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Consumer Update |
FDA has received at least 73 reports of adverse reactions, including at least one death, related to the use of denture cleansers. Problems have occurred with both proper and improper use of these products.
FDA is asking manufacturers of denture cleansers to include a warning in the label about persulfates, which are known to cause allergic reactions in some people. Persulfates are used in most denture cleansers as part of the cleaning and bleaching process. The agency is also recommending that manufacturers consider appropriate alternatives to persulfates.
An allergic reaction to persulfates may not occur after the first use or even until after many years of use. Symptoms of an allergic reaction may not appear for several minutes or even hours after actual use. Symptoms may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure.
Other reactions may be due to misuse of denture cleansers. For example, some cleansers may list mouthwash as an ingredient, but consumers should never chew, swallow, or gargle with denture cleansers.
To reduce misuse of denture cleansers, FDA is also recommending that manufacturers improve the directions on the label. Labeling revisions are needed to make it clear that these products are meant to clean dentures in a container, not while still in the mouth. Some patients have gargled or swallowed denture cleansers, resulting in abdominal pain, vomiting, seizures, breathing problems, and low blood pressure. Dentures should be thoroughly rinsed with water before they are placed in the mouth.
Advice for Patients: Denture Cleansers
http://www.fda.gov/cdrh/medicaldevicesafety/atp/022508-denturecleansers.html
FDA Public Health Notification: Denture Cleanser Allergic Reactions and Misuse
http://www.fda.gov/cdrh/safety/022508-denturecleansers.html
Date Posted: March 7, 2008
