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Zicam® Drug

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FDA Warning Letter about Zicam® and Loss of Smell

On June 16, 2009, the U.S. Food and Drug Administration (FDA) sent a warning letter to the makers of Zicam® — Arizona-based Matrixx Initiatives — noting that the FDA had received over 130 reports of anosmia due to Zicam® use since the introduction of "Zicam® Cold Remedy Nasal Gel" to the U.S. market in 1999. The FDA's letter also told Matrix that its Zicam® Cold Remedy intranasal products are "misbranded" because the products' labeling does not have sufficient warning about the risk of anosmia associated with the product.

The FDA's recent actions include a consumer alert describing the risk of anosmia (total loss of smell) and hyposmia (reduced ability to smell) due to Zicam®.

A Tougher New FDA

The warning letter followed the appointment of a new FDA Commissioner, Dr. Margaret Hamburg, by President Obama. The FDA had been aware of the Zicam®/anosmia connection during the Bush administrations but took no action at that time, even though Matrixx settled about 340 Zicam® lawsuits in 2006.

In fact, according to Deborah Autor, the Director of the Office of Compliance of the FDA's Center for Drug Evaluation and Research, Matrixx received over 800 reports of hyposmia and anosmia related to Zicam® use but did not pass along these reports to the FDA.

To Be Regulated Now by the FDA?

Zicam® has not been regulated in the past by the FDA because Matrixx markets Zicam® as a "homeopathic" product. However, according to the FDA's letter, since Matrixx states that Zicam® products "reduce the duration of the common cold" and reduce "the severity of cold symptoms" such as sore throat, stuffy nose, sneezing, coughing and congestion, Zicam® products are drugs intended for use in the cure or treatment of disease.

June 2009 Recall of Zicam® Products

Although Matrixx initially refused to recall its Zicam® products when the FDA warning letter was issued (and such a refusal is very rare), it announced a recall after all, adding that customers who had purchased Zicam® would be reimbursed.

The sales of Zicam® provided Matrixx with $40 million in 2008, although the various Zicam® products have no proven benefit or effect on cold symptoms. Its main ingredient is zinc gluconium, which Matrixx maintains "treats the cold at its source — in the nose." Other ingredients are:

• benzalkonium chloride
• glycerin
• hydroxyethylcellulose
• purified water
• sodium chloride
• sodium hydroxide

Learn More about the Zicam® Recall

If you're concerned about the risks presented by Zicam® cold remedy products, contact a Zicam® lawyer in your area that represents individuals who have been harmed by this product.