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Advice for Patients: Denture CleansersIssued: February 14, 2008 FDA is asking the manufacturers of denture cleansers to revise labeling and to consider appropriate alternatives to an ingredient in their products. This action is in response to reports of 73 severe reactions linked to these cleansers, including at least one death. The ingredient, persulfate, which is known to cause allergic reactions, is the most likely cause of the problem according to literature and research. Persulfates are used in these products as part of the cleaning and bleaching process. Other reactions may be due to product misuse. The labeling revisions are needed to ensure that denture wearers clearly understand that these products are to clean dentures in a container-- not while still in the mouth. For example, some cleansers that contain mouthwash are described as minty fresh, or they may have graphics such as fizzing bubbles. This may mislead consumers by implying that the product may be chewed, gargled or swallowed. Who is at Risk?
What Are the Symptoms of Reaction? Allergic reactions can occur with both proper and improper use of these cleansers. Reactions may become more frequent and severe with repeated use of the product. Symptoms of an allergic reaction may include:
Symptoms from product misuse may include:
What Should Denture Wearers Do?
For more information see the Public Health Notification at http://www.fda.gov/cdrh/safety/022508-denturecleansers.html. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to FDA’s MedWatch Adverse Event Reporting program online, by mail or by FAX.
Updated February 25, 2008 |
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