Suboxone® Sublingual Film, has been used to treat opioid use disorder (OUD) and chronic pain for many years. Administered under the tongue (sublingually) or inside the cheek (buccally) it helps alleviate withdrawal symptoms and reduce opioid cravings. Suboxone is a combination of buprenorphine and naloxone. It is an opioid itself and produces the same effects but at a very low dose. However, recent concerns have emerged regarding its potential link to severe dental problems, leading to lawsuits against its manufacturer, Indivior.
FDA Warning and Dental Health Concerns
In January 2022, the U.S. Food and Drug Administration (FDA) issued a warning about dental problems associated with buprenorphine-containing medications that are dissolved in the mouth. Reported problems include tooth decay, cavities, oral infections, and even tooth loss, sometimes occurring in patients with no prior history of dental problems. The FDA emphasized that while buprenorphine remains a vital treatment for OUD and pain management, patients should be informed of these potential risks and the actions they can take to reduce those risks.
How Suboxone Causes Problems
Users of Suboxone Sublingual Film must hold it under their tongue or in the cheek for several minutes until it is completely dissolved. The drug is very acidic and exposes the teeth and gums to its acidic properties. People were not always instructed to rinse their mouths with water to flush out the remaining acids and to delay brushing their teeth after use. Prolonged and repeated exposure increases the risk of tooth decay because acids erode the enamel on teeth. This makes the teeth more vulnerable, to bacteria that can cause cavities, infections, and fractures of the teeth. Ultimately, tooth loss can occur.
Suboxone can also cause dry mouth, which can cause dental problems, including tooth decay, over time. Opioids are also known to increase sugar cravings in many people. Sugar is a well-known contributor to tooth decay.
Legal Actions and Allegation
Following the FDA’s warning, numerous patients who experienced dental issues after using Suboxone initiated legal actions against Indivior. The primary allegations in these lawsuits are:
- Failure to Warn: Plaintiffs claim that Indivior was aware of the potential dental risks associated with Suboxone but did not provide adequate warnings and instructions to patients or healthcare providers.
- Negligent Design: The lawsuits argue that the sublingual film form of Suboxone has a highly acidic pH, which can erode tooth enamel, leading to decay and other dental problems.
- Insufficient Testing: Indivior allegedly did not conduct comprehensive testing regarding the long-term effects of Suboxone on dental health before bringing the product to market.
Multidistrict Litigation (MDL) Development
Due to the increasing number of lawsuits, a multidistrict litigation was established in the Northern District of Ohio under Judge Philip Calabrese. Multidistrict litigation (MDL) is a legal process that groups related federal civil cases into one federal court for pretrial proceedings. The goal is to avoid duplicative discovery, inconsistent rulings, and conserve resources. As of February 1, 2025, the MDL had consolidated 754 pending cases.
There are several dental issues that have been associated to Suboxone by people who have not had previous dental problems. These include:
- Abscesses
- Cavities
- Losing fillings
- Teeth loss
- Oral infections
- Tooth decay
- Tooth fractures
Eligibility Criteria for Potential Plaintiffs
Individuals who have suffered dental issues after using Suboxone may wonder about their eligibility to join the ongoing litigation. General criteria include:
- Prescription History: Having been prescribed Suboxone, particularly the sublingual film or tablet forms that must be dissolved in the mouth.
- Dental Health Impact: Experiencing significant dental problems, such as tooth decay, erosion, or tooth loss, that began after starting Suboxone treatment.
- Lack of Prior Dental Issues: Having had good dental health before initiating Suboxone therapy.
- Timing: Developing dental problems after using Suboxone, especially if the usage was before the FDA’s 2022 warning and subsequent label changes.
Potential Compensation and Legal Representation
Plaintiffs in these lawsuits seek compensation for various damages, including:
- Medical Expenses: Costs related to dental treatments, surgeries, and ongoing care resulting from Suboxone-induced dental issues.
- Pain and Suffering: Physical discomfort and emotional distress caused by dental problems.
- Lost Wages: Income lost due to inability to work while undergoing dental treatments or due to dental-related health issues.
While Suboxone remains a critical tool in combating opioid addiction, awareness of its potential dental side effects is crucial. Patients experiencing dental issues believed to be linked to Suboxone use should seek both medical and legal advice to address their health concerns and explore potential compensation avenues. If you or a loved one has used Suboxone and have developed dental issues, we may be able to help. Contact Jacqueline Thomas at Lacy Katzen LLP for a free consultation.
