From Our 2009 Archives
FDA: Some Zicam Cold Remedies Are Risky
Agency Warns That Zicam Intranasal Products Containing Zinc May Lead to Loss of Sense of Smell; Company Calls FDA's Action 'Unwarranted'
Reviewed By Louise Chang, MD
June 16, 2009 -- The FDA today advised people not to use Zicam intranasal products that contain zinc, because of the risk of anosmia (loss of the sense of smell), which may be long-lasting or permanent.
The FDA's warning only applies to the following Zicam products:
"Consumers should stop using these products immediately and should discard or return them," Deborah Autor, director of the FDA's Office of Compliance, said at a news conference. Autor notes that Zicam Cold Remedy Swabs, Kids Size is no longer on the market, but consumers shouldn't use the product if they still have it at home.
Zicam's maker -- Matrixx Initiatives, Inc. -- has voluntarily withdrawn Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market, telling consumers to discard any of the affected products or request a refund by calling 877-942-2626 or visiting Zicam's web site.
All of the products covered in the FDA warning are sold over the counter, contain zinc, and are administered into the nose as a homeopathic treatment for colds. The FDA considers the products "misbranded," in part because the product labels don't warn about anosmia risk.
Autor noted that without the sense of smell, people "may not be able to detect dangers, such as gas leaks or something burning in the house, and may not be able to tell whether food is spoiled before eating," as well as having their quality of life diminished.
Zinc can damage receptors in the nose that are needed for smelling, notes Charles Lee, MD, a medical officer in the FDA's Office of Compliance.
The FDA has gotten more than 130 reports of anosmia in people using those products. Some of those people also reported a loss of their sense of taste, according to a warning letter the FDA today sent Matrixx Initiatives, Inc., the company that markets Zicam.
In that letter, which is posted on the FDA's web site, the FDA states that it "is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products." The FDA has asked Matrixx Initiatives to share those reports with the FDA.
The FDA has ordered Matrixx Initiatives to stop marketing the products without FDA approval, and to plan how to remove the products from the market, Autor said.
Matrixx Backs Zicam's Safety
In its news release, Matrixx states that "consumer safety is and has always been the company's top priority," and called the FDA's action "unwarranted."
Matrixx says it will seek a meeting with the FDA "to vigorously defend its scientific data, developed during more than 10 years of experience with the products, demonstrating their safety."
In the news release, William Hemelt, the acting president of Matrixx, says that the company "stands behind the science of its products" and that "there is no reliable scientific evidence that Zicam causes anosmia."
Hemelt said the FDA's action came as a surprise. "Had we had the opportunity to sit down with the FDA beforehand, we are confident that the FDA would have agreed that the scientific data clearly demonstrated the safety of our products."
SOURCES: Deborah Autor, director, Office of Compliance, Center for Drug Evaluation and Research, FDA. Charles Lee, MD, medical officer, division of new drugs and labeling compliance, Office of Compliance, Center for Drug Evaluation and Research, FDA. FDA: "Warning Letter." Statement, Matrixx Initiatives.
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