Household Hazards

How Everyday Products Make Us Sick
Dr. Paul D. Blanc MD MSPH is Professor of Medicine and Endowed Chair in Occupational and Environmental Medicine at the University of California San Francisco. See full bio

Does it pass the smell test?

Zinc cold remedies flunk the smell test

On June 16 2009, the U.S. Food and Drug Administration (FDA) FedEx'd a warning letter to Matrixx Initiatives, Inc concerning a new homeopathic hazard (www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm166909.htm). The FDA rarely concerns itself with homeopathic over-the counter products, but this case involved a heavily promoted and very widely used class of cold remedies.

The corporate name Matrixx may ring hollow to most consumers, but its business alias, Zicam LLC, has a far deeper resonance. The Zicam line of products (including Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs, Kids Size) is based on one key substance: zinc gluconate (labeled on its packaging as a homeopathic ingredient, zincum gluconium 2x).

The problem with zinc gluconate, by whatever name, is its strong link to an acute loss of the ability to sense smells. This can occur when, used as directed, it is applied to the nose; in many cases the injury is permanent. This can have a profound impairment on quality of life, particularly because an intact sense of smell is strongly linked to the ability to taste.

Loss of smell can occur after head trauma or as a complication of nasal or sinus infections, including viral illnesses. Chemical toxicity can be another cause. I once evaluated the owner-operator of a fish-processing plant who had been overcome at work by a concentrated ammonia leak from an industrial refrigeration system. His sensory loss improved over time, but he complained of no longer being able to recognize many familiar smells, such as his wife's perfume or freshly mown grass.

Zinc is an interesting substance, one of a group of metallic elements that are necessary nutritional factors for normal bodily functioning. This does not mean, however, that zinc is benign. Although too little may be detrimental, too much can be hazardous, too and, depending on the form of the metal and the route by which it enters the body, differing untoward effects can occur.

What about zinc gluconate, especially if applied to the nose - might a toxic loss of smell have been anticipated? Sadly, the answer is yes. In the late 1930s, zinc sulfate was touted a preventive treatment for a viral infection far more sinister that than common cold - poliomyelitis. Known then as the Peet-Schultz nasal spray, zinc sulfate was purported to protect again this dreaded disease. In the Fall of 1937, Time Magazine went so far as to speculate,"...This promises to be a light year for infantile paralysis. How much this may be due to the preventive effect of the Peet-Schultz nasal spray is any epidemiologist's guess." By 1938 though, a brief but convincing scientific report in the Journal of Pediatrics documented that loss of both taste and smell was unacceptably common among children who had received zinc sulfate nasal treatments. Such prophylaxis (which in any event was of unclear efficacy) soon fell into disfavor.

Based on this experience, nasally-applied zinc gluconate should have raised legitimate concerns before it was ever marketed in the first place. Then, as might have been feared, by 2004 a medical report of impaired smell in 10 patients due to nasal zinc gluconate appeared in a peer-reviewed journal; less than two years later, a more detailed series of 17 additional patients seen at a different medical center was documented in another medical journal.

The FDA has documented 130 cases of loss of smell over almost a decade of accumulating injury; it believes that Zicam has had more than 800 such reports of its own. The FDA has demanded that details of these be turned over the agency. For a licensed drug, this would have been automatic. But as "homeopathic" agents, the Zicam product line has avoided this as well as a series of other requirements related to medication safety, effectiveness, and labeling. In tackling the long smoldering case of nasal zinc gluconate, the FDA may be sending an important signal that its oversight may be intensified for a wide range of over-the-counter treatments, including supposedly "natural" cures of various stripes and colors. It's about time.

 



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