FDA Alert on Denture Cleansers

FDA notified dental healthcare professionals and patients of the risk of serious allergic reactions in users of denture cleansers.
These adverse events, including abdominal pain, vomiting, seizures, hypotension and difficulty breathing, have occurred both
when the product has been used properly as well as from improper use. These events can occur soon after first use or after years
of use. FDA believes that the ingredient responsible for these reactions is persulfate, a known allergen. Persulfates are used in
most denture cleansers to help clean and bleach the dentures. FDA has provided specific recommendations for dental health care
professionals and an 'Advice for Patients' document.

FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the
product contains persulfates and recommends improving the directions for use on their labeling in order to reduce misuse.


See the MedWatch 2008 safety summary, including links to the Public Health Notification and "Advice for Patients", at:
Click here
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