Suboxone Tooth Decay
OpenACTIVECausation
Suboxone sublingual film has a pH of approximately 3.4, well below the critical enamel demineralization threshold of 5.5. Prolonged mucosal contact during dissolution exposes teeth and gums to sustained acid attack. The FDA issued a Drug Safety Communication in January 2022 confirming 305 reports of serious dental adverse events including tooth decay, cavities, oral infections, and tooth loss. Plaintiffs allege Indivior knew the sublingual formulation caused dental damage but failed to include adequate warnings or recommend dental monitoring. The buprenorphine formulation's low pH combined with xerostomia (dry mouth) side effect accelerates enamel erosion.
Defendants
| Entity | Role | Note |
|---|---|---|
| Indivior Inc. | Manufacturer | Suboxone sublingual film — primary defendant and label holder |
| Indivior PLC | Parent Company | UK-based parent — spun off from Reckitt Benckiser in 2014 |
| Reckitt Benckiser | Former Manufacturer | Original manufacturer of Suboxone; potential legacy liability |
| Aquestive Therapeutics | Co-Developer | Developed sublingual film delivery technology under license |
Litigation Timeline
Intelligence Signals
The United States Trade Representative (Trade Representative) has determined that certain of Brazil's acts, policies, and practices at issue in this investigation are actionable under Section 301(b) and Section 304(a) of the Trade Act of 1974, as amended (Trade Act). The Trade Representative is proposing action, including tariffs on articles of Brazil and certain exemptions, and invites comments from the public.
Athwani P et al.. Journal of maxillofacial and oral surgery. 2026 Jun.
Status: TERMINATED. Phase: PHASE2. Conditions: Dental Pain. Sponsor: NanoSHIFT LLC. Interventions: NTC-510 capsules, Placebo Capsules, NTC-510A Capsules
Status: COMPLETED. Phase: N/A. Conditions: Buprenorphine, Naloxone, Opiate-related Disorders. Sponsor: Indivior Inc.. Interventions: buprenorphine
Status: COMPLETED. Phase: NA. Conditions: Dental Pain, Endodontically Treated Teeth. Sponsor: Hams Hamed Abdelrahman. Interventions: Mtwo R files with Xp-Endo finisher file, Mtwo R files
Status: COMPLETED. Phase: NA. Conditions: Opioid-use Disorder, Addiction, Depression. Sponsor: RAND. Interventions: Collaborative Care
Status: RECRUITING. Phase: PHASE4. Conditions: Opioid Use Disorder. Sponsor: VA Office of Research and Development. Interventions: Sublingual buprenorphine with naloxone, Injectable subcutaneous buprenorphine
The Drug Enforcement Administration (DEA) jointly with the Department of Health and Human Services (HHS) is issuing a fourth extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2026.
Notice published 2026-01-15
Purisys, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
The applications for exempt chemical preparations received by the Drug Enforcement Administration between September 1, 2024, and December 31, 2025, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through December 31, 2025, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.
Okeke CM et al.. Substance use : research and treatment. 2026 Jan-Dec.
Black AC et al.. PloS one. 2026.
Bye K et al.. Journal of the American Dental Association (1939). 2026 Feb 2.
Singh A et al.. Inflammopharmacology. 2026 Mar 2.
Roy PJ et al.. Journal of addiction medicine. 2026 Mar 12.
Key Facts
- Status
- active
Geographic Exposure
Eligibility Criteria
- ✓Prescribed Suboxone sublingual film for opioid use disorder
- ✓Developed severe tooth decay, tooth loss, or oral tissue damage during or after use
- ✓Used Suboxone film for 6+ months before onset of dental problems
- ✓Had no pre-existing severe dental condition prior to Suboxone use
- ✓Required dental procedures (extractions, root canals, crowns) as a result