Evelyn Pringle June 19, 2009
Matrixx is preparing for a new wave of lawsuits from consumers alleging that certain Zicam products have caused anosmia, or loss of smell and taste, according to the June 19, 2009 Arizona Republic.
In early 2006, the company settled one round of 340 lawsuits for $12 million to avoid the legal costs of defending each suit, company officials told the Republic.
On June 16, 2009, the FDA warned the public to stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size because they could cause "long-lasting or permanent" loss of smell.
The agency noted receiving130 reports since 1999 from consumers and doctors. The FDA learned that Matrixx had received another 800 reports during an inspection of the company in May, and claims the Matrixx was required to turn them over to the FDA under a 2007 regulation.
The agency also sent Matrixx a warning letter saying these products cannot be marketed without FDA approval. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah Autor, director of CDER’s Office of Compliance, in the advisory to the public.
"The FDA has asserted that the Company is in violation of its regulations by failing to file a new drug application for its Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs and that those products are misbranded under their regulations for failing to adequately warn of risks," Matrixx said in a June 16, 2009 press release.
"The Company believes the FDA action is unwarranted and is in the process of determining its response, which may include removing these products from the marketplace," Matrixx wrote.
"These products constituted approximately 40% of the Company's net sales in 2009," the release noted.