Hundreds of Americans are thought to be at risk of permanent loss of smell after taking particular homeopathic remedies that contain zinc and are marketed under the brand name, Zicam.  Because anosmia, the medical term for loss of smell, can be ‘potentially life-threatening,’ the US Food and Drug Administration (FDA) has issued a warning to consumers urging them to avoid using these products and it’s also issued a warning to Matrixx Initiatives, Inc., the Scottsdale, Arizona, manufacturer of Zicam products.  The Matrixx letter asks the drug maker to stop selling the products until they are granted FDA approval.

The three products in question are:

• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Nasal Swabs
• Zicam Cold Remedy Swabs, Kids Size

All three products are sold over the counter (OTC), without need for a physician’s prescription, and they are all used directly in the nose.  The Kids Size formula has been discontinued but consumers may still have some of these swabs in their medicine cabinets.  The FDA has asked that neither of these products be used.

Dr. Charles Lee serves as a medical officer for the FDA Center for Drug Evaluation and Research.  In a press briefing, he described the effects of anosmia as ‘particularly dangerous’ because patients suffering from this condition cannot detect smells that signal danger, such as smoke, gas leaks, and spoiled foods.

Lee acknowledged the 130 cases of anosmia reported to the FDA is small, given the overall population, but such complaints are typically filed with the manufacturer, not the FDA.  He also said that, until 2007, reports of adverse events filed with OTC drug manufacturers did not have to be forwarded to the FDA.

The agency began getting reports of adverse events involving Zicam’s zinc-containing products in 1999 but most such reports have been filed since 2004.  In 2006, Matrixx made settlement payments totaling $12 million in response to 340 consumer lawsuits, each of which claimed the zinc nasal gel caused problems with plaintiffs’ sense of smell.

The FDA letter to Matrixx asks the manufacturer to release more than 800 reports pertaining to loss of smell associated with these products.  It also gives the manufacturer a 15-day period to cease marketing of these products and to devise a plan for removing all previously distributed products from store shelves.

A substantial body of medical information confirms applying zinc directly on nasal tissue, as these three products are meant to be used, is toxic to nerve receptors.  Damage to these nerve receptors can result in permanent loss of the sense of smell.  If Matrixx wants to resume selling these products at a later date, it must first obtain FDA approval to do so.