The FDA is refusing to reverse a warning about loss of smell from Zicam, which led to a recall last summer for the over-the-counter cold remedy’s nasal sprays and gels.
According to a regulatory filing with the Securities Exchange Commission (SEC) filed by Matrixx Initiatives, Inc., the makers of Zicam, the FDA is standing by their position that zinc-based Zicam nasal sprays and gels put users at risk for losing their smell, a condition known as anosmia. The FDA reaffirmed their position after Matrixx filed a response in November 2009 to the original warning letter.
On June 15, 2009, the FDA recommended that consumers stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size after the agency identified at least 120 reports of people who lost their sense of smell. Within hours of the warning, Matrixx Initiatives issued a Zicam recall.
In the aftermath of the recall, FDA inspectors discovered 800 reports of Zicam problems that Matrixx Initiatives failed to forward to the agency, in violation of federal regulations.
At the time of the recall for Zicam, the FDA indicated that Matrixx Initiatives would not be permitted to market the cold remedy until they submit data establishing that they are safe and effective. Zicam was not approved by the FDA when it was first introduced, as it was classified as a homeopathic product, which is a designation usually reserved for herbal remedies. However, once the health concern was identified, the FDA was able to force the company to have the product approved, regardless of classification.
The company has twice asked the FDA to retract the warning, most recently in November, saying that they do not believe the products pose a danger. The FDA has refused both times. Matrixx Initiatives officials say they are weighing their remaining options.
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. The company also faces lawsuits from investors who say that the company falsely represented its products by hiding the anosmia complaints. The SEC is also investigating the company’s actions.
In October, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal Zicam litigation for pretrial proceedings in the District of Arizona. 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.