Suboxone Tooth Decay: FDA Warning and Lawsuit Records

What the FDA warning says

On January 12, 2022, the FDA warned about reports of serious dental problems with buprenorphine medicines dissolved in the mouth, including cavities, infections, and tooth loss. Reports included people without previous dental problems. The agency required new warning information and said the medicines' benefits outweigh the risks. Source: FDA drug safety communication.

The communication covers certain tablets and films dissolved in the mouth. It distinguishes these from other delivery routes, such as patches and injections, for which it had not identified the same dental concern at the time of the communication. A prescription name alone is therefore insufficient to identify the formulation involved. Source: FDA explanation of affected formulations.

Medication decisions belong with the prescribing clinician. The FDA advises patients not to stop buprenorphine suddenly without discussing treatment with a health professional. Bring dental concerns to the prescriber and dentist. Source: FDA patient guidance.

What the Suboxone film litigation alleges

The Northern District of Ohio describes MDL 3092 as litigation over alleged dental erosion and decay associated with Suboxone film. The claims raise questions about formulation, testing, causation, and warnings. These are allegations that defendants dispute. The FDA communication is not a court finding that a particular person's dental condition was caused by the medicine. Source: official MDL 3092 court description.

The national Suboxone guide tracks the broader case. This page focuses on the formulation and records questions that can otherwise get lost in settlement or case-count headlines.

Records that connect use and dental history

Print the Suboxone records worksheet to organize providers, prescription dates, dental treatment, expenses and missing records before a conversation with an attorney. You can print it or save a blank PDF; it does not collect or submit health information.

The court's March 31, 2026 amended records order addresses proof of Suboxone film use, dental records, and other treatment records. Its attached authorization includes prescription information, clinical records, bills, and dental imaging. Source: amended CMO 13 and Exhibit A.

• Medicine: organize pharmacy histories by date, with the product name, manufacturer where available, strength, and film or tablet form.
• Dental history: list dentists and clinics seen before, during, and after use, including dates of examinations, X-rays, diagnoses, and procedures.
• Treatment and costs: keep treatment plans, procedure records, invoices, and insurance statements together.
• Timeline: distinguish the date symptoms were noticed from the date a dentist recorded a diagnosis. Mark uncertain dates and missing records.

This is a suggested organization method, not a substitute for the court's authorization forms or an assessment of causation. A lawyer can identify the records required for a particular case.

A dental problem is a starting point for review

A record file should accurately describe both earlier dental care and later problems. Avoid changing or discarding records because they seem inconsistent with a claim. Separate what the records say from what remains a question for a clinician or lawyer.

The MDL 3092 guide links to the court's orders. State filing issues and orders in an existing case require separate attention; the FDA warning date should not be treated as an automatic filing deadline.