WASHINGTON—FDA is urging consumers not to use Zicam Cold Remedies, stating the agency has received 130 adverse event reports (AERs) since 1999 suggesting use of the zinc-based intranasal products could cause loss of smell (anosmia). AP reported Scottsdale, Ariz.-based Matrixx Initiatives is facing litigation over the products, but in the release of its fiscal 2008 figures, Matrixx asserted there is no evidence showing a causal link between its zinc nasal gel and loss of smell.
FDA also issued a warning letter to Matrixx, stating it considers the products to be unapproved new drugs and to be misbranded because they lack warnings about the possibility of anosmia. It is requesting the company take action to correct the violations within 15 days, and to also submit to FDA all anosmia-related reports the company has received, which FDA alleges to be in the range of 800 reports.
In response to INSIDER’s request for comment, Matrixx Initiatives issued the following statement: “Matrixx Initiatives confirms that it has received a warning letter from [FDA] about three of its 19 Zicam products, specifically Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs and Zicam Cold Remedy Swabs, Kids Size, based on allegations that their use could cause a temporary or permanent loss of smell, known as anosmia. Zicam Cold Remedy oral products were not included in the letter. Matrixx Initiatives’ primary concern is consumer safety. Based on the FDA’s action, the company has suspended shipments of these products and will reimburse any customer desiring a refund. However, the company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold remedy products. Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia. For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.”