Safety Problems with Denture Cleansers





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Published on Jul 8, 2009

FDA wants healthcare professionals to know about two serious safety problems that have occurred in patients who use denture cleansers. The first is the risk of allergic reactions to these products. These reactions can arise soon after the initial use, or after years of exposure. Symptoms include gum tenderness, rash, urticaria, respiratory distress and hypotension.

Research suggests that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers as cleaning and bleaching agents.

The second safety problem is mis-use. Some of these products have mentioned mouthwash as an ingredient, and some have been described as "minty fresh." If patients are confused by this, they may mistakenly rinse their mouths with the product, gargle with it, or swallow it. That can cause bleaching of tissue, gum damage, vomiting, seizures and hypotension.

Healthcare professionals should be aware that patients with dentures may present with symptoms of an allergic reaction, and that a denture cleanser may be the cause.

FDA has asked manufacturers of denture cleansers to warn in the labeling about allergic reactions, and to consider using alternative ingredients in place of persulfates.

FDA Patient Safety News: July 2009

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