The US Food and Drug Administration (FDA) has 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. The 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 healthcare professionals and
an ‘Advice for Patients’ document. The 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.
Tuesday, 15 October, 2024