Healthy Skepticism Library item: 15842

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Publication type: news

Pettypiece S.
Matrixx Said It Didn’t Give 800 Zicam Reports to FDA (Update1)
Bloomberg.com 2009 Jun 18
http://www.bloomberg.com/apps/news?pid=20601202&sid=aDC21YXDGWvY

Full text:

Matrixx Initiatives Inc. said today it didn’t turn over to U.S. regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.

Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning “a surprise,” during a conference call with analysts.

The FDA found 800 reports of consumer concerns in May during a routine inspection, William Hemelt, acting president and chief operating officer of Matrixx, said today during the call. Hemelt said he was told by lawyers that a 2007 regulation requiring companies to turn over reports of serious side effects didn’t apply to the complaints received by Matrixx. The recall will cost the company $10 million and will increase its product liability costs, he said.

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA said June 16 that it had received 130 reports from doctors and consumers about permanent loss of smell linked to the medicines. FDA spokeswoman Siobhan DeLancey said in a June 16 telephone interview that Matrixx was required to turn over reports of side effects to the FDA according to the 2007 regulation.

The company today withdrew its earnings and sales forecast for 2010.

Matrixx fell 12 cents, or 1.9 percent, to $6:01 at 4 p.m. in New York Stock Exchange composite trading. It has lost 63 percent of its value in the past 12 months.