
Matrixx Initiatives received a warning letter from the FDA concerning Zicam Cold Remedy Swabs and Zicam Cold Remedy Nasal Gel for adults and children amid some 130 consumer reports they may have been responsible for robbing users of their sense of smell temporarily or permanently.
Although the FDA didn't request a formal recall, the letter called for a halt to any marketing campaigns regarding Zicam and required Matrixx to submit detailed safety and effectiveness data. The big concern: These products contain zinc, a mineral linked to nasal nerve damage.
Just three years ago, the Arizona-based company settled 340 lawsuits with a hefty $12 million pricetag, based on claims the use of Zicam triggered anosmia, a condition that prevents sufferers from detecting any kind of scents in the very same way blindness is to sight, according to the Anosmia Foundation.
The FDA has also asked Matrixx for information about more than 800 consumer complaints connected to the loss of smell, thanks to a 2007 law on the books that compels companies to notify the agency as problems arise.
New York Times June 16, 2009
Orlando Sentinel.com June 17, 2009
South Florida Business Journal June 17, 2009
Zicam.com June 16, 2009
Zicam is a trademark of Matrixx Initiatives.