Pediatrics Community
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
About This Community:

This patient support community is for discussions relating to allergies, behavior, developmental disorders, immunizations and vaccines, puberty, and any other pediatric health issues including brain, bone, heart, lungs, gastrointestinal and urological in adolescents, infants, newborns, and toddlers.

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

"FDA NEWS RELEASE

For Immediate Release: June 16, 2009

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey @ fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Intranasal Zinc Product Linked to Loss of Sense of Smell

The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

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.

“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.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

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 [https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm]
    --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"
Related Discussions
Post a Comment
To
Blank
Weight Tracker
Weight Tracker
Start Tracking Now
Pediatrics Community Resources
RSS Expert Activity
469720_tn?1388149949
Blank
Abdominal Aortic Aneurysm-treatable... Blank
Oct 04 by Lee Kirksey, MDBlank
242532_tn?1269553979
Blank
The 3 Essentials to Ending Emotiona...
Sep 18 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Control Emotional Eating with this ...
Sep 04 by Roger Gould, M.D.Blank
Top Children's Health Answerers
4851940_tn?1385441629
Blank
jemma116
United Kingdom