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Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)

From: FDA MedWatch [mailto:fda@service.govdelivery.com]
Sent: Tuesday, June 16, 2009 12:21 PM
To: Trachtenberg, Alan (IHS/HQE)
Subject: MedWatch - Zicam Cold Remedy Nasal Products: Reports of permanent loss of sense of smell with use of these nasal gel or swab products

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)

Audience: Consumers

FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the 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.

Read the complete MedWatch 2009 Safety Summary, including links to the Public Health Advisory and Consumer Update page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

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