February 14, 2008
Dear Healthcare Provider:
This is to alert you to the risk of allergic reactions in users of denture cleansers, and the risks of misusing these products. The FDA has received at least 73 reports of adverse events, including at least one death, related to the use of denture cleansers. These adverse events have occurred both when the product has been used properly as well as from improper use. The allergic reactions can occur soon after the patient begins using the product, or after years of use.
The literature and research suggest that the ingredient in denture cleansers responsible for these reactions is persulfate, a known allergen. Persulfates are used in most denture cleansers to help clean and bleach the dentures.
In addition to reports of allergic reactions, FDA has also received reports of severe adverse events, including at least one death, resulting from misuse of the product. Some patients have gargled or swallowed it, resulting in abdominal pain, vomiting, seizures, hypotension and difficulty breathing.
Additionally, an accompanying Advice for Patients document can be found on the FDA website at http://www.fda.gov/cdrh/medicaldevicesafety/atp/022508-denturecleansers.html.
FDA is recommending that all manufacturers of denture cleansers modify their labeling to include warning information that the product contains persulfates, which are a known allergen, and to improve the directions for use on their labeling in order to reduce misuse. We are also recommending manufacturers consider appropriate alternatives to use of persulfates. We believe these actions will minimize the risk of adverse reactions.
We encourage you to report adverse events related to denture cleansers, whether caused by an allergic reaction or misuse. You can report cases directly to the device manufacturer or to MedWatch, FDA’s voluntary reporting program. This can be done on line at www.fda.gov/MedWatch/report.htm, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm. You can also report by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
If you have questions about this notification, please contact Nancy Pressly, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.
FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
Sincerely yours,
Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration
Updated February 25, 2008
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