Studies Link Oral Suboxone Use to Tooth Erosion and Decay

Studies Link Oral Suboxone Use to Tooth Erosion and Decay

In an effort to facilitate the treatment of opioid use disorder (OUD), the Food and Drug Administration has approved a series of medications since the early 2000s. One of the most ubiquitous drugs in medication-assisted treatment (MAT) is Suboxone, which decreases the symptoms of withdrawal while diminishing the intensity of cravings. 

Although regulatory agencies and physicians praise the benefits of Indivior’s buprenorphine-naloxone medication, they also cite extensive clinical research that indicates that the drug has the potential to cause severe dental complications. However, the manufacturer and its close affiliates failed to disclose these risks to users, prompting a series of Suboxone tooth decay lawsuits in recent months.

Researchers have been investigating the link between oral Suboxone administration and tooth erosion and decay for nearly ten years. Alongside user reports from the FDA’s MedWatch database and plaintiff testimonials, extant medical literature will assist plaintiffs in establishing Indivior’s negligence. 

If you received an oral buprenorphine prescription and later suffered dental issues, contact us today

The Importance of Medical Literature in Product Liability Lawsuits

In product liability litigation, clinical research assumes an important role in establishing that a liable manufacturer either knew or ought to have known of the risks its medication posed. A subsequent “failure to warn” users of these risks may constitute a breach of duty of care, especially if it resulted in extensive injuries. 

There are three primary hypotheses that extant clinical research advances to explain the mechanism by which oral Suboxone use causes dental complications. Although additional research is necessary to establish a clinical consensus, peer-reviewed studies have already discovered that oral buprenorphine-naloxone can cause: 

  • Increased oral acidity
  • Decreased salivary flow and buffering
  • Virulence of Streptococcus mutans 

The ongoing Suboxone tooth decay lawsuits will likely cite a decade's worth of medical literature investigating the causal link between oral buprenorphine-naloxone use and dental issues, including: 

Case Series of Suboxone Use in Recovering Opioid Users 

A 2013 case series from The Primary Care Companion for CNS Disorders surveyed the rapid dental decline of eleven recovering opioid users receiving treatment at Brigham and Women’s Hospital, in Boston. In contrast to the general population, over 90% of the oral buprenorphine recipients displayed low to moderate salivary buffering. 

Salivary flow assumes a crucial role in the regulation of oral pH levels. If inhibited, levels of acidity in the mouth can spike and seriously damage the protective layer of enamel coating the teeth. On account of the study’s limited design, researchers refrained from definitively confirming the link between Suboxone and dental decay. 

Nevertheless, there is a high probability that oral buprenorphine worsens preexisting dental problems, and Indivior’s refusal to properly inform users of the risk constitutes a breach of duty of care. 

Dental Caries Linked to Suboxone Use in 2017 Survey

One of the potential side effects of oral Suboxone use is xerostomia (dry mouth), which can result in heightened oral acidity. In more advanced cases, dry mouth can contribute to demineralization and tooth decay

In 2017, researchers confirmed the buprenorphine-xerostomia link in a study relying upon information through the VigiBase database. Identifying the risk of dental caries in 88 medications, the analysis referenced the alarming reduction of salivary flow in oral Suboxone users

Peer-Reviewed JAMA Research Identifies Dental Issues in Suboxone Users

The largest and most authoritative Suboxone study was published in a 2022 edition of the Journal of the American Medical Association (JAMA). Researchers in the study created three cohorts composed of recovering opioid users taking, transdermal buprenorphine, oral buprenorphine-naloxone, and oral naltrexone. 

The study would monitor participants’ progress for one year and gather data that indicated that users of sublingual Suboxone displayed higher rates of tooth loss and dental caries than the other cohorts in the study. While this data indicated a strong tie between sublingual buprenorphine use and tooth decay, correlation can not be grounds for conclusion. Since other variables that could contribute to increased rates of tooth decay and tooth caries like soda consumption, cigarette smoking, and poor dental hygiene could not be accounted for in the cohorts, the study could not conclusively say that sublingual buprenorphine was the main cause of tooth decay among that cohort.

However, the study’s findings corroborated earlier discoveries and confirmed suspicions that oral buprenorphine-naloxone could catalyze dental decline. 

2023 Analysis of Oral Suboxone Adverse Event Reports

Adverse event reports (AERs) are one of the primary tools the FDA uses to monitor the drugs they have approved for issues. Consumers and physicians who prescribe FDA-approved drugs are able to file AERs in the event that the drug causes some severe side effects such as tooth decay.

Several researchers in 2023 analyzed the public Suboxone AERs, revealing an unnerving pattern of dental complications. The Current Drug Safety study published by said researchers discovered that buccal and sublingual Suboxone use accounted for a “disproportionate reporting of dental disorders” in submissions from 2015 to 2021. 

