Bloomberg News reports, “Matrixx Initiatives Inc. said today it didn’t turn over to US regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.” The company halted sales of “the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell.” The agency “found 800 reports of consumer concerns in May during a routine inspection,” according to William Hemelt, acting president and chief operating officer of Matrixx. He added that “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.”
Dow Jones Newswires reports that the company “is defending its Zicam cold and allergy products,” seeking “to meet with the agency to discuss the scientific data concerning the products and the safety concerns the FDA raised.” Hemelt said, “We are hopeful that if we can tell our story to the FDA, that maybe we can get them to change their mind.” He commented that “the safety concerns are ‘erroneous’ and said that the agency made no effort to communicate its concerns with the company prior to this week.”
From the American Association for Justice news release.
