RN

Zicam Alert: FDA Recalls Popular Cold Remedy

Americans have been battling with the common cold for generations, seeking a remedy that alleviates the symptoms and shortens the duration of the virus. Zicam, was designed to be just that—an over-the-counter remedy, introduced in a nasal spray, that would relieve symptoms associated with colds and influenza. Manufactured and marketed by Mattrix Initiatives as a homeopathic remedy, Zicam quickly became a popular choice for anyone suffering with sneezes, coughs and a runny nose.

As early as 2003, however, reports were released that Zicam’s intranasal products caused an extensive and severe burning sensation in the nose, with a resultant loss of smell after a short period of time (hours to days). Most affected people experienced a total loss of smell, with little or no return in their smell function. There was no warning of this possible side effect on the product labels.

The mechanism responsible for these alterations in smell function is  the active ingredient in Zicam, which is zinc.gluconate. While zinc is critical for maintenance of normal smell function through its action as a cofactor in carbonic anhydrase VI, when administered directly into the nostrils at high concentrations, it can initiate direct toxic destruction of the olfactory epithelium with which it comes into contact in its spray form.

The associated nasal burning is another manifestation of this local toxicity. In previous animal studies, direct insertion of zinc into the nostrils initiated total loss of smell function. Examination of the olfactory epithelium in these animals after zinc application showed destruction of this tissue. In animals, some regeneration of the olfactory epithelium occurs over time with some return of smell function. However, mice and rats are quite different from humans, and the question of return of smell function after Zicam use in humans remains unanswered.

On June 16, 2009, the U.S. Food and Drug Administration (FDA) alerted consumers and members of the healthcare community to discontinue the use of three Zicam Cold Remedy products. In the FDA’s warning letter, they also warned the makers of Zicam to stop selling the defective products. In response to the warning, Matrixx recalled Zicam Cold Remedy Gel Swabs, both the adult and children’s versions, and Zicam Cold Remedy Nasal Gel.

The FDA warning was based on more than 130 consumer reports of anosmia (a condition marked by a total loss of smell) linked to Zicam use. In most cases, anosmia is a permanent condition that can also affect one’s ability to taste. 

In addition to the reports received by the FDA, there have been a significant number of people who claim to have suffered from anosmia following their Zicam use. In fact, 340 Zicam lawsuits were filed and settled in 2006, all of which involved cases of anosmia.

Despite the FDA’s warning letter, Matrixx still stands by its products. The company posted a letter on their web site noting that the company plans to meet with the FDA to “vigorously defend its scientific data.” Meanwhile, they are complying with the FDA and have withdrawn the suspicious Zicam swabs and nasal gel products.

The FDA has also asked that consumers and healthcare professionals report all cases of anosmia, to the FDA’s MedWatch program. You may contact MedWatch by phone at 1-800-FDA-1088 or on the MedWatch website: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm.