Suboxone Tooth Decay Litigation

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Suboxone, manufactured by Indivior and Reckitt Benckiser, is a medication used for treating opioid use disorder. However, in 2022, the Food and Drug Administration issued a warning to the public that dental decay and destruction have been reported with medicines containing buprenorphine that are dissolved in the mouth. The acidic nature of Suboxone, coupled with its administration inside the cheek (buccal route) or under the tongue (sublingual route), has been linked to adverse dental events such as cavities, tooth decay/destruction, and tooth loss. Lawsuits filed against Indivior and Reckitt Benckiser aim to hold the companies accountable for failing to warn patients about the risk of severe dental issues and provide compensation to those who have experienced these injuries after using Suboxone.

The attorneys at Sbaiti & Company have extensive experience in mass tort litigation and have represented tens of thousands of clients seeking justice for injuries caused by negligent companies, just like Indivior and Reckitt Benckiser.

Symptoms:
  • Dental caries (i.e., decay and cavities)
  • Tooth loss
  • Bruxism (teeth grinding)
  • Necrotizing ulcerative gingivitis
  • Periodontitis
  • Xerostomia (dry mouth)
  • Oral papilloma
  • Candidiasis
Suboxone linked to tooth decay

The link between Suboxone use and adverse dental events is supported by a growing body of scientific evidence, shedding light on the mechanisms underlying these health issues:

Suboxone tablets and films have an acidic pH that increases the absorption of buprenorphine and naloxone into the bloodstream.

Suboxone’s medication guide instructs patients to hold the Suboxone tablets or film under their tongue or against their cheek for several minutes to enhance absorption. This prolonged exposure to the acidic substance can alter the oral pH balance (the normal pH range is 6-7), potentially leading to enamel erosion and dental decay/cavities.

Buprenorphine, the primary active ingredient in Suboxone, exerts its analgesic effect by binding to mu-opioid receptors in the central nervous system.

Naloxone, an opioid antagonist present in Suboxone, acts to deter misuse of the formulation by preventing intravenous administration.

The design of both the tablets and film makes the mouth more acidic than normal because both medications require an acidic environment for full drug absorption.

Studies, such as those published in medical journals like The Journal of the American Medical Association (JAMA), have reported a link between Suboxone use and dental adverse events, including caries and tooth loss.

The findings suggest a higher risk of dental disorders among both tablet and film Suboxone users, compared to buprenorphine patches or oral naltrexone.

Research has proposed several mechanisms through which Suboxone may contribute to dental decay, including:
a. Disruption of oral pH balance may lead to enamel erosion and susceptibility to cavities.
b. Immunosuppressive effects may compromise the body’s ability to defend against oral pathogens by killing normal, healthy bacteria.
c. Reduced salivary flow may worsen the effects of acid exposure and increase the risk of dental erosion.

Key Dates and Timeline
Buprenorphine, the primary active ingredient in Suboxone, begins development for its analgesic and opioid addiction treatment properties.
Clinical trials evaluating the efficacy and safety of buprenorphine for opioid addiction treatment commence, laying the groundwork for its eventual approval.
Suboxone sublingual tablets containing buprenorphine and naloxone receive FDA approval for the treatment of opioid use disorder (OUD).
Indivior receives FDA approval for Suboxone sublingual film, providing an alternative formulation for patients requiring opioid addiction treatment.
Reckitt Benckiser Pharmaceuticals Inc., the manufacturer of Suboxone tablets, voluntarily discontinues the supply of Suboxone tablets in the United States due to fraudulent concerns about increased pediatric accidental ingestion.
Indivior separates from its parent company, Reckitt Benckiser Group PLC, and becomes an independently traded company. This move marks the establishment of Indivior as a standalone company focused exclusively on opioid addiction treatment.
Indivior Solutions pleads guilty to felony charges involving allegations of misleading marketing practices related to Suboxone. Indivior, along with its former parent company, the Reckitt Benckiser Group, agrees to pay more than $2 billion in fines—the largest financial penalty imposed on any pharmaceutical company involving opioid-related charges.
The U.S. Food and Drug Administration (FDA) alerts healthcare professionals regarding the potential risk of dental adverse events, including dental damage, destruction, and tooth loss, associated with long-term use of tablet or film formulations of buprenorphine (typically combined with naloxone). This alert raises concerns about the negative long-term oral health effects of Suboxone use.
Research continues to address the relationship between Suboxone use and adverse dental events, while Suboxone users begin filing lawsuits against its manufacturers. Patients experiencing dental issues related to Suboxone use may seek legal recourse for compensation and accountability. Healthcare providers should emphasize the importance of monitoring and addressing the oral health of patients undergoing Suboxone therapy.
Why Sbaiti & Company

Sbaiti & Company, a boutique law firm with offices in Texas and New Jersey, focuses on significant mass tort litigation and appeals. Our team comprises seasoned lawyers who have previously practiced at larger firms but now prefer the agility and personalized service that a boutique environment offers. Based in Dallas, our reach extends nationally and internationally, allowing us to serve clients effectively wherever they may be.

Clients choose Sbaiti & Company because of our track record of success and dedication to delivering tailored legal strategies. With experience representing plaintiffs across various areas, we offer a comprehensive understanding of complex litigation dynamics. Whether stepping in to resolve contentious matters, navigating trials, or handling post-trial appeals, our team is committed to achieving favorable outcomes for our clients. We prioritize clear communication, rapid responses to client concerns, and meticulous research and analysis, ensuring that our legal counsel is informed, strategic, and aligned with our clients’ objectives.

Mazin bw1
Mazin A. Sbaiti

Founding Partner

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Asim M. Badaruzzaman

Partner

Sources:

  1. https://www.prnewswire.com/news-releases/reckitt-benckiser-pharmaceuticals-inc-announces-plans-to-rebrand-under-indivior-plc-following-demerger-245324987.html
  2. https://www.justice.gov/opa/pr/justice-department-obtains-14-billion-reckitt-benckiser-group-largest-recovery-case
  3. https://www.justice.gov/opa/pr/indivior-solutions-pleads-guilty-felony-charge-and-indivior-entities-agree-pay-600-million
  4. https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines#:~:text=ISSUE%3A%20The%20FDA%20is%20warning,no%20history%20of%20dental%20issues.
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