Two more lawsuits have just been filed against the makers of recalled Zicam nasal cold remedy products, Matrixx Initiatives Inc. Both suits were filed in Hawaii, said KITV.com. In June, 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 over-the-counter cold 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 The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.
The FDA is not changing its position regarding recalled Zicam Nasal Cold Remedies. Reuters recently wrote that Matrixx said that the FDA is “unwilling to reverse its position regarding the warning letter” it issued over Zicam nasal remedies earlier this year.
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.
The FDA warned the firm that the products cannot be marketed without agency approval
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 the FDA, Zicam contains Zinc and Zinc could damage nasal nerves, reported KITV.com.
In a recent Reuters piece, it reported that 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.
KITV.com noted that hundreds of people nationwide have reported symptoms consistent with anosmia following use of Zicam products, such as the inability to smell and to taste food.
Marvin Yamasaki (59) of Hawaii Kai, alleges that he is unable to smell anything following use of Zicam two years earlier to help with a cold, said KITV.com. Yamasaki said that he lost his sense of smell within a few weeks, KITV.com added.
After seeking the assistance of an ear-nose and throat doctor
After seeking the assistance of an ear-nose and throat doctor, Yamasaki underwent surgery to resolve potentially blocked sinuses; the problem was not resolved and Yamasaki is still unable to smell and taste, said KITV.com.
Yamasaki said that certain aromas cause nausea and claustrophobia, “Celery has a very bad taste,” he said. “Strawberries have a weird, overly ripe, kind of bad, rotten,” quoted KITV.com.
In 2005, Matrixx agreed to pay $12 million to settle 340 lawsuits brought by consumers who claim the popular over-the-counter zinc nasal gel damaged or destroyed their sense of smell.
Although Matrixx was able to defended its product in 10 other lawsuits in the past five years, hundreds of people are now filing suit and expressing concern that the FDA was never advised that 800 people reported losing their sense of smell following use of Zicam, said KITV.com.
Matrixx has also faced a number of class action lawsuits and a recent SEC filing indicated that two shareholder derivative lawsuits were filed in September against current and former Matrixx officers related to the recall.