Zicam Recall: Manufacturer Says FDA Not Changing Stance on Zicam

According to Matrixx Initiatives, Inc., maker of Zicam cold remedy, the FDA is not going to reverse a prior stance that prevents the company from marketing the over-the-counter homeopathic remedy due to reports of consumers losing their sense of smell after using the nasal gel.

A Zicam recall was issued in June, after the FDA issued a warning that consumers should not use Zicam nasal gel sprays and nasal swabs, which were marketed to help reduce the duration and severity of the common cold.

Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural products. However, after identifying at least 130 cases where users lost their ability to smell after Zicam use, the FDA warned Matrixx Initiatives that they would no longer be permitted to market the products until they submit data establishing the safety and effectiveness.

According to a recent filing with the U.S. Securities and Exchange Commission (SEC), Matrixx Initiatives has failed in its efforts to get the FDA to reconsider its opinion that zinc-based Zicam products applied directly to the nose can cause loss of smell, known as anosmia.

Although Matrixx Initiatives has maintained that their product is safe and does not cause loss of smell problems, the company disclosed after the recall that they were aware of at least 800 reports of Zicam side effects that were never turned over to the FDA.

Matrixx Initiatives’ stock has tumbled since the June recall of Zicam, and it 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.

Earlier this month, 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.

In addition to the damage loss of smell or taste can have on an individual’s quality of life, it could also increase the risk of life-threatening injuries if someone is unable to smell dangerous fumes, smoke or food that has gone bad.