Zicam Users Don't Smell a Rat (And That's the Problem…)

Scottsdale, AZA recent warning from the US Food and Drug Administration (FDA) with regard to Zicam nasal spray has migrated to Canada, where the Canadian Health authority has mirrored the FDA recommendation for consumers to immediately stop using three Zicam products containing zinc, due to potential issues regarding an individual's sense of smell.

Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size, are promoted as natural, homeopathic remedies used to relieve cold symptoms and to reduce the length and severity of colds. Health Canada, in a release dated June 17th is advising consumers to immediately stop using the nasal spray due to various reports involving the temporary, or permant loss of an individual's sense of smell.

The FDA, in fact, identifies 130 adverse reaction reports from consumers with regard to the partial, or complete loss of smell. Dr. Charles E. Lee, a compliance offiver in the FDA's drug center, was quoted in the New York Times Wednesday as saying that zinc—an active ingredient in Zicam—could be toxic to nerve receptors in the nose.

Deborah M. Autor, director of compliance in the agency's drug center, is concerned that "this disabling loss of one of the five senses may be long lasting or even permanent in some people," Ms. Autor said in a statement appearing in the New York Times. "People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life."

While the FDA and Health Canada have taken action this week, the concern over zinc and its relationship with a person's sense of smell when applied nasally is hardly a new problem.

According to the FDA's Dr. Lee, intranasal zinc was tested as a polio preventative way back in the 1930s. Some patients, at that time, were found to suffer from anosmia—the scientific term for loss of smell.

More recently Matrixx Initiatives—the manufacturer of Zicam—has received more than 800 reports of Zicam users losing their sense of smell since the product(s) first appeared on the market in 1999. However, according to the FDA's Deborah Autor those reports never found their way to the FDA.

Current laws require manufacturers to provide to the FDA all reports of product-related injuries with regard to approved drugs. However the FDA would not confirm if the reporting requirement applied to Matrixx.

The requirement issue could be related to the fact that Zicam is billed as a homeopathic product. Thus, the manufacturer was not required to seek FDA approval for the product before putting it on the market.

It was revealed in the New York Times piece of June 17th that adverse reaction reports extend all the way back to 1999, when the product was first introduced.

Four years ago, in 2006 Matrixx Initiatives paid out $12 million to settle 340 lawsuits from Zicam users claiming that their use of Zicam brought about their anosmia.

The fact the FDA has responded now, in deference to the era of the former Bush Administration during which the FDA took no action against Zicam, could be indicative of the FDA getting serious. A new FDA Commissioner, Margaret A. Hamburg was named by President Obama soon after coming into office. Hamburg was quoted in the New York Times article as being of the view that Zicam "strikes us as a fairly large problem."

While the FDA has no power to actually mandate a product recall, various bills presently passing through Washington would give the FDA that power. With regard to the Zicam case, it is not known if the FDA asked Matrixx to recall the product, although the New York Times refers to Matrixx Initiatives as refusing to recall the products. What is known is that the FDA issued a product warning and Matrixx, in a news release, indicated that it had suspended all shipments of Zicam.

Matrixx indicated that it would be willing to reimburse Zicam users who sought a refund.

"Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia," the release said. "For this reason, Matrixx Initiatives believes that the FDA.action is unwarranted and will seek a meeting with the FDA to review the company's product safety data."

An FDA warning letter sent to Matrixx on Tuesday states that Zicam Cold Remedy intranasal products "may pose a serious risk to consumers who use them" and are "misbranded." The New York Times article referred to the products have no proven benefits, although it was not clear if that conclusion was contained in the FDA warning letter.

Zicam earned $40 million in sales for Matrixx in 2008, representing about 40 percent of the manufacturer's total revenue for the year. Matrixx Initiatives is based in Scottsdale, Arizona.