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Zicam maker begins voluntary recall – July 15, 2009

The Food and Drug Administration has ordered Matrixx Initiatives, Inc. of Scottsdale, Arizona to stop the marketing of zinc-based Zicam cold products because of concerns that the internasal products may damage the sense of smell. The products listed are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size.

The action was based on the receipt by the agency of over 130 reports from doctors and consumers of the loss of the sense of smell, known as anosmia, associated with use of the products. It is believed that an additional 800 reports have been made directly to the company. Companies are required by law to forward these types of reports to the FDA, but they have not as yet been received by the agency.

Dr. Charles E. Lee of the agency’s compliance office noted that animal studies have demonstrated that zinc damages nerve receptors in nasal passages, which can lead to anosmia. Deborah M. Autor, director of the office of compliance for the FDA’s Center for Drug Education and Research stated that “the damage can be temporary or permanent.”

Should Matrixx Initiatives wish to market the product in the future, the FDA is requiring approval just as it does for prescription drugs. Zicam had not initially required such approval and was treated as an over-the-counter supplement. Matrixx has emailed a statement saying that it would cooperate fully with the FDA and has begun a voluntary recall to cooperate with the FDA.  Matrix “vigorously disagrees” with the Food and Drug Administration that the product is unsafe and will seek a meeting with the FDA to review the product safety data.

If you have lost your sense of smell after using a Zicam product, do not discard or return the product as the FDA suggests, as it may become evidence that may be needed in a legal proceeding. Store the product safely in a manner in which it will no longer be used, until you contact an attorney.

 

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