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 Meanwhile, they are complying with the FDA and have withdrawn the suspicious Zicam swabs and nasal gel products.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.
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