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Update: Suboxone Lawsuit Filed Over Tooth Decay, Damage
Defendants knew or should have known that Suboxone when used as prescribed and intended, causes harmful damage to the teeth due to the acidity of buprenorphine, – the complaint states.
Suboxone Linked to Severe Dental Problems: FDA Warning
The FDA issued a warning on January 12, 2022, which stated that severe dental problems have been reported in patients using Suboxone and other buprenorphine-containing tablets and films [2].
The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth, – the FDA said. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.
According to the FDA warning from 2022, the agency requires 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. The prescribing and patient information will also include strategies to maintain or improve oral health while undergoing treatment with these medicines [3].
What is Suboxone?
Suboxone is a prescription medication used to treat Opioid use disorder (OUD). It contains 2 medications, Buprenorphine and Naloxone.
As stated by a Harvard Health Publishing study from 2021, 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 [4]. 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
According to a MedicalNewsToday article from 2022 [5], serious dental side effects of Suboxone include:
- Tooth decay
- Cracked teeth
- Cavities
- 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:
- Headache
- Opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
- Anxiety
- Insomnia (trouble sleeping)
- Sweating
- Depression
- Constipation
- Nausea
- Weakness or fatigue
- Back pain
- Burning mouth syndrome (burning sensation of the mouth or tongue)
- Redness in the mouth
What are Suboxone Lawsuits Alleging?
According to Reuters, 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 [6].
Suboxone Studies
In December 2022, the Journal of the American Medical Association (JAMA) published a study that looked at sublingual Suboxone and dental adverse events [7].
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.
This study found an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone, the researchers concluded. Sublingual buprenorphine/naloxone is acidic in nature. Patients are instructed to hold the tablet under the tongue for 5 to 10 minutes to maximize absorption. Thus, prolonged acidic exposure of the drug in the mouth might lead to tooth damage.
An October 2013 case report published in The Primary Care Companion, described a patient who experienced a sudden decline in oral health while using Suboxone tablets [8].
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.
Buprenorphine used for addiction treatment is given sublingually, and the properties of this treatment may have a direct and adverse effect on dentition, the study’s authors said. The prolonged contact between tooth surfaces with buprenorphine/naloxone, therefore, may be a contributing factor in the alteration of tooth surface microbial profile and/or the pH to promote dental caries, similar to what has been previously reported in patients who use methamphetamine.
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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FAQs
How Does Suboxone Cause Tooth Decay?
Suboxone can cause dry mouth, reducing saliva production, which is essential for maintaining oral health. This leads to an increased risk of tooth decay and other dental problems. Long-term use and poor oral hygiene can exacerbate these issues.
Who Can File a Suboxone Tooth Decay Lawsuit?
Individuals who have experienced significant dental problems, including tooth decay and loss, due to Suboxone use may be eligible to file a lawsuit. Affected individuals should consult a lawyer to assess their case and potential for compensation.
What Compensation Is Available in a Suboxone Tooth Decay Lawsuit?
Compensation in a Suboxone tooth decay lawsuit may include costs for dental treatments, pain and suffering, lost wages, and other related expenses. The specific amount varies based on the severity of the dental issues and the impact on the individual’s life.
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.
References:
- https://dockets.justia.com/docket/multi-district/jpml/MDL%20NO.%203092/1673048
- https://www.fda.gov/media/155352/download?attachment
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf#page=35
- https://www.health.harvard.edu/blog/5-myths-about-using-suboxone-to-treat-opiate-addiction-2018032014496
- https://www.medicalnewstoday.com/articles/325827
- https://www.reuters.com/legal/indivior-pay-385-mln-end-suboxone-monopoly-lawsuits-2023-10-23/
- https://jamanetwork.com/journals/jama/fullarticle/2799415
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907320/