Denture Cleanser Allergic Reactions and Misuse
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.
Nature of the Problem
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.
Recommendations
* Be aware that patients who wear dentures may present with symptoms of an allergic reaction, and that the denture cleanser may be the cause of the reaction.
* Educate your patients and their caregivers about the symptoms of an allergic reaction to persulfates in the denture cleanser. These symptoms can include irritation, tissue damage, gum tenderness, rash, urticaria, respiratory conditions and hypotension.
* Educate your patients and their caregivers about the proper use of denture cleansers. Even though the product labeling may mention mouthwash as an ingredient, the product should NEVER be ingested. Ingestion can result in esophageal ulcers, abdominal pain, vomiting, burns, irritation, breathing problems, hypotension, seizures, gum tenderness, bleaching of tissue, and blood in the urine.
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 Actions
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.
Reporting Adverse Events Related to Denture Cleansers
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.
Contacting FDA
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
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.
Nature of the Problem
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.
Recommendations
* Be aware that patients who wear dentures may present with symptoms of an allergic reaction, and that the denture cleanser may be the cause of the reaction.
* Educate your patients and their caregivers about the symptoms of an allergic reaction to persulfates in the denture cleanser. These symptoms can include irritation, tissue damage, gum tenderness, rash, urticaria, respiratory conditions and hypotension.
* Educate your patients and their caregivers about the proper use of denture cleansers. Even though the product labeling may mention mouthwash as an ingredient, the product should NEVER be ingested. Ingestion can result in esophageal ulcers, abdominal pain, vomiting, burns, irritation, breathing problems, hypotension, seizures, gum tenderness, bleaching of tissue, and blood in the urine.
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 Actions
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.
Reporting Adverse Events Related to Denture Cleansers
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.
Contacting FDA
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
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