Suboxone is a popular buprenorphine medication used to treat the symptoms of withdrawal and cravings in those suffering from opioid use disorder (OUD). Upon receiving FDA approval in 2002, the blockbuster drug dominated American markets as its manufacturer, Indivior Inc., reaped considerable profits.
However, Suboxone has been causally linked to a series of severe dental injuries in long-term users, including tooth erosion and decay. Current clinical research indicates that Suboxone’s active ingredient, buprenorphine, drastically lowers pH levels in the mouth and causes the proliferation of harmful oral bacteria. By increasing oral acidity, Suboxone can cause permanent damage to tooth enamel and increase the risk of chronic complications.
It appears that Indivior Incorporated and its former parent company knew of these risks but failed to warn users for two decades. As a result, users of Suboxone have filed numerous product liability lawsuits against the pharmaceutical company and its affiliates which allege that their disregard for user health and safety directly contributed to or caused their injuries.
How Suboxone Works
Suboxone relies upon a complex chemical formula to diminish the otherwise severe symptoms of withdrawal in recovering opioid users. The drug’s active ingredient, buprenorphine, is a partial opioid agonist that binds to the body’s opioid receptors without fully activating them to alleviate withdrawal symptoms and decrease the intensity of cravings. On account of its exclusive FDA approval until 2009, Suboxone became a standard component of recovering opioid users’ medication-assisted treatment (MAT).
Indivior Incorporated has devised several methods of Suboxone administration since the drug’s inception, including implants, injections, and patches. However, transmucosal tablets and films are the primary administrative methods linked to tooth decay and erosion. The recent controversy involving Suboxone revolves around the sublingual administration of the drug.
Buprenorphine Lowers pH Levels in the Mouth
When the FDA issued a 2022 warning about the risk of dental complications in Suboxone users, research centers and physicians across the country began investigating the precise link between buprenorphine and medicinally induced tooth erosion and decay. The primary hypothesis centers on the acidic qualities of buprenorphine.
Oral administration of Suboxone can reduce the mouth’s natural pH level, which refers to the acidity or alkalinity of an environment. If pH levels in the mouth dip below the standard 6.2 to 7.0 threshold, tooth enamel begins to demineralize.
Over the course of several months, chronic damage to tooth enamel can greatly increase an individual’s risk factor of developing an assortment of dental complications. Unfortunately, Indivior failed to inform users of these risks, despite its knowledge of incident reports filed with the FDA beginning in 2007.
Suboxone Linked to Harmful Oral Bacteria
Another probable cause of tooth erosion and decay in Suboxone users is the medication’s propensity to prompt an uptick in Streptococcus mutans. The naturally occurring oral bacteria breaks down sugars while producing potent lactic acid, further contributing to demineralization.
UTHealth Houston School of Dentistry Professor Bing-Yan Wang, DDS, DMSc, PhD, recently received an annual $700,000 grant to research the link between S. mutans and buprenorphine. Professor Wang’s working hypothesis is that oral buprenorphine may increase an individual’s risk of developing dental caries by contributing to unhealthy S. mutans levels.
In the future, similar research will prove critical in the ongoing Suboxone tooth decay lawsuits, which will rely upon extant medical literature to establish the connection between buprenorphine use and dental complications.
Dental Side Effects of Long-Term Suboxone Use
Overall, oral Suboxone has the potential to upset considerably the mouth’s natural chemical balance. Through increasing oral acidity, Suboxone can strip tooth enamel of vital minerals and contribute directly to a variety of dental complications, including:
- Cracked teeth
- Dental caries
- Crown replacements
- Tooth extractions
- Root canals
- Xerostomia (dry mouth)
Suboxone Manufacturer Failed to Warn Users of Dental Complications
The U.S. Food and Drug Adminsitration (FDA) is tasked with assessing and approving prescription medications before they go to market. However, the agency also conducts extensive postmarketing review to determine the safety and efficacy of drugs over time.
One way in which the FDA performs this critical obligation is through fielding adverse event reports (AERs) via its MedWatch digital portal. The FDA began receiving AERs implicating Suboxone in 2007. By 2021, physicians and users alike had submitted a large number of reports in which they allege that the oral buprenorphine drug resulted in unexpected and undisclosed dental complications.
Unfortunately, Indivior Inc. failed to recognize the accessible reports or voluntarily revise Suboxone’s warning label to account for them. As a direct result, users continued to rely upon inaccurate medical information about Suboxone’s safety and efficacy.
FDA Issues Suboxone Warning After Receiving Incident Reports
In response to the growing body of AERs, the FDA issued a Suboxone warning, in January 2022. The agency’s decision cited the unique medical risks associated with oral buprenorphine medications, including oral infections and dental degredation.
The regulatory shift prompted Indivior to include in its side effects disclosure a dental health warning. However, two decades of unmitigated and uninformed use had already resulted in countless dental complications in long-term users.
Indivior Inc.’s History of Malfeasance and Deception
Beginning in the early 2010s, a variety of competing buprenorphine medications received FDA approval, jeopardizing Indivior’s market dominance. In an effort to preserve its gains, the pharmaceutical company resorted to a series of illicit schemes, deceptive marketing strategies, and antitrust violations.
For example, in 2020, Indivior settled a $600 million lawsuit with the United States government, in which it pleaded guilty to one-count felony information. It later settled antitrust violations with the Federal Trade Commission (FTC) for $10 million, in 2021. Subsequent litigation advanced by drug wholesalers concluded with a $385 million payout in October 2023.
The rapidly amassing body of product liability lawsuits against Indivior Inc. represents the beleaguered company’s latest round of legal troubles. Additionally, the extent of Suboxone use throughout the United States has the potential to result in sweeping litigation which could radically alter Indivior’s financial stability.
Common Damages in Suboxone Tooth Decay Lawsuits
The litany of injuries associated with the long-term use of oral Suboxone can result in massive medical costs and debilitating pain or discomfort. Moreover, recovering opioid users may lack sufficient insurance coverage to afford routine and invasive dental procedures, jeopardizing their financial stability.
Fortunately, buprenorphine users reserve the right to seek compensation from Indivior through a Suboxone tooth decay lawsuit in the form of economic and non-economic damages, including:
- Medical expenses – past, present, and future
- Lost wages and income
- Out-of-pocket costs
- Pain and suffering
- Decreased quality of life
- Emotional distress
In order to determine the precise compensation to which you may be entitled, it is imperative to speak with a qualified product liability lawyer. Although various online services claim to provide instantaneous compensation estimates, devising a fair and reasonable figure requires years of experience and an assessment of the unique circumstances of your claim.
Contact an Experienced Product Liability Lawyer for Your Suboxone Lawsuit
Indivior Incorporated and its various affiliates have demonstrated time and again their willingness to endanger users in order to benefit shareholders. The Suboxone manufacturer's unconscionable disregard for the physical and financial well-being of Suboxone users represents a gross betrayal of public trust and illustrates the unethical and illegal business practices of a prominent drug manufacturer.
If you received a prescription for oral Suboxone prior to the Indivior’s 2022 label revision and subsequently developed dental complications, we want to help.
In a free consultation, our qualified Suboxone tooth decay lawyers can determine the eligibility of your claim, calculate the compensation to which you may be entitled, and provide critical advice on whether or how to proceed. Moreover, we work on a contingency-fee basis, which means you don’t pay unless we resolve your case successfully.
With over 120 combined years of personal injury law experience and the resources, track record, and influence to prove it, we maintain a steadfast commitment to defending consumer rights against the recklessness of massive pharmaceuticals.
For more information, contact us online or at 727-451-6900 today.