Matrixx Says FDA Won't Budge on Recalled Zicam ProductsOct 28, 2009 | Parker Waichman LLP
It looks like federal health regulators aren't backing down when it comes to recalled Zicam Nasal Cold Remedies. According to a Reuters report, Matrixx Initiatives Inc., the maker of Zicam products, said the Food & Drug Administration (FDA) is "unwilling to reverse its position regarding the warning letter" it issued over Zicam nasal remedies earlier this year.
In June, the 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 The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.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.
According to Reuters, Matrixx said in a regulatory filing with the Securities and Exchange Commission (SEC) that the FDA will not reverse its stance that the recalled Zicam products could not be marketed without agency approval. The filing said the company is currently evaluating its options. Matrixx also said it was reviewing the FDA's contention that it should have filed adverse event reports on several individual Zicam loss of smell cases, and that it would be responding soon.
Since the Zicam nasal cold remedy recall, Matrixx has been hit with several class action lawsuits filed on behalf of people who claim the products caused them to suffer anosmia. Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam litigation for pretrial proceedings in the District of Arizona for coordinated handling.
According to Reuters, the recent SEC filing also disclosed that two shareholder derivative lawsuits were filed in September against current and former Matrixx officers related to the recall.