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FDA Warns to Discontinue Use Zicam

Explaining the Cases

Zicam is a popular non-prescription zinc nasal spray. Its manufacturer markets it as a medication to shorten the duration of the common cold. Zicam has been associated with the onset of a condition known as anosmia, which leaves the user with a potentially permanent loss of smell and taste. These side effects typically are irreversible. The federal Food and Drug Administration (FDA) currently is collecting and evaluating reports of severe reactions to Zicam.

Zicam Manufacturer Describes Reports of Anosmia as “Completely Unfounded”

Although there are widespread reports of potential problems with the medication, the manufacturer of Zicam refuses to warn users about the possible dangers of the drug. Matrixx Initiatives, the manufacturer of Zicam, reported on their web site that the medication is “safe” even though there is an admission that they had not conducted any studies on the loss of smell.

The manufacturer of Zicam went even further when it released a notice on February 6, 2004 “reaffirming” the safety of Zicam. The manufacturer claimed:

Reports alleging anosmia—or loss of smell—in a small number of patients using zinc gluconate intranasal gels for the treatment of the common cold are completely unfounded and misleading.

These safety notices issued by Matrixx were made even though the company admitted it had not conducted any studies on loss of smell and in the face of numerous user reports and news stories linking the nasal spray with anosmia.

More recently, on June 16, 2009, the FDA advised consumers to discontinue use of several Zicam Cold Remedy products due to the risk of anosmia, a potentially permanent loss of smell. Matrixx Initiatives, the manufacturer of Zicam, settled approximately 340 cases in January 2006 involving people who alleged anosmia following use of Zicam. The FDA indicated it had received complaints from 130 consumers dating back to 1999.

The FDA issued a warning letter stating the products no longer can be marketed without FDA approval. Matrixx Initiatives previously took the position that Zicam was a homeopathic drug not subject to FDA regulation.

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