One person died and at least 72 others were sickened by allergic reactions to denture cleaners, sometimes because of misuse of the products, U.S. regulators said Monday.
The Food and Drug Administration blamed a bleach called persulfate, an allergen used in most denture cleansers, according to notices posted on the agency's website. The agency urged doctors and patients to be aware of the symptoms of an allergic reaction and to use the cleansers as directed.
The person who died and some 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.
Some people who reported allergic reactions used the cleaners properly, the FDA said. Allergic reactions happened quickly in some people and after years of use in others, it said. The agency didn't say how long it had been collecting reports of side effects.
The FDA recommended that all makers of denture cleansers add a warning about the risk of allergic reactions and put 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."