Update: Suboxone Lawsuit Filed Over Tooth Decay, Damage
The first Suboxone Tooth Decay Lawsuit was filed in the Northern District of Ohio in September 2023 by an Ohio man who claims that Suboxone causes tooth decay and permanent dental damage, due to its high acidity.
The complaint was filed by Plaintiff David Sorensen, who allegedly became addicted to opioids after using them for pain management, and was subsequently prescribed Suboxone to treat his addiction. As a result of his use of Suboxone, Sorensen now suffers from permanent tooth decay and has needed to undergo extensive dental work as a result, according to the lawsuit.
The lawsuit indicates that the manufacturer knew about the Suboxone tooth decay risks long before the FDA warning, but failed to adequately warn of this risk. By the end of 2010, the manufacturer had submitted at least 20 reports to the FDA regarding tooth decay associated with the use of Suboxone.
Additionally, Sorensen claims that the manufacturer changed the Suboxone prescribing information to add warnings about the risk of dental problems, but did not add it to the medication guide, which is most commonly seen by patients.
The complaint lists Indivior, Inc., Aquestive Therapeutics, MonoSol Rx, Inc., and Reckitt Benckiser LLC as defendants.
Suboxone Linked to Severe Dental Problems: FDA Warning
The U.S. Food and Drug Administration (FDA) on January 12, 2022, issued a warning [1.] 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. The FDA noted that many of these issues occurred in patients with no prior dental issues.
As a result of these problems, the FDA is requiring a new warning about the risk of dental problems to be added to the prescribing information [2.] and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth. The prescribing and patient information will also include strategies to maintain or improve oral health while undergoing treatment with these medicines, the FDA said.
What is Suboxone?
Suboxone is a prescription medication used to treat Opioid use disorder (OUD). It contains 2 medications, Buprenorphine and Naloxone. These drugs work by tricking the brain into thinking that it is receiving a full dose of an opioid, while naloxone blocks the activation of opioid receptors, thereby reversing the euphoric effects of buprenorphine. Suboxone is manufactured and marketed by Indivor and was approved by the U.S. Food and Drug Administration (FDA) in October 2002.
Suboxone Side Effects
Serious dental side effects of Suboxone include:
- Tooth decay
- Cracked teeth
- Oral infections
- Tooth loss
- Dental Caries (loss of enamel, dentine, and other tooth substances)
- Root canal
- Tooth extraction
- Crown replacement
Other, more common Suboxone side effects may include:
- Opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
- Insomnia (trouble sleeping)
- Weakness or fatigue
- Back pain
- Burning mouth syndrome (burning sensation of the mouth or tongue)
- Redness in the mouth
What are Suboxone Lawsuits Alleging?
The original labeling on Suboxone carried no warnings regarding the risk of tooth decay associated with its prescribed use. However, Suboxone tooth decay lawsuits allege that the manufacturers were well aware of the tooth decay risk prior to finally warning about it on the product's labeling in January 2022.
In December 2022, the Journal of the American Medical Association (JAMA) published a study [3.] that looked at sublingual Suboxone and dental adverse events.
For the study, the researchers took a random sample of patients from 2006 to 2020 who were registered in the PharMetrics database (IQVIA), and created a cohort of new users of sublingual Suboxone and 2 active comparator groups (used for opioid use disorder) -- new users of either transdermal buprenorphine or oral naltrexone. A total of 21, 404 new users of sublingual buprenorphine/naloxone, 5,385 users of transdermal buprenorphine, and 6,616 users of oral naltrexone were identified and included in the study.
The researchers found an increase in the risk of adverse dental outcomes linked to sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone. 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.
An October 2013 case report published in The Primary Care Companion [4.] described a patient who experienced a sudden decline in oral health while using Suboxone tablets. The patient, who had been prescribed Suboxone for Opioid Use Disorder, required extensive dental treatment for decay in multiple teeth after 18 months of taking Suboxone. The researchers concluded that chronic use of sublingual Suboxone likely played a role in the patient’s dental decline.
The lead researcher in the report, along with other Harvard colleagues, went on to publish a case series featuring 11 patients who experienced worsening dental health after beginning treatment with Suboxone at Brigham and Women’s Hospital in Boston. All of the patients encountered dental caries, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The study's authors noted that dental cavities and tooth erosion occur in environments with low pH levels.
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Get a Free Suboxone Tooth Decay Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Suboxone Tooth Decay Lawsuits. We are handling individual litigation nationwide and are currently accepting new dental Suboxone Side Effects cases in all 50 states.
Again, if you or a loved one experienced tooth decay after using Suboxone, or suffered from other dental Suboxone side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and our lawyers can help.