Suboxone Tooth Decay Lawsuit

The FDA is warning that the Opioid Use Disorder (OUD) medication Suboxone has recently been linked to serious dental side effects including tooth decay, cavities, oral infections, and even tooth loss.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Suboxone induced injury cases in all 50 states. If you or somebody you know was diagnosed with severe tooth decay after using Suboxone, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Suboxone Tooth Decay Lawsuits Consolidated in MDL

In February 2024, dozens of Suboxone tooth decay lawsuits were centralized and coordinated into a single federal court, under one judge. All of these Suboxone lawsuits allege that drug-makers knew, but failed to warn patients, that Suboxone is naturally acidic and can lead to tooth decay, cavities, and other dental problems with long-term use.

The Suboxone Multi-District Litigation (MDL) is IN RE: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation — Case Number 1:24-md-03092.

What is Suboxone?

Suboxone (buprenorphine/naloxone) is a prescription medication used to treat dependence on opioid drugs. It is given as a pill or tab that dissolves under the tongue or inside of the cheek, and works to reduce withdrawal symptoms when stopping opioids and for an extended period of time. Suboxone is manufactured and marketed by Indivior Inc., and was approved by the FDA in October 2002.

FDA Warns About Dental Problems With Suboxone

The FDA on Jan. 12, 2022, issued a warning [1.] which stated that patients using sublingual medicines containing buprenorphine — including Suboxone — have reported serious dental problems, even among individuals with no history of dental issues. These Suboxone teeth problems include oral infections, tooth decay, cavities, and tooth loss.

FDA is aware of more than 300 cases of tooth decay and other serious dental problems reported among patients treated with buprenorphine, most often among individuals in their 40s; however, dental problems have also been seen in people as young as 18 years old. Some dental side effects from Suboxone occurred as soon as 2 weeks after beginning treatment, FDA said.
As a result of these problems, the agency is requiring a new warning to be added to prescribing information and other documentation to advise patients and clinicians about the risks of dental side effects with Suboxone.

Suboxone Side Effects

Our lawyers are reviewing potential lawsuits for individuals who used Suboxone and suffered from any of the following complications:

Tooth decay
Cracked teeth
Cavities
Oral infections
Tooth loss
Dental Caries (loss of enamel, dentine, or other tooth substances)
Root canal
Tooth extraction
Crown replacement

Why Do Teeth Decay on Suboxone?

Both Suboxone strips and tablets are required to dissolve in your mouth to be effective. The drugs must remain in close contact with your oral tissues while they dissolve.

Dental side effects of Suboxone occur due to:

Acidity: Suboxone is acidic, with a 3.4 pH when dissolved in water. This acidic solution causes tooth enamel to wear away, allowing the teeth to succumb to bacterial decay.
Dryness: Many Suboxone users have a low amount of saliva. Teeth that do not have enough fluid are vulnerable to decay.
Poor habits: Some patients who use Suboxone also smoke, drink sugary beverages, and have limited access to dental care, all of which increase the risk of dental disease.

Suboxone Studies

Case reports linking Suboxone to dental health problems were reported in the medical literature nearly a decade before these side effects were warned about on the drug’s labeling.

In October 2013, a case report in The Primary Care Companion [2.] described a patient who experienced severe oral health complications after taking Suboxone tablets for 18 months. The patient, who had been prescribed Suboxone for Opioid Use Disorder, required extensive dental treatment for decay in multiple teeth. The study’s authors concluded that extended use of sublingual Suboxone was the likely culprit behind the patient’s dental decline.

The lead researcher in that case report went on to publish a case series featuring 11 patients who suffered dental health problems after being prescribed Suboxone at Brigham and Women’s Hospital in Boston. The patients encountered dental caries, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions.

A December 2022 study published in JAMA [3.] looked at the use of sublingual Suboxone and the occurrence of dental side effects.

The researchers created a cohort of new users of sublingual Suboxone and 2 active comparator groups — 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 included in the cohort.

Increased adverse dental outcomes were linked to sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone. The authors concluded that due to the acidic nature of sublingual buprenorphine/naloxone, prolonged exposure to the drugs in the mouth could lead to tooth decay.

What are Suboxone Lawsuits Alleging?

Following the Jan. 2022 FDA update, a growing number of lawsuits have been filed against Indivior Inc. and its affiliated businesses alleging that the companies failed to adequately warn about the risk of tooth decay and other dental side effects of Suboxone.

The lawsuits further allege that Indivior placed its market position and profits above consumer safety, which has caused users to suffer from dental problems that were not originally warned about.

Suboxone Lawsuit Alleges Tooth Decay, Dental Damage

The first Suboxone tooth decay lawsuit was filed 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 entered in the U.S. District Court for the Northern District of Ohio on behalf of Plaintiff David Sorensen, who indicates that he became addicted to opioids after using them for pain management treatment and was subsequently prescribed Suboxone to treat his addiction. Following his use of Suboxone, Sorensen developed permanent tooth decay and has required extensive dental work as a result, according to the lawsuit.

Sorensen further alleges that Indivior was aware of the tooth decay risks of Suboxone long before the FDA warning, but failed to adequately warn the public. By the end of 2010, the company had submitted at least 20 reports to the FDA of patients who experienced tooth decay and other serious dental side effects after using Suboxone.

The Suboxone lawsuit was filed against Indivior, Inc., Aquestive Therapeutics, MonoSol Rx, Inc. and Beckitt Benckiser LLC.

If You are Taking Suboxone

If you are currently taking Suboxone, the FDA recommends that you continue taking the medication as prescribed and not to discontinue use without consulting a physician. Suddenly stopping treatment with Suboxone could lead to severe health consequences, including withdrawal symptoms or opioid relapse, which can result in an overdose and death.

How to Prevent Tooth Decay While on Suboxone

The FDA recommends that Suboxone users should take extra steps to help lessen the risk of serious dental problems. After Suboxone is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. Wait at least an hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state.

Do I have a Suboxone Tooth Decay Lawsuit?

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