Zicam Cold Remedy Gets FDA Warning; Matrixx Dives (Update3)
By Shannon Pettypiece
June 16 (Bloomberg) -- Zicam nasal sprays and swabs made by Matrixx Initiatives Inc. may cause permanent loss of smell and taste and people should stop using them, U.S. regulators said, and the company plunged the most in trading since its initial public offering.
Matrixx, based in Scottsdale, Arizona, fell $13.46, or 70 percent, to $5.78 at 4:30 p.m. New York time in Nasdaq Stock Market composite trading. That’s the biggest percentage decline in one day since the IPO in April 1996.
The Food and Drug Administration has received more than 130 reports of people losing their sense of smell after using zinc- based Zicam nasal spray and swabs, and Matrixx has an additional 800 reports it hasn’t made available to the agency, Deborah M. Autor, director of the FDA’s Office of Compliance, said today in a conference call with reporters. The agency told Matrixx in a letter today to stop selling three Zicam products.
“If they wish to continue marketing the products, the next step is for them to come in and seek FDA approval,” Autor said.
The products accounted for about 40 percent of Matrixx’s $111.6 million in sales for the fiscal year ended March 31, Matrixx said today in a statement. Matrixx said that while the products are safe, it is stopping all shipments and will issue refunds to customers.
“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its intranasal gel products and anosmia,” the company said in an e- mail. “For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company’s product safety data.”
Top Seller
The FDA warning applies to the Zicam Cold Remedy Nasal Gel, Gel Swabs and Kids Size swabs. Zicam, which also comes in melting tablet and liquid form, is Matrixx’s top-selling product.
The FDA first received reports of a loss of smell linked to Zicam in 1999. In 2006, Matrixx agreed to pay $12 million to settle claims by 340 plaintiffs who said they lost their sense of smell after using the product.
Today’s FDA letter says many homeopathic products can be sold without U.S. approval. Because of “a significant and growing body of evidence” that the Zicam products “may pose a serious risk to consumers,” the agency said Matrixx must get FDA approval to market its remedies.
To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net.
Last Updated: June 16, 2009 17:04 EDT |
