Zicam Won't Replace Recalled Nasal Cold Remedies.Sep 14, 2009 | Parker Waichman LLP
Don’t expect to see new versions of Zicam Nasal Cold Remedies in stores anytime soon. According to a report on StreetInsider.com, rumors that Matrixx Initiatives will be reformulating the recalled Zicam products are false.
Zinc gluconate, the active ingredient in Zicam products, has long been believed to produce a caustic action on the nasal passages that, over time, can lead to a loss of smell. Earlier this summer, the U.S. Food & Drug Administration (FDA) said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.
At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.
Since the Zicam recall, Matrixx Initiatives has been named in several class action lawsuits filed by people who blame the nasal remedies for their loss of smell. It also faces a class action lawsuit filed by investors that stems from the recall.
According to StreetInsider.com, the recalled Zicam products accounted for 40 percent of the company's sales. The recall has also hurt demand for other Zicam products, such as melting tablets and liquids, which were not subject to the FDA warning. So it would make sense that Matrixx would want to return the recalled Zicam products to the market as soon as possible, and reassure consumers about the safety of all remedies sold under the Zicam name.
Since the recall, rumors have swirled that Matrixx was considering reformulating nasal version of Zicam. According to StreetInsider.com, shares of Matrixx have jumped every time this rumor has surface.
But a company spokesperson told StreetInsider.com that Matrixx has absolutely no intention of reformulating recalled Zicam products. Instead, the company is hoping to reach an agreement with the FDA that would allow recalled versions of Zicam back on the market. According to the report, no such agreement has been reached so far.