FDA Warns Suboxone Linked to Severe Dental Problems
On January 12, 2022, The U.S. Food and Drug Administration (FDA) issued a notice [1.] to patients and physicians that oral Suboxone products (buprenorphine) may put patients at an increased risk of dental decay, infections, cavities, and possibly tooth loss. Side effects of Suboxone usage can be severe, and persons with no history of dental disease may be affected.
FDA indicates there have been over 300 cases of tooth decay and other serious dental problems reported among Suboxone users, most commonly involving patients in their 40s; however, dental problems have also been seen among individuals 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 paperwork and other documentation to advise patients and clinicians about the risks to dental health.
What is Suboxone?
Manufactured and marketed by Indivor, Suboxone is a combination of buprenorphine and naloxone, medications used to:
- Help people to withdraw from heroin and methadone
- Reduce the need to use heroin (buprenorphine maintenance)
- Treat severe pain
Buprenorphine works 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 was approved by the U.S. Food and Drug Administration (FDA) in October 2002.
Suboxone Side Effects
Serious dental injuries linked to 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
Lawsuit Claims Suboxone Caused Permanent Dental Side Effects
An Ohio woman claims her teeth were permanently damaged by the dental side effects of Suboxone, stating that the manufacturer failed to adequately warn about the drug’s high acidity and risk of tooth decay.
The complaint was filed in September 2023 in the Northern District of Ohio on behalf of Plaintiff Teresita Badalamenti, who alleges that she suffered permanent tooth damage which required substantial dental work to repair after being prescribed Suboxone for opioid addiction.
Neither Badalamenti nor her doctors were warned about possible tooth decay and damage, according to the lawsuit. Plaintiff cites numerous incident reports received by Indivior prior to the 2022 Suboxone warning label update, as well as studies and case reports which the lawsuit indicates make it clear the company was aware of the risk of Suboxone dental damage, but placed profits ahead of consumer safety.
“Of the adverse events reported to FDA before the mandated label change, 40% were classified as serious. Over one-third reported the problem as affecting two or more teeth,” the lawsuit states. “Some of the adverse events were reported in patients with no prior history of dental issues.”
Badalamenti is pursuing financial damages from Suboxone’s manufacturers, Indivior, Inc., as well as Aquestive Therapeutics, MonoSol, RX, Inc., and Reckitt Benkiser, LLC.
What To Do if You Use Suboxone
If you are using Suboxone, the FDA recommends that you should continue taking the medicine as prescribed. Do not suddenly stop using Suboxone without first talking to your doctor, as it could lead to serious consequences.
Suboxone patients should consult their physician if they have a history of tooth problems, including cavities, before beginning treatment with the drug. They should also schedule a dentist appointment immediately after starting treatment with Suboxone, and inform their dentist they are taking the medication.
If you are concerned about the risk of tooth decay or other serious side effects of Suboxone, consult your physician about other medications with fewer health risks.
How to Take Suboxone
FDA recommends patients take a large sip of water, swish it gently and swallow once Suboxone is completely dissolved in the mouth. They should then wait at least an hour before brushing their teeth to avoid tooth damage and to give their mouth a chance to return to its natural state.
Do I Have a Suboxone Tooth Decay Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Suboxone Lawsuits. We are handling individual litigation nationwide and currently accepting new tooth decay 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 Suboxone Tooth Decay Class Action Lawsuit and our lawyers can help.