Problems with Suboxone Sublingual Film

Suboxone (buprenorphine and naloxone) is a treatment for opioid dependence originally developed by Reckitt Benckiser’s pharmaceutical division, which later demerged and became Indivior Inc.

A tablet form of Suboxone was first approved by the U.S. Food and Drug Administration (FDA) in October 2002, amidst the escalating opioid epidemic largely caused by the over-prescribing of opioid pain relievers and the rampant use of illicit heroin street drugs.

As the original patent on the drug was set to expire in October 2009, which would have allowed generic versions of Suboxone to enter the market and drive prices down, Reckitt instructed its subsidiary company, Indivior Inc. to begin developing a new sublingual film version of Suboxone with the same ingredients in an effort to secure a new patent and remain the sole provider of this highly in-demand class of opioid treatment drugs.

Shortly after the sublingual film version of Suboxone received FDA approval in August 2010, Reckitt launched a campaign to remove the pill version of the drug from the market, telling officials that the pill version was unsafe, citing concerns of child safety.

Suboxone Settlement with The Department of Justice

However, the move was seen by federal officials as an attempt to persuade the FDA from approving future generic pill forms of the drug to limit Reckitt’s competition. The use of these alleged tactics led to the U.S. Department of Justice filing an antitrust lawsuit against the manufacturer, claiming Reckitt Benckiser Group PLC prevented a fair market for their own financial gain.

Ultimately, the Suboxone antitrust lawsuit settled for $1.4 billion in July 2019, when Reckitt Benckiser agreed to pay $1.4 billion to the federal government, several states, and the FTC to resolve its potential criminal and civil liability related to the federal investigation of the marketing of the opioid addiction treatment drug Suboxone.

The settlement included a forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million.

Suboxone Tooth Decay Reports Ignored

As Reckitt deployed its sublingual film version of Suboxone to keep exclusive market share of the Suboxone class of drugs, the manufacturer ignored a growing number of dental problems caused by Suboxone being reported by users to the FDA.

In addition to the manufacturers failure to warn about Suboxone side effects, lawsuits claim that the sublingual film version of the drug contains a dangerous design defect that blocks saliva production and introduces the highly acidic buprenorphine drug directly to the users teeth, both of which have been found to cause tooth decay and dental complications.

Does Suboxone Cause Tooth Decay?

Yes. Suboxone sublingual strips decrease saliva production and introduce highly acidic conditions in the mouth, both of which have been shown to negatively affect dental health by wearing down enamel and diminishing the protective saliva around the teeth.

Suboxone Promotes Tooth Decay

Suboxone sublingual films are notably acidic, which can contribute to tooth decay. When these films dissolve under the tongue, they introduce this acidity to the mouth. This acidic environment can weaken tooth enamel, the protective outer layer of teeth. When enamel erodes, the teeth’s inner layer, dentin, becomes more exposed and vulnerable to decay.

Suboxone Film Dental Risks Nearly 2x Greater than Other Versions

A research letter titled “Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease” was issued in the JAMA medical journal in December 2022, alerting healthcare professionals to the possible dental risks linked with prolonged use of sublingual or buccal buprenorphine medications.

Analyzing data from 21,404 individuals on buprenorphine and naloxone combo drugs, the study discovered that those using sublingual versions like Suboxone were nearly 2x more likely to suffer dental problems compared to the other user groups, finding;

Dental Problems per 1,000 Users:

• Under-the-tongue version: 21.6
• Patch users: 12.2
• Pill users: 10.9

When it came to severe dental problems, such as cavities or lost teeth, the rates were 8.2 for sublingual users, compared to 3.5 for patch users, and 3.8 for pill users out of 1,000.

Researchers concluded their study warning that;

“This study found an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone. 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.”

Suboxone Blocks Saliva Production

Suboxone films can cause dry mouth due to buprenorphine known risk of suppressing acetylcholine, which is a neurotransmitter that stimulates saliva production. This makes it harder for the body to produce saliva.

Case Study Warns Suboxone Inhibits Saliva Production

A research article published in The Primary Care Companion for CNS Disorders in October 2013, researchers investigated a select group of individuals who experienced deteriorating dental health after consuming buprenorphine medications.

The study revealed that a staggering 90% of participants on buprenorphine medications exhibited saliva levels significantly below average, with a decrease of about 50% compared to the national mean. Additionally, the research pointed out that buprenorphine/naloxone drugs, when dissolved in water, possess a notably acidic pH of 3.4.

The findings suggest that Suboxone’s hindrance of salivary secretion, paired with the extended contact of the acidic buprenorphine medication, can promote dental issues.

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