Suboxone — a brand-name combination of buprenorphine and naloxone — has been widely prescribed as a medication-assisted treatment for opioid use disorder. For many patients, it has been a critical part of recovery. However, in recent years, a growing body of evidence has linked Suboxone and similar buprenorphine-containing sublingual films to serious and sometimes severe dental injuries, including tooth decay, fractures, and tooth loss.
What Has the FDA Said About Suboxone and Dental Risks?
In January 2022, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the use of buprenorphine medicines dissolved in the mouth — including Suboxone sublingual film — can cause dental problems. The FDA noted that cases of serious dental harm had been reported even in patients with no prior history of dental disease. The FDA subsequently required manufacturers to add a new warning to the labeling for these products.
The FDA warning was significant because it suggested that patients had not been adequately informed of this risk prior to taking the medication. Critics of the manufacturer, Indivior, have argued that the company knew or should have known about the dental risks earlier and failed to act appropriately.
What Legal Claims Are Being Filed?
Plaintiffs in the Suboxone litigation allege that Indivior failed to adequately warn healthcare providers and patients about the risk of dental injuries associated with long-term use of the sublingual film formulation. Cases have been filed in both federal and state courts, and litigation has been advancing through key pretrial stages.
In January 2025, a court advanced key claims in the Suboxone dental injury litigation, signaling that the case is moving forward. Kershaw Talley Barlow has been tracking this litigation closely and represents clients who have experienced dental injuries in connection with Suboxone use.
Who May Have a Claim?
You may wish to speak with an attorney if you used Suboxone sublingual film or another buprenorphine sublingual product and experienced significant dental problems during or after use, including tooth decay, dental abscesses, cracked or broken teeth, or tooth loss. These cases are evaluated individually, and eligibility depends on the specific facts of each person's situation.
If you or someone you know has been affected by dental injuries potentially linked to Suboxone use, we encourage you to consult with an attorney to understand your rights. Kershaw Talley Barlow offers free consultations and represents clients nationwide.
Learn more about the Suboxone litigation: https://www.ktblegal.com/mass-torts/suboxone/
