Matrixx Initiatives Requests FDA Reverse Warning About Zicam Side Effects

Matrixx Initiatives has renewed a request that the FDA reverse a warning to consumers that side effects of Zicam nasal sprays and gels can cause loss of smell, and are also asking the agency to reveal how it concluded that some of their Zicam products are dangerous.

The manufacturer formally requested last week that the FDA lift a warning that resulted in a partial Zicam recall in June. The FDA rejected a similar request last month.

A Freedom of Information Act (FOIA) request was also filed by Matrixx Initiatives, asking for documentation on the FDA’s methodology and their analysis, which led the agency to issue a warning on June 15 advising consumers to stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. As a result of their review, the FDA also advised Matrixx Initiatives that they would be unable to market the product until they presented evidence establishing that the Zicam cold remedies were safe and effective.

The FDA took the regulatory action after discovering at least 130 reports involving users Zicam who developed anosmia, which involves a loss of the sense of smell. This long-lasting and permanent damage not only diminishes quality of life, but could also prevent an individual from being able to smell gas leaks, smoke, spoiled food or detect other dangerous conditions.

Subsequent inspections also revealed that Matrixx Initiatives had received about 800 more reports of Zicam problems that were never reported to the FDA as mandated by federal regulations.

Matrixx Initiatives faces a number of Zicam class action lawsuits and Zicam injury lawsuits that allege the company knew the products were dangerous and continued to market them anyway.

In October, the U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam litigation for pretrial proceedings in the District of Arizona for coordinated handling. All of the lawsuits over Zicam contain similar allegations that zinc gluconate, the single active ingredient in nasal Zicam cold remedies, is toxic to the tissue inside the nose and can cause damage to a user’s ability to smell, detect odors or taste.

Despite the reports of user problems, Matrixx Initiatives has maintained that Zicam is safe and does not cause users to suffer loss of smell or taste. Last month the company asked the FDA to rescind the Zicam anosmia warning, but the FDA rejected the request. Along with the new request issued last week, the company is now arguing that fundamental fairness requires that the FDA explain how it arrived at its conclusion that Zicam is dangerous to users sense of smell.