An Ohio man has filed a lawsuit against the makers of Suboxone, a drug used for treating opioid addiction, claiming it caused severe dental injuries. The Suboxone lawsuit shines a spotlight on yet another aspect of the ongoing opioid crisis that affects nearly 4% of all Americans.

Keith King was issued an opioid prescription for pain management and later given Suboxone to treat the opioid disorder that followed, according to the complaint. King maintains that after 16 months on Suboxone he suffered severe tooth decay and eventually had several teeth extracted. He claims the manufacturers knew Suboxone could cause tooth decay and failed to warn users.

The product liability case, which was filed in early October, lists the defendants as Indivior Inc., Indivior PLC, Indivior Solutions Inc., Aquestive Therapeutics Inc., MonoSol Rx Inc., Reckitt Benckiser LLC. and Reckitt Benckiser Healthcare (UK) Ltd.

Active Ingredient Buprenorphine Prompts Boxed Warning

Suboxone comes as a tablet or film that is dissolved in the mouth several times a day. It has two active ingredients, naloxone and buprenorphine, which is acidic. Buprenorphine was first approved by the U.S. Food and Drug Administration in 2002 as a dissolvable tablet to treat opioid use disorder.

In 2015, a buprenorphine film was approved that could be placed inside the cheek to dissolve. The drug has an acidic pH of 3.4, which is equivalent to grapefruit, orange juice or sauerkraut.

After two decades on the market, the FDA released a warning to buprenorphine users that it could cause dental problems but stated the benefits outweighed the risks. 

“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,” according to the FDA. “Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.”

As a result, the FDA required Suboxone to include a patient medication guide and warning label that it could cause dental injuries. The warning label was added in June 2022.

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Suboxone Dental Injuries and Lawsuits

Millions of Americans have been prescribed Suboxone and could have suffered dental problems. Many people are now filing Suboxone dental problem lawsuits as a result. 

People who were prescribed dissolvable Suboxone tablets or films for pain management or opioid addiction for at least six months and suffered dental problems could be eligible to file a lawsuit. Dental injuries include:

  • Cavities
  • Gum Injuries
  • Tongue Injuries
  • Tooth Decay
  • Tooth Fractures
  • Tooth Loss

Users must have seen a dentist at some point before starting Suboxone to qualify. This type of lawsuit is in its early stages.

This isn’t the first time Suboxone has been known to cause dental injuries. A small study conducted by the Partners Human Research Committee in 2012 found that a majority of patients in the study reported dental problems. 

“Consistent with prior reports, patients in this case series reported a wide variety of dental problems requiring intervention. The majority of patients also reported experiencing toothache pain at the time of assessment,” according to the study.