Case guide
The FDA dental warning covers drugs that dissolve in the mouth. Ask your dentist and prescriber about care, and do not stop treatment on your own.
Updated Oct 4, 202610 sources
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Updated Oct 4, 202610 sources
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Mahyar Etminan · Faculty of Medicine, University of British Columbia · Lead author of the dental claims-database study
Finding: The study recorded more dental problems among users of medicine held under the tongue than in its comparison groups.
Etminan and colleagues: dental disease cohort, JAMA 2022 (opens in a new tab) · Dec 13, 2022 · Checked Oct 3, 2026
University of British Columbia · JAMA · 2022
Read the source: Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease (opens in a new tab) · Checked Oct 3, 2026
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The warning covers films and tablets that dissolve in the mouth. That includes Suboxone and generic drugs.
FDA had not identified the same dental concern for skin patches or injections in this alert. That is the scope of this warning, not a promise that another treatment has no risks. Do not change the form you take without advice from the person prescribing it.
Reports describe decay, mouth infection and lost teeth. Some people had no past dental problems.
The alert counted reports and cases in medical literature, not a survey of every patient taking the drug. FDA says it cannot tell how likely these effects are for one person. Report your own changes to the dentist instead of using the report count as a personal risk rate.
Do not suddenly stop it on your own. FDA says the treatment benefits outweigh the risks and advises speaking with your provider.
Discuss dental concerns with both the prescriber and dentist. The warning calls for a dental check and a plan to prevent decay. A legal inquiry can happen alongside care; it is not a reason to end treatment or choose a different medicine yourself.
Gently rinse your teeth and gums with water after the medicine fully dissolves, then swallow. Wait at least one hour before brushing.
These are FDA’s patient steps for the mouth-dissolved medicines. Ask your provider to explain them if your instructions are unclear. Keep the leaflet and tell your dentist what you take so the dental care plan accounts for the medicine and your oral health history.
A 2022 claims study found more dental diagnoses among under-tongue users. It cannot say what caused one person’s tooth damage.
The researchers compared treatment groups rather than assigning drugs in a trial. Oral hygiene information was missing, and the records captured dental events reported to a physician. Keep those limits in view when discussing the warning or any claim with a professional.
Keep the prescription, warning leaflet and dental visit records. Ask a lawyer to check the facts and deadline for any claim.
Covered providers generally allow access to medical and billing records, subject to exceptions and copying fees. A court complaint and a request for advice are different steps. Ask the firm about acceptance, filing and written fee terms; the alert date is not a universal filing deadline.
The review is free and private. Asking for it doesn’t commit you to anything.
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