Denture Cleanser Linked to Serious Allergic Reaction and Death

February 26, 2008—The US Food and Drug Administration (FDA) is warning consumers about the risk of severe allergic reaction and death associated with the use of denture cleansing products. The FDA has received at least 73 reports of adverse events, including one death related to both proper and improper use of denture cleansers. Persulfates, the chemical bleaching agents used in most denture cleansers are thought to be responsible for these reactions.

Symptoms of Allergic Reaction to Persulfates

Allergic reaction to denture cleansers may occur after the first use or after many years of usage. Symptoms of an allergic reaction can take several minutes or hours to appear.

· Irritation

· Tissue Damage

· Rash

· Hives

· Gum Tenderness

· Breathing Problems

· Low Blood Pressure

FDA Recommends Modification to Warning Label

The FDA has recommended that manufactures modify product labels to include a warning that the product contains persulfates, a known allergen, and to improve directions for use in order to reduce incidences of misuse. According to the FDA, denture cleansers that contain mouthwash are often described as “minty fresh” or utilize fizzing bubble graphics, which imply that the product can be chewed, gargled or swallowed. Symptoms associated with ingestion of denture cleansers may include:

· Damage to the esophagus

· Abdominal pain

· Burns

· Breathing problems

· Low blood pressure

· Seizures

· Bleaching of tissue

· Blood in the urine

· Internal bleeding

· Vomiting