Another consumer is saying that a <"http://www.yourlawyer.com/topics/overview/Zicam">Zicam nasal cold remedy caused him to lose his sense of smell as well as 60 pounds, reports the New York Post. The man, from Long Island, New York, said that food â€œhas lost its taste,â€ quoted the Post, citing a federal lawsuit.
Frank Catalano, 57, of Huntington, New York, said he bought the Zicam Cold Remedy nasal gel swabs last January and has not only fully lost his sense of smell, but now longer enjoys food, said the Post.
In June, the U.S. Food & Drug Administration (FDA) said it had received 130 reports of anosmiaâ€”loss of sense of smellâ€”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 The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.
Most recently we wrote that two more lawsuits were filed against the makers of recalled Zicam nasal cold remedy products. Both suits were filed in Hawaii.
Also, the FDA is not changing its position regarding recalled Zicam Nasal Cold Remedies. Reuters recently wrote that Matrixx said that the FDA is â€œunwilling to reverse its position regarding the warning letterâ€ 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 admitted it did not pass along those reports to the FDA and maintains 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 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 FDAâ€™s contention that it should have filed adverse event reports on several individual Zicam loss of smell cases
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 defend 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 many hundreds of people reported losing their sense of smell following use of Zicam, said KITV.com, previously. 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.