Zicam - Safety Concerns - FDA Warning and Product Recall

FDA Warning and Product Recall

On June 16, 2009, the FDA advised consumers to discontinue use of three nasally administered versions of Zicam Cold Remedy—Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (a discontinued product)—because the FDA had associated a serious risk of anosmia with them. The advisory did not implicate other Zicam products. The FDA indicated that it had received reports of a loss of smell from approximately 130 Zicam Cold Remedy users since 1999. The FDA voiced concern that the loss of smell may be long-lasting or permanent, while the condition for which these Zicam products are marketed—the common cold—typically resolves on its own without lasting problems. The manufacturer stated that it had received an additional 800 reports of a loss of smell, but did not turn those over to the FDA as they did not feel they were required to do so. The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam Cold Remedy.

The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval. The company initially refused to recall the products but later said that they would withdraw the products from sale and that, "based on the FDA’s recommendation, consumers should discard any unused product or contact Zicam ... to request a refund." On June 24, 2009, Matrixx recalled all affected products. The company maintained that most cases of anosmia are due to the common cold itself, and that complaints of anosmia among Zicam Cold Remedy users are unlikely to be more numerous than those expected among the general population. In contrast, the FDA had reported that cases of anosmia associated with intranasal Zicam Cold Remedy products were in excess of those seen with other nasal remedies for the common cold, and that cases associated with intranasal zinc presented more rapidly, and with different symptoms, than did unrelated cases.

In addition, the FDA's warning letter prompted the Securities and Exchange Commission to investigate the company. Through Freedom of Information Act (FOIA) filings, Matrixx has requested the FDA to provide the research and evidence that led them to request the withdrawal of Zicam swabs. The company said that "fundamental fairness" required a clear explanation of the FDA's methodology and analysis.

On June 19, 2009 Health Canada, in a foreign product alert, also issued a similar warning based on the U.S. FDA information.