The Bitter Side of Recovery: Suboxone Lawsuits Shed Light on Severe Dental Damage

Suboxone, a widely prescribed medication for opioid use disorder (OUD), is due to its association with severe dental problems. In early 2024, the U.S. Judicial Panel on Multidistrict Litigation centralized over a dozen lawsuits into a multidistrict litigation (MDL) in the Northern District of Ohio, overseen by Judge J. Philip Calabrese. These lawsuits allege that Suboxone’s sublingual formulation leads to tooth decay, erosion, and loss, and that manufacturers failed to warn patients and healthcare providers about these risks adequately.

The Dental Impact of Suboxone

Suboxone’s sublingual administration means the medication dissolves under the tongue, allowing its active ingredients—buprenorphine and naloxone—to be absorbed through the oral mucosa. However, this method exposes teeth to the drug’s acidic components for extended periods. Suboxone contains acidic inactive ingredients such as citric acid and sodium citrate dihydrate to maintain stability and effectiveness. The medication’s pH level is approximately 3.4, significantly lower than the threshold at which tooth enamel begins to demineralize (pH 5.5)

Additionally, Suboxone use has been linked to xerostomia, or dry mouth, a condition that reduces saliva production. Saliva plays a crucial role in neutralizing acids and protecting teeth from decay. A 2013 study found that buprenorphine users had approximately 50% lower saliva levels, increasing their risk for dental caries.

FDA Warnings and Manufacturer Response

In January 2022, the FDA issued a warning about dental problems associated with buprenorphine medicines dissolved in the mouth, including Suboxone. Reported issues included cavities, tooth decay, dental abscesses, and tooth loss, even in patients with no prior history of dental problems. The FDA recommended that healthcare providers screen patients for oral disease before starting treatment and advise them on maintaining oral hygiene during therapy.

Despite these warnings, plaintiffs argue that manufacturers like Indivior and Aquestive Therapeutics failed to provide adequate information about the risks, especially considering that the FDA had received reports of tooth damage related to Suboxone as early as 2006.

Legal Developments

As of early 2025, the Suboxone MDL has grown to include over 700 cases. In January 2025, Judge Calabrese ruled on a motion to dismiss, allowing key claims such as failure to warn and design defects to proceed against the manufacturer. However, design defect claims for cases post-2010 were dismissed. The litigation is now entering a phase focused on discovery, expert testimony, and potential bellwether trials.

Managing Dental Health During Suboxone Treatment

For patients undergoing Suboxone therapy, proactive dental care is essential. Recommendations include:

Regular Dental Checkups: Inform your dentist about your Suboxone use so they can monitor for early signs of decay.
Oral Hygiene Practices: Rinse your mouth with water after the medication has dissolved and wait at least an hour before brushing to avoid enamel damage.
Saliva Substitutes: Use products like xylitol gum or mouth sprays to combat dry mouth and maintain saliva flow.
Fluoride Treatments: Consider high-fluoride toothpaste or professional fluoride varnishes to strengthen enamel.

Conclusion

While Suboxone remains a critical component in treating opioid use disorder, awareness of its potential dental side effects is crucial. Patients should engage in preventive dental care and consult healthcare providers about any concerns. As legal proceedings continue, further information may emerge regarding the responsibilities of manufacturers in warning about these risks.