Zicam Cold Remedies Recall Possible, Company Says

It hasn’t happened yet, but don’t rule out in the near future a nationwide recall of Zicam Cold Remedy products, which the Food and Drug Administration warns have caused more than 130 users to lose their sense of smell.

The FDA yesterday ordered Matrixx Initiatives Inc., the Arizona-based maker of the popular nasal cold remedies, to stop selling Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swab products until the FDA can evaluate the drugs.

The products are considered homeopathic and, as such, they never were forced to undergo stringent FDA testing to determine their safety and efficacy before they were sold. The FDA has asked Matrixx to submit a new-drug application for the Zicam products and said in the future, the products’ labeling must carry warnings about the risk of loss of the sense of smell. Until then, the products will be pulled from shelves.

More Than 100 Injuries Reported

According to the FDA, since 1999, at least 130 people have reported losing their sense of smell – also called anosmia – after using Zicam-brand cold remedies.

The FDA action on selected Zicam cold remedies is not a formal recall and technically speaking, the agency cannot order companies to recall products. Drug safety regulators may only ask companies to recall suspect products, and most often, companies agree to do so.

Recall May be in the Works

However, in a statement issued shortly after the FDA warning, Matrixx stood behind its controversial cold remedies but indicated it may announce a recall in the coming days.

“The company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace,” the company statement said.

According to Matrixx, the Zicam products targeted by the FDA warning made up about 40 percent of the company’s 2009 net sales. Matrixx reported $13.8 million in net income on $112 million in net sales in the last fiscal year, which was a solid increase from $10.4 million in net income on $101 million in net sales the previous year.

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