Consumers should immediately stop taking zinc-based intranasal Zicam cold products and discard them or return them to stores because they damage the sense of smell, the Food and Drug Administration said Tuesday.
The agency also ordered the products' manufacturer, Matrixx Initiatives of Scottsdale, Ariz., to stop marketing the products and said it would work with the company for their removal from stores.
In light of the health risks, if the company wants to market the products in the future, it would have to receive FDA approval just as it would for prescription drugs, said Deborah M. Autor, director of the office of compliance for the FDA's Center for Drug Evaluation and Research. The products, like other over-the-counter supplements, did not initially require such approval.
The loss of smell can be "life-threatening," Autor said, because people with impaired smell cannot detect leaking gas or smoke and cannot tell if food has spoiled before they eat it.
The products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size. The last product has been discontinued, but many consumers may still have it, Autor said.
The agency has received more than 130 reports of anosmia -- loss of the sense of smell -- associated with use of the products from doctors and consumers, she said. "The damage can be temporary or permanent," she said.
An additional 800 such reports are believed to have been made directly to the company. Companies have been legally required to forward such reports to the FDA since 2007, but Matrixx has not done so, Autor said. "We have asked Matrixx to provide to us the more than 800 reports they have. They have not been provided to the agency at this time," she said.
In an e-mailed statement, Matrixx said it would cooperate with the FDA, suspend shipments of the products and reimburse any consumer desiring a refund.
Matrixx has also been the subject of an unknown number of lawsuits related to the issue. Many have been settled out of court, but the company states on its website that "no plaintiff has ever won a court case because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell."
Dr. Charles E. Lee, a medical officer in the FDA's office of compliance, said that animal studies have shown that zinc damages nerve receptors in the nose, which can cause anosmia. He said reports of anosmia were also observed in the 1930s when zinc preparations were used in a failed attempt to prevent polio infections.
Matrixx, however, said, "The company believes the cumulative body of independent scientific and medical evidence supports both the safety and efficacy of Zicam intranasal cold products. . . . For this reason, Matrixx Initiatives believes that the FDA action is unwarranted and will seek a meeting with the FDA to review the company's product safety data."