Denture Cleaner Warning Issued by FDAFeb 26, 2008 | Parker Waichman LLP Denture cleaners like Polident and Fixodent have caused serious and sometimes fatal reactions in some users. US regulators announced Monday 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 Food and Drug Administration (FDA) blamed a bleach called persulfate, an allergen used in most denture cleansers, according to notices posted on the FDA’s Website. Persulfates are used in these products as part of the cleaning and bleaching process.
The FDA is urging doctors and patients to be aware of the symptoms of an allergic reaction and to only use the cleansers as directed. The one person who died and some of those who were sickened misused the cleaners, the FDA said. "Some patients have gargled or swallowed it, resulting in abdominal pain, vomiting, seizure, hypotension and difficulty breathing," it said. Meanwhile, some who reported allergic reactions used the cleaners properly, the FDA said. Allergic reactions happened quickly in some and after years of use in others, it said. The FDA didn't say how long it had been collecting reports of denture cleanser side effects, but recommended all denture cleanser makers add a warning about the risk of allergic reactions and place better patient instructions on package labeling.
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."
Other reactions may be due to product misuse. Denture wearers need to clearly understand the products are meant to clean dentures in a container, not in the mouth. Those at risk include people who are allergic to persulfates; users should understand an allergic reaction may not occur after the first use or even until many years of use; some symptoms may not appear for several minutes or hours after use. Those unable to read or understand the product label, such as people with poor eyesight or with a condition which compromises cognitive ability are also at risk.
Allergic reactions can occur with proper and improper use and reactions may become more frequent and severe with repeated use. Symptoms may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure. Product misuse can lead to esophagus damage, abdominal pain, burns, breathing problems, low blood pressure, seizures, tissue bleaching, blood in the urine, internal bleeding, and vomiting.
Denture Wearers are cautioned to read all package instructions carefully; never chew, swallow, or gargle with denture cleansers; always thoroughly rinse dentures and other dental appliances before placing them in the mouth; bear in mind that reactions might not occur immediately; remove dentures and contact the prescribing dentist if symptoms do occur; and ask the prescribing dentist about alternative cleaners.