NEW YORK (Reuters) March 3 The Food and Drug Administration (FDA) has notified dental healthcare professionals and the public of the risk of serious allergic reactions for users of denture cleansers.
According to information posted on the "MedWatch" section of the FDA's Web site, the action is in response to reports of 73 severe reactions linked to denture cleansers, including at least one death.
These adverse events include abdominal pain, vomiting, seizures, low blood pressure, and difficulty breathing and have been reported both with proper and improper use of denture cleansers. "These events can occur soon after first use or after years of use," the notification reads.
Other less severe allergic reactions to denture cleansers may include irritation, tissue damage, hives, rash, and gum tenderness.
The FDA says the ingredient in denture cleansers most likely responsible for these reactions is persulfate, which is known to cause allergic reactions. Persulfates are used in most denture cleansers to help clean and bleach the dentures, the agency notes.
The FDA has recommended that makers of denture cleansers clearly state on package labels that the product contains persulfates, which may cause an allergic reaction.
They also want package labels revised to ensure that denture wearers clearly understand that these products are to clean dentures in a container -- not while still in the mouth.
"For example, some cleansers that contain mouthwash are described as minty fresh, or they may have graphics such as fizzing bubbles. This may mislead consumers by implying that the product may be chewed, gargled or swallowed," FDA explains in an 'Advice for Patients' document.
The agency advises that denture cleansers should never be swallowed or used for gargling, and dentures should always be rinsed thoroughly after cleaning.
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