Company Defends Zicam Cold Remedies, Denies They Caused Loss of Sense of Smell

The makers of Zicam Cold Remedy products, recalled last month after dozens of reports of causing users to lose their sense of smell, are denying that the cold treatments caused the injuries.

Matrixx Initiatives of Scottsdale, Arizona said it disagrees with the Food and Drug Administration accusations that the company’s popular Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs caused at least 130 consumers since 1999 to report losing their senses of smell. The FDA also accused Matrixx of failing to disclose as many as 800 similar reports the company received from users.

The Zicam products were recalled nationwide last month, but Matrixx said it is planning to in essence appeal that decision to the FDA.

“Matrixx Initiatives vigorously disagrees with the FDA’s allegations that these products are not safe and that they were unlawfully marketed,” the company said, according to a report in the Southeast Texas Record. “The company is also in the process of preparing a submission to the FDA and, as previously reported, will soon ask to meet with the agency to present comprehensive scientific and medical data and analyses demonstrating that these products are safe.”

Because they are considered homeopathic drugs, the Zicam products were not subjected to the same rigorous FDA-approvals process before they were approved. The FDA has now ordered Matrixx to prepare a new-drug application for Zicam products to be submitted to the agency. Until then, the products remain off the market.

Texas Lawsuit Alleges Negligence

Mary Ann Brandon sued Matrixx on Jan. 7, 2009 in the Marshall Division of the Eastern District of Texas. After using a Zicam product to seek relief from a cold, Brandon said she felt an intense stinging and burning sensation in her nose and later lost all her sense of smell, according to the Record.

Brandon said subsequent medical treatment has only returned part of her sense of smell.

Her suit accuses Matrixx of negligence for marketing an unreasonably dangerous product, causing her injury. Hundreds of similar lawsuits are believed to have been filed across the United States.

In 2006, the company paid $12 million to settle claims from about 300 Zicam users who said they lost their senses of smell after using the cold remedies.

FDA Inspection Details Released

In other new Zicam news, today details of an FDA inspection of Matrixx’s facility in May 2009 were released. According to the FDA, “written procedures describing the handling of complaints are not followed” by the company. Matrixx has said it never told the FDA about the hundreds of complaints the company received directly from users claiming they lost their senses of smell because the company’s attorneys were of the opinion that the company was not legally obligated to do so.

Those consumer complaints show “some degree” of loss of smell in about 3.6 people for every 100,000 Zicam units sold, the FDA said. However, in 2004, consumer complaints of loss of sense of smell spiked and reached about 6.7 people per 100,000 units sold, the FDA said.

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