Posted by: Salvatore J. Zambri, Esquire
Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.
According to the report, "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 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May. William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn’t apply.
“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 reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.
When companies withhold critically important information it smacks of putting profits over people. Safety and public health should always be the paramount concern of drug companies.
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