The FDA Suboxone Dental Warning — January 2022

What the FDA Found

The FDA reviewed 305 case reports of dental adverse events associated with buprenorphine medicines dissolved in the mouth, submitted to the FDA Adverse Event Reporting System (FAERS) between the time these medicines were approved and October 2021. The FDA found that the dental problems reported were severe. The most common adverse events reported were tooth decay, cavities, oral infections, and tooth fractures. Some of the reported cases resulted in tooth loss. In 26 cases, patients required complete tooth removal. Treatment reported to address these issues included root canals, tooth extractions, dental implants, and dentures.

The FDA noted that the dental problems occurred in patients with no prior history of dental disease, as well as in patients who reported good dental hygiene. The agency found that the dental adverse events occurred with all dosages, formulations, and durations of buprenorphine sublingual treatment. These findings confirmed that the dental injury risk is a product characteristic — not a result of patient behavior — strengthening the legal argument that Indivior's failure to warn was causally connected to the injuries sustained.

What the FDA Required Manufacturers to Do

As a result of its safety review, the FDA required manufacturers of buprenorphine medicines dissolved in the mouth to add new warnings to their prescribing information and patient medication guides. The new labeling warns about the risk of serious dental problems and advises patients to: rinse their mouth gently with water after the medicine has fully dissolved, gently rub the water around their teeth and gums, and wait at least one hour before brushing teeth. The FDA also advised patients to tell their dentist that they are using buprenorphine and to seek routine dental care during treatment. The fact that these simple, effective mitigation steps exist — and were never communicated to patients before January 2022 — underscores the preventable nature of the dental injuries and the significance of Indivior's failure to warn.

Legal Significance: The Discovery Rule and the January 12, 2022 Date

In product liability law, the statute of limitations clock starts when the plaintiff knew or should have known that a product caused their injury — not necessarily when the injury occurred. Before January 12, 2022, most patients who had sustained dental injuries while taking Suboxone had no official basis to connect their medication to their tooth damage. The FDA's safety communication provides a documentable, objective date on which the Suboxone-dental injury connection was established by the federal government. Plaintiff attorneys across the country are arguing that this date resets or triggers the statute of limitations for affected patients — meaning that patients in 2-year SOL states had until January 12, 2024, and patients in 3-year SOL states had until January 12, 2025, to file claims. Courts have not uniformly adopted this interpretation, and individual circumstances (such as a dentist noting a possible Suboxone connection before 2022) can affect the analysis. Consultation with an attorney is essential.