Lawsuits have been filed by people who used Suboxone and suffered from severe tooth decay, cavities, and other dental problems that required oral surgery.
Need a Texas Suboxone Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you were diagnosed with severe tooth decay after using Suboxone, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Suboxone Lawsuits Centralized in MDL
In February 2024, nationwide Suboxone lawsuits for tooth decay were centralized into a single federal court. The Suboxone MDL is located in the U.S. District Court for the Northern District of Ohio under Judge J. Philip Calabrese — IN RE: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation — Case Number 1:24-md-03092.
What is Suboxone?
Suboxone® (buprenorphine and naloxone) is a medication that was approved in 2002 to help reduce withdrawal symptoms in opioid addicts while they undergo therapy to break their addiction. Suboxone is taken as a film strip that dissolves under the tongue or in the cheek.
What is the Problem?
Hundreds of people have suffered from tooth decay and other severe dental problems after using Suboxone. The problem is that the ingredients in Suboxone, buprenorphine and naloxone, are very acidic. When dissolved in the mouth, Suboxone creates acidic conditions that can damage tooth enamel and lead to cavities.
FDA Updates Suboxone Warnings After 300 Reports of Tooth Decay
The FDA ordered drug-makers to update the warning label on Suboxone after more than 300 patients reported tooth decay and other dental problems, including patients with no previous history of dental problems.
Most patients were in their 40s, but tooth decay was also reported in patients as young as 18 years old. In some reports, tooth damage occurred only 2 weeks after patients started Suboxone.
Suboxone Lawsuits Claim Drug-Maker Did Not Warn About Risk
The pharmaceutical companies who make Suboxone are facing lawsuits from patients who developed severe tooth decay, cavities, or other dental problems that required extensive dental work. Lawsuits accuse drug-makers of failing to add warnings about dental problems to the medication guide that is most commonly given to patients.
Does Suboxone Rot Your Teeth?
Suboxone is acidic, with a pH of 3.4 when dissolved in water. It also causes dry mouth, which can make conditions in mouth even more acidic. Tooth enamel dissolves when the pH in the mouth is too acidic (under 5.5). Over time, repeated exposure to the acidic ingredients in Suboxone can severely damage the tooth enamel and cause cavities.
Suboxone Users At Risk of Dental Cavities
Exposure to the acidic ingredients in Suboxone can damage the tooth enamel, which is the tooth’s protective outer layer. Tooth enamel demineralizes (loses minerals) when it is exposed to acids, becoming too weak to protect the teeth from harmful bacteria that cause cavities.
Signs & Symptoms of Cavities
Cavities are permanently damaged areas of the teeth that become pits or holes. They can cause painful toothaches, infection, and tooth loss. The symptoms may include:
- Toothache or pain
- Sensitive teeth
- Mild or sharp pain when eating or drinking
- Visible holes or pits in the teeth
- Tooth stains are brown, black, or white
- Pain when biting down
FDA Warning for Suboxone and Tooth Decay
On January 12, 2022, the FDA issued a Safety Communication to warn about the risk of severe tooth decay from Suboxone.
Around 40% of the adverse events that were reported to the FDA were classified as “serious,” with more than one-third of cases involving at least two teeth. According to the FDA:
“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.”
The FDA also required a new warning about dental problems on the Prescribing Information for Suboxone and the patient Medication Guide for all buprenorphine medicines that are dissolved in the mouth.
What is the Risk?
Suboxone is linked to severe dental problems, such as:
- Tooth decay
- Cavities
- Tooth loss
- Chipped and rotting teeth
- Broken teeth
- Oral surgery
- Needing to have teeth pulled
- Dental abscesses / infection
- Tooth erosion
- Gum disease (periodontitis)
- Filling falling out
- Other dental problems
Treatments for Tooth Problems Linked to Suboxone
The treatments for dental problems linked to Suboxone may include tooth extraction, root canal, dental surgery, and other restorative procedures (i.e., fillings, crowns, implants, dentures, and more).
Major Study Links Suboxone and Dental Problems
In December 2022, the long-term use of Suboxone was linked to a doubled increased risk of dental problems in a major study that was published in JAMA.
The study involved 21,404 people who used buprenorphine and naloxone combination drugs. They found that patients who used sublingual (under-the-tongue) versions like Suboxone were twice as likely to develop dental problems, severe cavities, or lose their teeth.
According to the researchers, out of every 1,000 people who used under-the-tongue Suboxone, about 21.6 developed dental problems.
The authors of the study warned:
“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.”
What Is Suboxone Used For?
Suboxone® (generic: buprenorphine and naloxone) is an anti-opioid medication that decreases withdrawal symptoms in people who are addicted to opioids. Suboxone is one of the main prescription medications that is used to treat opioid use disorders and addiction.
What is in Suboxone?
Suboxone contains a combination of two medications: buprenorphine and naloxone. Naloxone can rapidly reverse an opioid overdose. Buprenorphine is an opioid partial-agonist, which means that it can produce mild effects that are similar to other opioids (such as euphoria or respiratory depression), but with a lower risk of abuse or addiction.
How Do Patients Use Suboxone?
Suboxone can be taken as a sublingual table or a film strip that dissolves in the mouth. Patients place the tablet or film under their tongue for 5 to 10 minutes. Suboxone can also be placed on the inside of the cheek until it is completely dissolved.
Have Suboxone Lawsuits Been Filed by People With Tooth Decay?
Yes. Lawsuits claim that the manufacturers of Suboxone knew about the risk of tooth decay long before the FDA issued warnings, but the drug-makers failed to warn patients.
Who Are Suboxone Lawsuits Being Filed Against?
Suboxone lawsuits for tooth decay are being filed against Indivior Inc. and its subsidiaries, including Aquestive Therapeutics, MonoSol Rx, Inc. and Reckitt Benckiser LLC.
Can I Join a Class Action Lawsuit?
There has not yet been a class action lawsuit filed against the makers of Suboxone for people with tooth decay injuries. Instead, our law firm is pursuing individual lawsuits for people who were harmed by Suboxone. The plaintiffs are seeking damages for their pain and suffering, medical expenses, permanent disfigurement, and more.
Need a Suboxone Tooth Decay Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.
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