Advice for Patients: Denture Cleansers

The Food and Drug Administration (FDA) has asked the manufacturers of denture cleansers to revise their labeling and consider appropriate alternatives to a particular ingredient in their products that can cause severe allergic reactions.

The Feb. 14, 2008, request came after the regulatory agency received 73 reports of severe reactions — including at least one fatality — to denture cleansers. The actual number of reactions may be 10 times higher than quoted by the agency, because most such reactions are not reported to the FDA.

According to the FDA, the most likely cause of these reactions is persulfate, a chemical known to cause allergic reactions. Persulfates are used in most denture cleansers to clean and bleach the dentures.

However, some reactions may be due to product misuse.

The FDA says these labeling revisions are needed to ensure that denture wearers clearly understand that these products are to clean dentures in a container — not while still in their mouths. This misuse may be facilitated by the products themselves. For example, some cleansers that contain mouthwash are described as “minty fresh.” This may mislead consumers by implying that the product may be chewed, gargled or swallowed.

Who is at risk?

People who are allergic to persulfates are at risk of a reaction. All users should be aware that this kind of allergic reaction may not occur after the first use or even until many years of use. Also, some symptoms may not appear for several minutes or even hours after actual use.

People with allergies to persulfates who are unable to read or understand the product label are at risk in particular. This could include people with poor eyesight or with a condition such as Alzheimer’s disease, which compromises cognitive ability.

What are the symptoms of reaction?

Allergic reactions can occur with both proper and improper use of these cleansers. Reactions may become more frequent and severe with repeated use of the product. Symptoms of an allergic reaction may include:

• Irritation
• Rash
• Hives
• Gum tenderness
• Breathing problems
• Low blood pressure

These cleansers can also cause a reaction in people who are not allergic to persulfate. When ingested, the chemical causes a local, non-allergic reaction with symptoms that can include:

• Damage to the esophagus
• Abdominal pain
• Burns
• Breathing problems
• Low blood pressure
• Seizures
• Bleaching of tissue
• Blood in the urine
• Internal bleeding
• Vomiting

What should denture wearers do?

• Read all instructions carefully
• Never chew, swallow or gargle with denture cleansers
• Always thoroughly rinse dentures and other dental appliances before placing in the mouth
• Remember that reactions might not occur right away
• If symptoms do occur, remove dentures and contact the prescribing dentist
• Ask the prescribing dentist about using an alternative method for cleaning dentures

Read the full Public Health Notification.