Suboxone History

Suboxone (buprenorphine and naloxone) is a drug approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.

Suboxone was first approved as a tablet to be taken under the tongue to treat opioid addiction. In 2015, it was approved as a film to be placed inside the cheek to treat pain.

Suboxone is currently manufactured by Indivor, Inc., a former division of the British pharmaceutical company Reckitt Benckiser.

In 2019, the Department of Justice indicted Indivor, Inc., for false marketing claims and a scheme to direct patients to doctors who were likely to prescribe Suboxone.

The FDA Warns of Severe Dental Problems Related to Suboxone in 2022.

The U.S. Food and Drug Administration (FDA) on January 12, 2022, issued a warning 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.

As a result, the FDA is requiring 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.

 Up until 2022, no form of the Suboxone drugs contained any warning about tooth decay or dental problems.

At the time, the FDA indicated there had been more than 300 cases of tooth decay and dental problems reported among patients using orally dissolvable buprenorphine medications on an annual basis.

Study Shows Dental Problems

Related to Suboxone

In December 2022, the Journal of the American Medical Association (JAMA) published a study that looked at sublingual Suboxone and dental adverse events.

The researchers took a random sample of patients from 2006 to 2020.  Over 31,000 users were identified and included in the study.

The study found an increase in the risk of adverse dental outcomes. 

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.

PH Acid Level and Suboxone

Suboxone has a low pH, with a value of 3.4 when dissolved in water.

The pH scale measures acidity or alkalinity, ranging from 0 to 14. A pH of 7 is neutral, while values below 7 indicate acidity and above 7 indicate alkalinity.

The mouth naturally maintains a slightly acidic pH, usually between 6.2 and 7.0.

Tooth enamel, the protective outer layer of teeth, demineralizes (loses minerals) when exposed to acids.

When the mouth’s pH becomes too acidic (below 5.5), it creates conditions where enamel starts to dissolve, a process called demineralization.

Frequent exposure to acidic conditions weakens tooth enamel over time, making it more vulnerable to decay.