Zicam maker responds to FDA warning letter

SCOTTSDALE, Ariz. The Food and Drug Administration on Tuesday issued a surprise warning letter to Matrixx Initiatives around two of its 19 existing Zicam products, specifically Zicam Cold Remedy nasal gel and Zicam Cold Remedy swabs.

A third pediatric Zicam product was mentioned in the warning letter, though that product had been discontinued some years ago.

The warning letter cited some 130 consumer reports that the use of these products could cause a temporary or permanent loss of smell, known as anosmia. As a result, Matrixx is voluntarily recalling those products.

“We were surprised that the FDA decided to take this action without notifying us first, given our cooperative relationship with the FDA since we launched our first product in 1999,” commented William Hemelt, Matrixx acting president. “Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products.”

Hemelt said Matrixx currently is seeking an audience with the FDA “to vigorously defend its scientific data, developed during more than 10 years of experience with the products, demonstrating their safety.”

Since Zicam Cold Remedy intranasal cold remedy products were first introduced in the market in 1999, more than 35 million retail units, representing over 1 billion doses, have been sold, and the cumulative body of scientific and medical evidence compiled over those years has demonstrated both the safety and efficacy of Zicam intranasal cold remedy products under conditions of ordinary use, Matrixx stated in a press release.

All that suggests that less than 150 adverse event reports scuttled the experience of more than 35 million consumers.

“Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia,” Hemelt said. “It is well understood in the medical and scientific communities that the most common cause of anosmia is the common cold, which Zicam Cold Remedy intranasal gel products are taken to treat. Given the enormous number of doses sold and colds treated, there is no reason to believe the number of complaints of anosmia received is more than the number that would be expected in the general population. There is no reliable scientific evidence that Zicam causes anosmia.”

The alleged link between ansomia and Zicam use is not new. Matrixx has been contending with several lawsuits with consumers seeking damages suggesting that their Zicam use had caused ansomia. But many of those cases have been dismissed.

“We’ve had 10 federal judges exclude the expert witnesses for the plaintiffs, and consequently those cases have been dismissed,” Hemelt told analysts in May, with two of those dismissals having come in the previous quarter. “We also had some plaintiffs' lawyers say, ‘Look I'm not even going to bother to try to pursue the case,’ and they dropped their case.” Matrixx is still fighting approximately one dozen suits, but the number of those suits are diminishing, Hemelt said.