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By Janie Fuller, DDS, MPH
Director, Regulatory Review Office
Center for Devices and Radiological Health
Food and Drug Administration Rockville, Md
Case 1: An 81-year-old man soaked his dentures in an over-the-counter (OTC) denture cleanser then gargled with the remaining solution. His tongue became swollen and blue. Despite emergency efforts that included CPR and administration of isosorbide dinitrate, he died at the scene.
Case 2: An 84-year-old woman with a history of Alzheimer's dementia, confusion, and paranoia ate one tablet of an OTC denture cleanser. Afterward, she vomited a green substance, became delirious, and required treatment in the ED to survive.
Case 3: A 74-year-old nursing home resident with bronchitis ate approximately six denture cleanser tablets. She was found foaming at the mouth and having difficulty breathing. Her esophagus was irritated and her chest distended. After suffering cardiopulmonary arrest, she received CPR, was admitted to the hospital, and survived.
What went wrong?
Denture cleansers aren't intended for internal use, but in all three cases, they were gargled or swallowed. Some OTC denture cleansers contain ingredients associated with allergic reactions, including anaphylaxis; other ingredients can imtate mucosa and may be toxic if ingested.
What precautions can you take?
Carefully monitor your patients' use of denture cleansers, especially patients who may have difficulty reading or understanding label warnings and cautions. Teach patients who wear dentures to carefully read all denture cleanser labels and heed all warnings and cautions. Warn them never to chew, swallow, or gargle with denture cleansers. Remind them to always thoroughly rinse dentures and other dental appliances before placing them into the mouth.
LeCoz, C., and Bernard, M.: "Allergic Contact Cheilitis Due to Effervescent Dental Cleanser: Combined Responsibilities of the Allergen Persulfate and Prosthesis Porosity," Contact Dermatitis. 41(5):268-271, November 1999.
Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn't perform as intended by calling MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178). The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Device Safety is coordinated by Beverly Albrecht Gallauresi, RN, MPH, BS.