On Tuesday, the Food and Drug Administration (FDA) warned consumers to stop using certain products from Zicam, as use of these products have been linked to anosmia, or loss of the sense of smell.
The products involved are:
- Zicam Cold Remedy Nasal Gel
- Zicam Cold Remedy Nasal Swabs
- Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
The FDA's press release about the Zicam alert said:
The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”
People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.
Zicam manufacturer Matrixx Initiatives Inc. saw its stock plummet 55.5% to $8.56 before trading was halted. Zicam has responded via a website, zicamlawsuits.com, where they said:
Matrixx Initiatives, Inc., the manufacturer of Zicam Cold Remedy intranasal zinc gluconate gel products, affirms that its intranasal gel products do not cause hyposmia (diminished sense of smell) or anosmia (loss of smell), and allegations to the contrary are scientifically unfounded and misleading. The company’s position is supported by the cumulative science and has been confirmed by a multi-disciplinary panel of scientists and the decisions of 10 separate federal judges evaluating scientific evidence in 10 different cases.
Although plaintiffs and their attorneys hoping for financial gain have sued Matrixx, 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. No well-controlled scientific study has demonstrated a potential cause-and-effect relationship between use of Zicam and diminished smell function. No court cases have revealed any reliable evidence of any causal relationship. All scientific research and all controlled scientific studies to date have shown that Zicam is not a likely cause of smell dysfunction, and all of the anecdotal speculation offered in court has been discredited as unrelated, unreliable or deeply flawed.
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