Zicam Maker Says FDA Should Reverse Warning

Matrixx Initiatives, the manufacturer of the homeopathic Zicam Cold Remedy nasal spray, has asked the FDA to reverse its ruling in June of this year concerning the adverse affects of the product. Matrixx claims that the Zicam nasal spray gels are effective and safe in spite of at least 130 FDA reports of users suffering from anosmia (loss of the sense of smell). The FDA has so far rejected the request noting that the company had received an additional 800 reports of a loss of smell after using the product. These adverse events were never reported to the FDA, as required by law.
Zicam lawsuits are mounting. In October, U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam lawsuits for pretrial proceedings in the District of Arizona. The consolidated lawsuits have similar fact patterns including that zinc gluconate, the active ingredient in the Zicam nasal sprays, is toxic to the nasal tissues and can lead to a permanent loss of the sense of smell.