FDA: Avoid Zicam Nasal Gels

If ever there were a cure worse than the disease, it would be an over-the-counter product marketed as relief for common-cold symptoms that instead leads to the permanent loss of your sense of smell.

The Food and Drug Administration is warning that zinc-containing products carrying the Zicam brand and that are meant to be inserted in the nose are capable of causing such a loss of smell.

An excerpt from the FDA's press release:

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:

—Zicam Cold Remedy Nasal Gel
—Zicam Cold Remedy Nasal Swabs
—Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person's quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

 

NPR's Joseph Shapiro reports that the FDA found worrisome information in the files of Matrixx Initiative, the maker of the products:

FDA inspectors went to the Zicam manufacturing facility in May. And in its files, they found more than eight hundred complaints from consumers who'd said they'd lost their sense of smell, sometimes permanently, after using the products.

The FDA said consumers should stop buying Zicam cold remedy products that are inserted into the nose. And should throw out any in their medicine cabinet.

The FDA told manufacturer Matrixx Initiatives that it needs to get FDA approval to continue selling the products. Zicam is considered a homeopathic remedy. And those are not regulated by the FDA with the same strictness applied to prescription and over-the-counter medications. But the FDA can step in when there are safety concerns.

The company did not respond to a request for comment.

This situation suggests a possible a flaw with the way the FDA approaches these over-the-counter products. Consumers are essentially unknowing guinea pigs for many of these homeopathic products which don't need initial FDA approval unless they cause harm.

That means some consumers wind up being sacrificed until the problem rises to the level where it attracts FDA attention. Many consumers would no doubt be surprised and troubled to know that's how the current system works.