Matrixx Initiatives may profess its surprise at the FDA's warning against its Zicam cold-care products, but the company admits it held onto 800 consumer complaints about side effects linked to the now-withdrawn nasal spray and swabs. The FDA didn't hear about those reports, in fact, until inspectors ran across them during a routine check in May, Matrixx President and COO William Hemelt told analysts.
Why didn't Matrixx alert FDA to the complaints? After all, aren't drugmakers obliged to report adverse events to FDA? Matrixx's lawyers told the company that a regulation requiring such reporting didn't apply to the Zicam complaints. "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."
Meanwhile, Matrixx plans to try to change FDA's mind. Maintaining that its products are safe, Hemelt said during the conference call that he hopes Matrixx has the opportunity to present data that he says prove the products don't cause a loss of smell. "We are certainly hoping for that outcome," he said, "but we are moving ahead as if that may not happen."