Putting zinc up your nose doesn’t seem like a good idea. It isn’t, says the Food and Drug Administration. June 16, 2009, the agency told consumers to cease using and pitch three zinc-containing Zicam intranasal products.
Since the debut of Zicam Cold Remedy Nasal Gel in 1999, the FDA has received more than 130 complaints of anosmia (loss of sense of smell) associated with the following:
~Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
~Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
~Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)
**Kids size has been discontinued
Some users lost their sense of smell immediately while others said it occurred after repeated applications of the zinc-contained product. Regardless, anosmia is an alarming, impairing condition that could result in permanent loss of not only smell, but taste (ageusia) also.
Not being able to fully appreciate a gourmet meal is unfortunate but the inability to smell smoke or a gas leak could prove deadly. The FDA is especially concerned with children who might not communicate their loss of smell to adults, thus possibly putting themselves in a perilous situation.
In the culinary arena, smell and taste are imperative. Imagine your favorite restaurant’s chef lacking these abilities. The ramification of spoiled food is disgusting and dangerous.
Zicam’s zinc-containing oral cold remedies are not included in the FDA warning. Apparently, anosmia seems to be solely related to the intranasal types, which can cause burning or stinging in the nose. There are also a host of other Zicam brands—about 17—that are not involved at this time.
Assessing blame is a favorite American pastime. Matrixx Initiatives, makers of the three affected products, said these items reduced the duration and severity of colds although this has not been proven. Most similar companies boast the same claims.
The FDA sent Matrixx a warning letter advising them that these products cannot be marketed without FDA approval and that they do not include adequate warnings about risk of losing one’s sense of smell.
“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the agency’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance.
Interestingly, the FDA was previously aware of scientific research linking the connection between intranasal zinc and anosmia. Should they have issued a consumer warning sooner? Perhaps.
But the public also has an obligation not to assume everything they hear, see, or read is true. Colds are a miserable nuisance but they run their course without ingesting a pill or putting a zinc product up the nose.
Report adverse side effects related to Zicam to the FDA’s MedWatch Adverse Event Reporting program online, fax (800-FDA-0178) or phone (800-FDA-1088).