Denture Cleaners Blamed for Serious - and Sometimes Fatal - Allergic ReactionsMar 11, 2008 | Parker Waichman LLP
Denture cleaners could be toxic to some users. Last month, the US Food and Drug Administration (FDA) announced that one person died and at least 72 others were sickened as a result of allergic reactions to denture cleaners. In some cases, the reactions were a result of product misuse. The FDA is blaming a bleach called persulfate, an allergen that is used in most denture cleansers as part of the cleaning and bleaching process.
According to the FDA, the reactions have occurred with both proper and improper use of the denture cleaning products. While some patients have had problems because of product misuse, it is important to understand that some of those people who reported allergic reactions actually used the cleaners properly, according to the FDA. Of issue with persulfates is that allergic reactions do not always occur after the first use or even until after many years of use. Also, symptoms of an allergic reaction may not appear for several minutes or even hours after actual use and may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure.
Other reactions may be caused by misuse of denture cleansers. For example, while some of the cleansers may list mouthwash as an ingredient, consumers should never chew, swallow, or gargle with denture cleansers. Some patients who have gargled or swallowed denture cleansers, have experienced abdominal pain, vomiting, seizures, breathing problems, and low blood pressure. Product misuse can also lead to esophagus damage, burns and tissue bleaching, blood in the urine, and internal bleeding. Allergic reactions happened quickly in some and after years of use in others, the FDA said; the FDA didn't say how long it had been collecting reports of denture cleanser side effects. Allergic reactions can become more frequent and even more severe with repeated use, but again, reactions can appear suddenly as well as after time or can build up gradually.
And, now, 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. The FDA is hoping that improved label directions will help reduce the misuse of the cleansers. Also, label revisions must be made so that instructions are very clear on the fact that denture cleansers are meant to clean dentures in a container and never in the mouth. Dentures should always be thoroughly rinsed with water before they are placed in the mouth. The FDA is also recommending that manufacturers consider appropriate alternatives to persulfates.
GlaxoSmithKline, maker of Polident and Procter & Gamble Co., maker of Fixodent, said their products were safe when used as directed. "The amount of persulfate contained in Polident is lower than the level that is known to cause an allergic reaction," said Jennifer May, a spokeswoman for London-based Glaxo. "Millions of consumers have used Polident" and have reported "a very low number of product complaints or adverse reactions." Laura Brinker, a spokeswoman for Cincinnati-based Procter & Gamble, said Fixodent's packaging "contains simple, three-step instructions about proper use of the product."