The latest hypothesis to describe the mechanism by which oral Suboxone causes dental decay asserts that the medication can increase the virulence of Streptococcus mutans. The naturally occurring oral bacteria quickly metabolizes sugars and produces lactic acid, which damages tooth enamel. 

With appropriate dental hygiene, S. mutans levels do not pose serious risks to overall dental health. However, Professor Bin-Yan Wang of UTHealth postulates that oral buprenorphine can drastically increase the presence of Streptococcus mutans and result in dental caries. 

Professor Wang recently received a $700,000 federal grant from the National Institutes of Health to investigate the link. Although largely preliminary, the study may assume a crucial role in the pending Suboxone tooth decay lawsuits, which will cite extant and novel research to prove that Indivior Inc. either knew or ought to have known about the inherent risks of oral buprenorphine use. 

How Does Oral Suboxone Buprenorphine Work? 

Buprenorphine-naloxone relies upon a semisynthetic opiate that binds to the brain’s mu receptors. These receptors are responsible for neuromodulation of many of the body's functions. More relevantly, mu receptors can decrease the intensity of opioid withdrawal symptoms and cravings. Indivior Incorporated initially produced an oral Suboxone tablet but would go on to invest in the development of alternative methods of administrating the drug when their market exclusivity ended in 2009

At the center of the ongoing Suboxone tooth decay lawsuits are sublingual and buccal films, which dissolve slowly in the mouth and have the potential to result in heightened oral acidity. In the absence of sufficient dental hygiene and routine examinations, long-term oral Suboxone use can result in serious dental complications, including: 

  • Crown replacements
  • Tooth extractions 
  • Dental fillings 
  • Cracked teeth 
  • Dental caries 
  • Root canals

Regulatory Intervention Prompts Suboxone Warning Label Revision

After receiving hundreds of oral Suboxone adverse event reports, the FDA issued a public warning in January 2022. Although the agency’s press release notes the benefits of oral buprenorphine in medication-assisted treatment of opioid use disorder, it also encourages users to familiarize themselves with the dental risks of the medication. 

Indivior Incorporated refrained from voluntarily revising the Suboxone safety label to account for tooth erosion and decay, which led the FDA to issue a mandatory revision in June 2022. The development signaled a looming shift in the public’s perception of Indivior’s famous medication in the midst of extensive litigation pertaining to the company’s antitrust violations and laid the groundwork for personal injury litigation. 

Who Is Eligible to File a Suboxone Tooth Decay Lawsuit? 

Oral buprenorphine-naloxone has been used in a variety of forms for two decades and remains widespread in spite of recent legal and regulatory scrutiny. Consequently, the number of Suboxone tooth decay lawsuits is likely to increase exponentially in the coming months, especially in the wake of a petition to create a multidistrict litigation. 

In order to qualify for a Suboxone tooth decay lawsuit, oral buprenorphine-naloxone users must satisfy the following criteria: 

  • Oral Suboxone prescription prior to June 2022
  • Dental complications after Suboxone use
  • Valid claim under applicable statutes of limitation

A failure to file suit within the legal timeframe outlined in your state’s statute of limitations for product liability litigation could prevent you from acquiring the accountability and compensation you deserve. 

Common Damages in Suboxone Buprenorphine Lawsuits

Indivior’s unjustifiable failure to warn oral Suboxone users of the drug’s risks has cost many their peace of mind, thousands of dollars in medical and dental bills, and vital stability as they recover from opioid dependence. Fortunately, these losses may be compensable in a court of law. 

Filing a Suboxone tooth decay lawsuit enables the victims of Indivior’s unethical marketing practices to seek financial assistance in the form of economic and non-economic damages, including: 

  • Medical costs – past, present, and future
  • Lost wages and income
  • Out-of-pocket expenses
  • Pain and suffering
  • Decreased quality of life 
  • Emotional anguish

There are a variety of online resources and services that claim to provide immediate compensation estimates for Suboxone lawsuit settlements. However, every case and claim is unique, which means that the best way in which to calculate entitlements is to speak with a qualified Suboxone tooth decay lawyer today. 

Contact an Experienced Product Liability Lawyer for Your Suboxone Tooth Decay Lawsuit

Indivior Incorporated owed a duty of care to Suboxone users but routinely ignored the clinical research and FDA adverse event reports linking the medication to undisclosed health risks. Given Indivior’s history of malfeasance, the disturbing revelations are only the latest to illustrate the pharmaceutical company’s willingness to endanger the public in order to preserve its profits. 

In recent months, over 100 Suboxone tooth decay lawsuits have been filed in various courts throughout the country. Our talented legal team of Suboxone tooth decay lawyers is closely watching these developments and is on standby to offer advice and counsel to prospective clients. 

In a free consultation, we can explain the eligibility of your claim, calculate the compensation to which you may be entitled, and advise you on how best to proceed. With considerable experience in defective drug litigation involving Tylenol, Uloric, Ozempic, and Tepezza, we know how to craft compelling claims and advocate tirelessly on our clients’ behalf. 

For more information and assistance, contact us today


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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