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FDA warns Zicam products linked to loss of smell

June
16

A popular cold remedy could cause permanent loss of smell, the U.S. Food and Drug Administration is warning. The FDA is advising consumers to stop using three Zicam products marketed over-the-counter as cold remedies because they can cause  long-lasting or permanent loss of smell.

The products are:

• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Nasal Swabs
• Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

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.

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.

Health care professionals and consumers are encouraged to report adverse events (side effects) that may be related to the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.—Online—Regular Mail: use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787—Fax: 800-FDA-0178—Phone: 800-FDA-1088

For more information:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm166834.htm

This entry was posted on Tuesday, June 16th, 2009 at 2:34 pm by Jane Lerner. Print This Post Print This Post | Email This Post Email This Post

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One Response to “FDA warns Zicam products linked to loss of smell”

  1. ed1

    This could be good news for those living around the Albany area.

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