Suboxone lawsuits are being filed for tooth decay and other dental problems.
- Suboxone is currently manufactured by Indivor, Inc., a former division of the British pharmaceutical company Reckitt Benckiser.
- The original labeling on Suboxone carried no warnings regarding the risk of tooth decay associated with its prescribed use.
- Suboxone is highly acidic when dissolved, and high acid levels are known to damage tooth enamel.
- By January of 2022 the U.S. Food and Drug Administration (FDA) indicated there had been more than 300 cases of tooth decay and dental problems reported by Suboxone users.
- On January 12, 2022, the FDA issued a warning which stated that severe dental problems have been reported in patients using Suboxone.
- The manufacturers finally added additional label warnings as required by the FDA.
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You could be entitled to compensation for your dental injury from Suboxone!
Risk of Dental Injuries Related to
Suboxone Use Include:
Our attorneys are currently reviewing potential claims related to Suboxone use which contain buprenorphine and naloxone.
Medications containing buprenorphine designed to dissolve in the mouth can lead to dental problems, according to a drug safety communication issued by the FDA on January 12, 2022.
Lawsuits are being filed against the manufacturer of Suboxone across the country for the following injuries:
- Bone loss in the jaw
- Broken teeth
- Cavities
- Cracked teeth
- Crown replacement
- Dental Caries (loss of enamel, dentine, and other tooth substances)
- Oral infections
- Required dental implants
- Root canal
- Root decay
- Tooth abscess
- Tooth decay
- Tooth extraction
- Tooth fractures
- Tooth loss
- Underwent oral surgery
- Other serious tooth issues
Suboxone History
Suboxone (buprenorphine and naloxone) is a drug approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.
Suboxone was first approved as a tablet to be taken under the tongue to treat opioid addiction. In 2015, it was approved as a film to be placed inside the cheek to treat pain.
Suboxone is currently manufactured by Indivor, Inc., a former division of the British pharmaceutical company Reckitt Benckiser.
In 2019, the Department of Justice indicted Indivor, Inc., for false marketing claims and a scheme to direct patients to doctors who were likely to prescribe Suboxone.
The FDA Warns of Severe Dental Problems Related to Suboxone in 2022.
The U.S. Food and Drug Administration (FDA) on January 12, 2022, issued a warning which stated that severe dental problems have been reported in patients using Suboxone and other buprenorphine-containing tablets and films. Reported side effects of Suboxone included tooth decay, cavities, oral infections, and loss of teeth.
As a result, the FDA is requiring a new warning about the risk of dental problems to be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.
Up until 2022, no form of the Suboxone drugs contained any warning about tooth decay or dental problems.
At the time, the FDA indicated there had been more than 300 cases of tooth decay and dental problems reported among patients using orally dissolvable buprenorphine medications on an annual basis.
Study Shows Dental Problems
Related to Suboxone
In December 2022, the Journal of the American Medical Association (JAMA) published a study that looked at sublingual Suboxone and dental adverse events.
The researchers took a random sample of patients from 2006 to 2020. Over 31,000 users were identified and included in the study.
The study found an increase in the risk of adverse dental outcomes.
Sublingual buprenorphine/naloxone is acidic in nature, so the authors concluded that prolonged acidic exposure of Suboxone in the mouth might lead to tooth damage.
PH Acid Level and Suboxone
Suboxone has a low pH, with a value of 3.4 when dissolved in water.
The pH scale measures acidity or alkalinity, ranging from 0 to 14. A pH of 7 is neutral, while values below 7 indicate acidity and above 7 indicate alkalinity.
The mouth naturally maintains a slightly acidic pH, usually between 6.2 and 7.0.
Tooth enamel, the protective outer layer of teeth, demineralizes (loses minerals) when exposed to acids.
When the mouth’s pH becomes too acidic (below 5.5), it creates conditions where enamel starts to dissolve, a process called demineralization.
Frequent exposure to acidic conditions weakens tooth enamel over time, making it more vulnerable to decay.
The manufacture of Suboxone has been in trouble before.
Suboxone was originally designed as a dissolving pill. In 2009, just before the patent exclusivity expired, which would allow for generic versions of Suboxone, the manufacturer introduced a dissolving film version.
The FDA approved the film version of Suboxone in August 2010. This gave the manufacturer another three years of exclusivity until August 2013. Just a month before that patent exclusivity expired, the manufacturer presented another version of the drug.
The states and federal government accused the manufacturer of submitting a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns.
However, regulators determined that, in actuality, the manufacturer sought to control supply and improperly inflate Suboxone pricing, including what state Medicaid programs paid for it.
In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations.
Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing.
Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia
The settlement resolves allegations of violations of state and federal antitrust laws related to market exclusivity for Suboxone. Furthermore, the manufacturer is prohibited from engaging in future anticompetitive conduct.
What does this have to do with dental injury lawsuits? Well, it underscores what lies within every Suboxone lawsuit: Invidior, and the other defendants put profits ahead of the law and informing the consumer.
Other articles regarding the risks of Suboxone
FDA Warns About Dental Problems with Buprenorphine
FDA Full Prescribing Information for Suboxone
JAMA Study Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease
National Library of Medicine Sublingual Buprenorphine and Dental Problems: A Case Study
FREE Evaluation for your Suboxone Dental Injury Case
What You Can Do & How We Can Help
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At Aaronson and Rash, PLLC, our attorneys are here to help you. We have over 40 years of combined experience in personal injury, environmental disasters, defective products, pharmaceutical litigation, and toxic exposure cases. Our legal team is ready to work with you and your family as we fight for the maximum compensation you deserve.
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Justice for Suboxone Victims
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