Denture cleansers – potential allergic reactions

The Australian Dental Association (ADA) has been alerted to the potential for denture cleansers to cause severe allergic reactions in certain cases.

The US Food and Drug Administration (FDA) have apparently 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, the Agency said.  The 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 immediately, but may do so after many years of use. Onset of symptoms of an allergic reaction may not appear for some time after actual use and may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure,” Dr John Matthews, federal president of the ADA, said today.

The Association advises that other reactions may be due to misuse of denture cleansers, and advises that consumers should never chew, swallow, or gargle with denture cleansers.

“To reduce misuse of denture cleansers, the FDA and ADA is recommending that manufacturers improve the directions on the label.

Labelling revisions are needed to make it clear that these products are meant to clean dentures in a container outside the mouth, not while still in the mouth.

“They advise that dentures should always be thoroughly rinsed with water before they are placed in the mouth.”

See:

www.fda.gov/cdrh/medicaldevicesafety/atp/022508-denturecleansers.html