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FDA Issues Warning for Over-the-Counter Cold Remedy
Date:6/16/2009

Zicam nasal products can cause loss of smell, officials stress

TUESDAY, June 16 (HealthDay News) -- U.S. health officials on Tuesday warned consumers to stop using Zicam nasal cold remedy products because they can cause the loss of a sense of smell.

The specific products contained in the warning include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs Kids' Size.

"These products claim to reduce the duration of the common cold and severity of cold symptoms," Deborah M. Autor, director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration, said during a morning teleconference Tuesday. "Consumers should stop using these products immediately."

The kids' products have been discontinued, but consumers may still have them in their households and are advised to discard or return them, officials said.

The products' manufacturer, Matrixx Initiatives, also received a warning letter and "must provide FDA with a plan on how it will remove existing inventory from the marketplace," Autor said.

"We have asked Matrixx in a warning letter to stop marketing the products, and we intend to work with them to address the products on the market and, at the same time, warn consumers to stop using and discard or return them," Autor continued. "We expect to hear a plan from the company."

According to Autor, the products have been marketed as homeopathic remedies and, therefore, have not needed FDA approval as long as the company complied with certain labeling and manufacturing requirements.

Now, the FDA is essentially asking Matrixx to take the unusual step of recalling the product, and then filing for new drug approval.

"The next step is for the company to come in and seek FDA approval if they want to continue marketing the products," Autor said.

"While the company has done trials involving small numbers of patients, we believe there have not been enough patients exposed in those trials to detect infrequent adverse events," she said.

According to Dr. Charles E. Lee, medical officer in the division of New Drugs and Labeling Compliance in CDER's Office of Compliance, the agency has received more than 130 reports from people using one of these zinc-containing products about the loss of a sense of smell, also known as anosmia.

"The loss of the sense of smell is potentially life-threatening and may be permanent," Lee said. "People without the sense may not be able to detect dangerous situations such as gas leaks, something burning in the house, or if food is spoiled before eating it. It also has a life-limiting effect, and can affect the livelihood of people in occupations where the sense of smell or taste is a crucial component."

Lee pointed out that, while the rate of adverse events seen here may not seem high, adverse events reports for over-the-counter drugs are historically low because consumers typically file their complaints with companies, not the FDA.

Until 2007, there was no requirement for makers of over-the-counter products to provide adverse event reports to the agency.

All reports of the latest problem have come from consumers and health-care providers, and Autor said the company has more than 800 adverse event reports related to the loss of sense of smell it has been asked to turn over to the FDA.

She declined to elaborate further on these reports, simply saying, "They have not been provided to the agency at this time."

Lee said the first reports of something amiss came in 1999, but seemed to speed up after 2004.

In 2006, Matrixx agreed to pay $12 million to settle several hundred lawsuits from consumers who claimed the zinc products had stripped them of their sense of smell. At the time, Matrixx said the settlements were not an admission of liability, the Washington Post reported.

According to Lee, both animal studies and historical medical literature indicate that zinc is actually toxic to the nerve receptors in the nose. Zinc was apparently used in the 1930s to try to prevent polio infection, he said.

More information

The National Library of Medicine has more on anosmia.



SOURCES: June 16, 2009, teleconference with: Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration; and Charles E. Lee, M.D., medical officer, Division of New Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, FDA; Jan. 30, 2006, Washington Post


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