by the Zicam products could be permanent.  It warned users not to use any of the three Zicam intranasal products named in the alert, and said anyone who experienced loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.

The FDA also said it sent a warning letter to Matrixx 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.

In yesterday's press release, Matrixx - as it has done for years - continued to insist Zicam intranasal cold remedies are safe and do not cause anosmia, and called the  FDA's actions "unwarranted."  The company said it was working to determine a response to the FDA "which may include removing these products from the marketplace."

Zicam,  which also comes  in melting tablet and liquid form (these varieties were not included in the FDA alert), is Matrixx Initiatives' top-selling product line, and accounts for about 40 percent of its sales.  However, there have been concerns for several years now that the nasal varieties of Zicam remedies could lead to anosmia.   

Zinc gluconate, the active ingredient 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.